DCGI slaps show cause notice on GSK for running HPV ad in media

The Drug Controller General of India (DCGI) has eventually issued a show-cause notice to the GlaxoSmithKline (GSK) for launching an advertisement campaign in the national media on cervical cancer vaccine without taking prior approval from his office.

The details can be read here.

Glenmark Pharma's US subsidiary receives two tentative approvals from US FDA

Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics, has received tentative approval from US FDA for pramipexole dihydrochloride tablets, the generic version of Boehringer Ingelheim’s Mirapex tablets and Atomoxetine hydrochloride capsules, the generic version of Lilly’s Strattera.

the details can be read here.

Ranbaxy subsidiary Ohm receives Warning Letter from US FDA for cGMP violations

Ohm Laboratories Inc (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited, has received a Warning Letter, dated December 21, 2009, from the USFDA, for its liquid manufacturing facility located in Gloversville, New York, USA.

The details can be read here.

Schering, MSP Singapore sue Mylan for cholesterol drug Vytorin

Mylan Inc confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc have been sued by Schering Corporation and MSP Singapore Company in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Ezetimibe and Simvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg.

The details can be read here.

WHO grants prequalification to Novaritis' 3 influenza A vaccines

Novartis announced that the World Health Organization (WHO) has granted prequalification for all three of its influenza A (H1N1) 2009 monovalent vaccines for supply to United Nations (UN) agencies: the cell culture-based and MF59 adjuvanted vaccine Celtura, the egg-based and MF59 adjuvanted vaccine Focetria as well as the egg-based A(H1N1) vaccine manufactured using the seasonal Fluvirin platform.

The details can be read here.

GSK undertakes to withdraw ad on cervical cancer vaccine to DCGI

After almost a month of advertisement blitzkrieg in several national newspapers on cervical cancer vaccine, in gross violation of Drugs & Cosmetics Act, 1940 and Drugs and Magical Remedies Act 1954, the GlaxoSmithKline (GSK) has given an assurance to the Drug Controller General of India (DCGI) that it is unilaterally withdrawing the ads, it is learnt.

The details can be read here.

Lupin settles Alzheimer drug litigation with Forest Laboratories

Lupin has settled all ongoing Hatch-Waxman litigation relating to Memantine tablets with Forest Laboratories, Inc. Memantine tablets are Lupin's generic version of Forest's Alzheimer disease treatment Namenda tablets.

The details can be read here.

Ligand Announces Positive Regulatory Opinion in Europe for Revolade for Chronic Immune Thrombocytopenic Purpura

Dec 18, 2009 - Ligand Pharmaceuticals Incorporated today announced that its partner GlaxoSmithKline has received a positive opinion for Revolade® (eltrombopag/Promacta®) from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).

The details can be read here.

Prophylaxis of Influenza in Infants and Children Approved as an Additional Indication of Anti-influenza Drug Tamiflu

December 18, 2009 - Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; President: Osamu Nagayama (hereafter, "Chugai")] announced today that on December 18, 2009, the Ministry of Health, Labour and Welfare granted approval for the anti-influenza drug oseltamivir phosphate [product name: Tamiflu®] in an additional indication of "prophylaxis of influenza in adults, infants and children" in the formulation as Tamiflu® Dry Syrup, and it granted approval for a change in the dosage and administration for Tamiflu® Capsules in the pediatric prophylaxis indication. Chugai markets Tamiflu® in Japan.

The details can be read here.

Sepracor Granted Patent Term Extension for Lunesta and Provides Update On Lunesta Pediatric Studies

Dec. 17, 2009 -- Sepracor Inc. today announced that the United States Patent and Trademark Office has determined that U.S. Patent No. 6,444,673, which is a composition of matter patent that covers the human drug product LUNESTA® (eszopiclone), received patent term extension under 35 U.S.C. § 156.

The details can be read here.

Teva Launches Co-Beneldopa (Levodopa/Benserazide)

Teva UK Limited has launched generic co-beneldopa capsules in a variety of strengths. The company says that they are the first generic to reach the market.

"We're delighted to be launching co-beneldopa capsules," said Kim Innes, Commercial Director, Teva UK Limited. "This product fits well with our range and strengthens our position as the UK's leading generics supplier.

The details can be read here.

Pfizer's pH1N1 vaccine for swine made available

Swine producers have a new conditionally-licensed vaccine from Pfizer Animal Health to help protect their herds from the pandemic H1N1 (pH1N1) strain of Swine Influenza Virus (SIV). Pfizer Animal Health announced that its Swine Influenza Vaccine, pH1N1 – Killed Virus, has been approved by the US Department of Agriculture (USDA) for vaccination of healthy swine, including pregnant sows and gilts, three weeks of age or older against SIV subtype H1N1.

The details can be read here.

New Indication for Procoralan: Use in Combination With Beta Blockers for Chronic Stable Angina Patients

The European Medicines Agency (EMEA) has recently approved a new indication for Procoralan*(ivabradine). Procoralan can now be administered to chronic stable angina patients, who remain inadequately controlled despite an optimal dose of beta blockers, and whose heart rate is above 60 beats per minute.

The details can be read here.

Govt to introduce Bivalent Oral Polio Vaccine as trials prove its efficacy in India

The Union Health Ministry will soon introduce the Bivalent Oral Polio Vaccine (bOPV) in specific areas of the country in its polio eradication drive as trials in India have shown that the bOPV vaccine is more efficacious than the traditionally used trivalent oral polio vaccine (tOPV).

The details can be read here.

Study shows oral insulin spray acts faster than insulin delivered subcutaneously

Published in the journal Diabetes, Obesity and Metabolism, an independent review of clinical trials of Generex Oral-lyn shows that the oral insulin spray has a faster onset of action and shorter duration of action than insulin delivered subcutaneously.

The details can be read here.

Wanbury launches anti-anaemia drug Cpink IIC

Wanbury Ltd, country’s fastest growing pharmaceutical company as per the latest ORG IMS, has launched an advanced form of its anti-anaemia drug Cpink (Ferrous Ascorbate). The product is called Cpink IIC and will be used in the treatment of anaemia in pregnant women and children.

The details can be read here.

Abbott Seeks FDA Approval of New Dosage Strengths of Simcor (niacin extended-release/simvastatin)

Abbott has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR®, a cholesterol medication. SIMCOR is a fixed-dose combination of niacin extended-release and simvastatin.

The details can be read here.

Protalix Completes NDA Submission for taliglucerase alfa for the Treatment of Gaucher's Disease

Dec 9, 2009 - Protalix Biotherapeutics, Inc. (NYSE-Amex: PLX) today announced the completion of its New Drug Application (NDA) submission with the U.S. Food and Drug Administration (FDA) for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for the potential treatment of Gaucher's disease.

The details can be read here.

Eurand Granted FDA Approval for ZENPEP First and Only FDA-Approved Pancreatic Enzyme Product Clinically Tested in Patients Under 12 Years Old

August 28, 2009) - Eurand N.V., a specialty pharmaceutical company, today announced U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for ZENPEP™ (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.

The details can be read here.

Trial Date Set for Cubicin Patent Litigation

Dec 11, 2009 - Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that a trial date has been set for patent litigation in the U.S. District Court for the District of Delaware against Teva Parenteral Medicines, Inc. (TPM), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. alleging infringement of Cubist's US Patent Nos. 6,468,967 and 6,852,689, which expire on September 24, 2019, and US Patent No. RE39,071, which expires on June 15, 2016.

The details can be read here.

Mylan Receives Approval for Generic Version of Antiepileptic Keppra 1000 mg

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 1000 mg. Levetiracetam Tablets are the generic version of UCB Pharma's antiepileptic Keppra®.

The details can be read here.

Perrigo Confirms Filing for Generic Version of Clobex(R) Spray and Announcement of Lawsuit by Galderma and Dermalogix

Perrigo Company today announced that it has filed an Abbreviated New Drug Application for Clobetasol Propionate Topical Spray, 0.05%, a generic form of Clobex® Spray.

The details can be read here.

Lannett Receives FDA Approvals for Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg and 8 mg Strengths

Dec 10, 2009 - Lannett Company, Inc. today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg and 8 mg, the generic equivalent of Purdue Pharmaceuticals' (formerly Abbott's) Dilaudid® Tablets 2 mg, 4 mg and 8 mg.

The details can be read here.

Alkermes licenses long-acting fusion proteins, Medifusion technology from Acceleron Pharma

Alkermes, Inc and Acceleron Pharma, Inc announced that Alkermes has licensed a proprietary long-acting Fc fusion technology platform, called the Medifusion technology, which is designed to extend the circulating half-life of proteins and peptides. The first drug candidate being developed with this technology is a long-acting form of a TNF receptor-Fc fusion protein for the treatment of rheumatoid arthritis (RA) and related autoimmune diseases.

The details can be read here.

St. John's selected for GSK's H1N1 vaccine ‘Pandemrix’ trial on 50 volunteers

GlaxoSmithKline (GSK) has selected St John’s National Academy of Health Sciences as one of the five locations to conduct the trial for the H1N1 vaccine ‘Pandemrix’ in the country. The trial is expected to commence by the month-end.

The details can be read here.

BHR Pharma Files Investigational New Drug Application, Receives Orphan Drug Designation, for Traumatic Brain Injury Treatment

BHR Pharma, LLC (BHR) announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its proprietary BHR-100 intravenous progesterone infusion product.

The details can be read here.

Mylan Announces Settlement Agreement Related to Antidepressant Effexor XR

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into settlement and license agreements with Wyeth, now part of Pfizer, relating to Venlafaxine Hydrochloride (HCl) Extended Release (ER) Capsules, 37.5 mg, 75 mg and 150 mg, the generic version of Wyeth's Effexor XR® Capsules, a treatment for major depressive disorder.

The details can be read here.

Biovel Lifesciences up for sale, looking for potential bio-pharma buyers

Bangalore-based biopharmaceutical start-up Biovel Lifesciences is looking to exit from the life sciences space and is keen for an early outright buyout. Biovel has been in dialogue with several companies including Ranbaxy, Avesthagen, Shantha Biotechnics Ltd and Orchid Chemicals, it is learnt.

The details can be read here.

NanoBio says new intranasal nanoemulsion vaccine adjuvant also effective by subcutaneous & intramuscular injection

NanoBio Corporation announced positive results from studies in mice in which immune responses were evaluated following administration of 5µg doses of recombinant H5N1 pandemic flu antigen combined with the company’s novel nanoemulsion vaccine.

The details can be read here.

Voltaren Gel (diclofenac sodium topical gel) - Hepatic Effects Labeling Change: Cases of drug-induced hepatotoxicity reported

Dec. 5, 2009-Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the Prescribing Information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

The details can be read here.

Somaxon Receives Complete Response Letter from the FDA for Silenor NDA

Dec 7, 2009 - Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

The details can be read here.

FDA Approves Lilly's Zyprexa for Two Adolescent Indications

The U.S. Food and Drug Administration (FDA) today approved Zyprexa® (olanzapine) in tablet form as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old.

The details can be read here.

Santarus Receives FDA Approval for Immediate-Release Omeprazole Tablet with Dual Buffers

Dec 5, 2009 - Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for immediate-release omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole.

The details can be read here.

FDA Grants First Approval for a Product Derived from Pichia pastoris

Dec 7, 2009 - RCT licensee Dyax Corp. has received approval from the U.S. Food and Drug Administration for KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

The details can be read here.

Tris Pharma Announces Two NDA Approvals from FDA including a Pioneering, First-Ever 24 hour Liquid Sustained Release Product

Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced that the US Food and Drug Administration (FDA) has approved its first two New Drug Applications (NDAs) based on its proprietary OralXR+TM platform technology including the first-ever 24 hour liquid sustained release product.

the details can be read here.

Higher studies of 50,000 pharmacy graduates in trouble as no decision yet on GATE exams

The higher studies of around 50,000 pharmacy graduates in the country are still hanging in balance, with no decision on conducting the graduate aptitude test for engineering (GATE) exams for pharmacy which would have brought them both recognition and the necessary funds.

The details can be read here.

Impax Labs acquires ANDAs from Watson & Cobalt

Impax Laboratories, Inc announced it acquired Abbreviated New Drug Applications (ANDA) from Watson Pharmaceuticals and Cobalt Laboratories, a subsidiary of Arrow Group.

The details can be read here.

ICON Receives Warning Letter Relating to Two Studies

Dec 4, 2009 - ICON plc, today announced it has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding clinical study management services provided by the company to one of its clients in relation to two studies conducted between 2004 and 2006.

The details can be read here.

Janssen-Cilag Submits Marketing Authorisation Application in Europe for Paliperidone Palmitate for the Treatment of Schizophrenia

(December 4, 2009) -- Janssen-Cilag International NV, has submitted a Marketing Authorisation Application to the European Medicines Agency for paliperidone palmitate, an investigational once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia.

The details can be read here.

US FDA Approves SEROQUEL XR For Add-On Treatment of Major Depressive Disorder

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD).

The details can be read here.

Watson Files FDA Application for Generic Rozerem

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.-Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 8mg ramelteon tablets prior to the expiration of a patent owned by Takeda Pharmaceutical Company Limited.

The details can be read here.

Cadila Healthcare may approach SC on Sec 3(d) of Patent Act on clopidogrel case

The Ahmedabad-based Cadila Healthcare may approach the Supreme Court seeking interpretation of the controversial Section 3(d) of the Indian Patent Act. The company has lost its case against the Hyderabad-based Glochem Industries Ltd to retain patent protection for its antiplatelet drug, clopidogrel besylate, it is learnt.

The details can be read here.

Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter: Association between Lexiva and myocardial infarction in HIV infected adults

Dec. 3, 2009-GlaxoSmithKline and FDA notified healthcare professionals of a potential association between Lexiva and myocardial infarction and dyslipidemia in HIV infected adults. GSK has modified the existing Warnings and Precautions section of the Prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with LEXIVA and at periodic intervals during therapy.


The details can be read here.

Endo Pharmaceuticals Provides Regulatory Update on AVEED (Testosterone Undecanoate) Injection

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone. Low testosterone is also known as hypogonadism.

The details can be read here.

Novartis Receives Approval In The European Union For Onbrez Breezhaler, A New Once-Daily Bronchodilator For Patients With COPD

December 3, 2009 - Novartis announced today that the European Commission (EC) has approved Onbrez Breezhaler (QAB149 or indacaterol) in both 150 mcg and 300 mcg doses as a new once-daily maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).

The details can be read here.

Cephalon Files Patent Infringement Lawsuit Against Teva Pharmaceuticals

Cephalon, Inc. today announced that it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570, 7,297,346 (the "'346 Patent") and RE37,516 (for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV].

The details can be read here.

Shire and Teva Settle Litigation Concerning Supply of ADDERALL XR Authorized Generic

Shire plc, the global specialty biopharmaceutical company, announces that it has settled the litigation with Teva Pharmaceuticals USA, Inc. ("Teva") over Shire's supply to Teva of an authorized generic version of ADDERALL XR. Shire has been supplying Teva with authorized generic ADDERALL XR since April 1, 2009.

The details can be read here.

Stallergenes gets European nod to market Oralair

Stallergenes has been granted European approval to market Oralair in both adults and children through a Mutual Recognition Procedure. Germany, the first country where Oralair has been marketed, was the reference Member state.


The details can be read here.

Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Relapsed/Refractory Multiple Myeloma

Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.

The details can be read here.

Javelin Pharmaceuticals Submits Dyloject New Drug Application to FDA for Management of Acute Moderate-to-Severe Pain in Adults

Dec 2, 2009 - Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, for the management of acute moderate-to-severe pain in adults.

The details can be read here.

Teva Announces the Submission of a Biologics License Application (BLA) for XM02 for the Treatment of Chemotherapy-Induced Neutropenia

Dec 1, 2009 - Teva Pharmaceutical Industries Ltd., today announced the submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

The details can be read here.

FDA Approves 10 mcg Dose of Vagifem for the Treatment of Atrophic Vaginitis Due to Menopause

Novo Nordisk said today that the U.S. Food and Drug Administration (FDA) has approved a 10 mcg dose formulation of Vagifem® (estradiol vaginal tablets) for the treatment of atrophic vaginitis due to menopause - a condition experienced by up to 75 percent of postmenopausal women.

The details can be read here.

Bayer’s Betaferon approved in China for Treatment of Multiple Sclerosis

December 1, 2009 - Bayer Schering Pharma AG announced today that the Chinese State Food and Drug Administration (SFDA) has approved Betaferon® (interferon beta-1b) therapy for patients with relapsing-remitting multiple sclerosis (MS).


The details can be read here.

Dyax Announces FDA Approval of KALBITOR (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema

Dec 1, 2009 - Dyax Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted approval for KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

the details can be read here.

Santarus Announces FDA Approval of Schering-Plough HealthCare Products' ZEGERID OTC

Dec 1, 2009 - Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Schering-Plough HealthCare Products, Inc.'s, New Drug Application (NDA) for ZEGERID OTC™ Capsules (omeprazole/sodium bicarbonate) with a dosage strength of 20 mg of omeprazole for over-the-counter (OTC) treatment of frequent heartburn.

The details can be read here.

DCGI to notify guidelines to Spurious Drugs Bill soon, draft sent to Law Ministry

Thousands of genuine drug manufacturers, who were apprehensive about the sweeping powers accorded to the drug inspectors under the newly amended Drugs and Cosmetics Act, can heave a sigh of relief as the Drug Controller General of India (DCGI) has eventually decided to notify the guidelines attached to the spurious Drugs Bill.

The details can be read here.

Indus Biotech awaits DCGI clearance for its botanical H1N1 drug to start trials

Indus Biotech is awaiting clearance from the Drugs Controller General of India for its H1N1 drug that is ready for clinical trials. The company has submitted IND (Investigational New Drug) dossiers in September.

The details can be read here.

Jubilant & Eli Lilly extend drug discovery collaboration

Jubilant Organosys and Eli Lilly have extended drug discovery collaboration agreement for next five years as their four years old research collaboration has successfully delivered multiple discovery milestones and pre-clinical candidates. Jubilant and Lilly had entered into an initial discovery research collaboration in late 2005.

The details can be read here.

Depomed Files Patent Infringement Lawsuit Against Lupin Limited

Nov 30, 2009 - Depomed, Inc. today announced that it has filed a lawsuit in the United States District Court for the Northern District of California against Lupin Limited and its wholly-owned subsidiary, Lupin Pharmaceuticals, Inc., for infringement of the patents listed in the Orange Book for GLUMETZA® (metformin hydrochloride extended release tablets).

The details can be read here.

Abbott, Teva Reach Deal That Delays Generic TriCor

Abbott Laboratories said Monday that it has reached a deal with Teva Pharmaceuticals that postpones the sale of a generic version of the blockbuster cholesterol drug TriCor until March 28, 2011, at the earliest.

The details can be read here.

Suven gets 3 European patents on NCEs for neurodegenerative disorders

Suven Life Sciences Ltd (Suven) announces that the European Patent Office (EPO) has issued three new patents: EP1537113, EP1704154 and EP1856132 corresponding to three New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these Patents are valid until 2022,23 and 24 respectively.

The details can be read here.

Pfizer, Astellas to launch Caduet combo tabs in Japan on Dec 2

Pfizer Japan Inc and Astellas Pharma Inc announced that combination drug of hypertension treatment and hypercholesterolemia treatment Caduet Combination Tablets (generic name: amlodipine besylate and atorvastatin calcium) will be launched on December 2, 2009 in Japan.

the details can be read here.

Merck KGaA Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application

Merck KGaA announced today that its US affiliate received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets, Merck Serono’s proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS).

The details can be read here.

Bavarian Nordic will file for market approval for Imvamune in Canada

November 30, 2009 - Bavarian Nordic A/S announced today that the company expects to file a New Drug Submission (NDS) for its third-generation smallpox vaccine, IMVAMUNE® with the Canadian Authorities, Health Canada in 2010. If successful, this would be the first marketing approval of IMVAMUNE®.

The details can be read here.

Sanofi-aventis: Multaq Approved in the European Union for Patients With Atrial Fibrillation

November 30, 2009 --Sanofi-aventis announced today that the European Commission has granted marketing authorization for Multaq(R) (dronedarone - 400mg Tablets) in all 27 European member states.

The details can be read here.

FDA Approves Cymbalta for Maintenance Treatment of Generalized Anxiety Disorder

Nov 30, 2009 -- The U.S. Food and Drug Administration (FDA) has approved Cymbalta(R) (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults, Eli Lilly and Company announced today.

The details can be read here.

FDA Approves Agriflu Seasonal Influenza Vaccine

Nov. 27, 2009--The U.S. Food and Drug Administration today approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

The details can be read here.

Health Canada Approves New Treatment Option For Canadians At High Risk Of Heart Attack Or Stroke

MICARDIS® (telmisartan) has received Health Canada approval to reduce the risk of non-fatal stroke or non-fatal myocardial infarction in patients 55 years or older at high risk of developing major cardiovascular events who cannot tolerate an angiotensin converting enzyme (ACE) inhibitor.

The details can be read here.

Astellas Pharma drops lawsuit against US FDA regarding oral immunosuppressants

Astellas Pharma Inc announced that its North American affiliate, Astellas Pharma US, Inc has dismissed its lawsuit against the US Food and Drug Administration (FDA).

The details can be read here.

Three pharma cos set to commence clinical trials of H1NI vaccines by Jan 2010

Indian efforts to develop the H1N1 vaccine are well on the course and the three Indian companies involved in the task are set to begin the clinical trials by January and hoping to roll out the final products by May-June 2010, if all goes well.

The details can be read here.

Ranbaxy Launches Generic Valtrex in U.S.

BANGALORE -- Ranbaxy Laboratories Ltd. Friday said it has launched a generic version of GlaxoSmithKline's anti-herpes medicine Valtrex in the U.S., a development expected to significantly boost its financial results.

Ranbaxy--a unit of Japan's Daiichi Sankyo Co.--launched the generic drug, valacyclovir hydrochloride, in the U.S on Nov. 25.

The details can be read here.

GlaxoSmithKline pulls swine flu vaccines in Canada

LONDON (AP) - The pharmaceutical company GlaxoSmithKline says it has advised medical staff in Canada to not use one batch of swine flu vaccine for fear it may trigger life-threatening allergies.


The details can be read here.

Natco Pharma plans to fight Teva's citizen petition for Glatiramer Acetate

Natco Pharma, a Rs 400 crore Hyderabad-based pharma company, is planning to suitably respond to Teva Pharma's Citizen Petition with the US FDA regarding Glatiramer Acetate product. Teva had alleged, that there is a significant difference between Natco's product and its Copaxone.

The details can be read here.

Indian Company bears the brunt of Section 3(d)

This post is posted on SPICY IP blog by eminent contributors.

After a series of overseas pharmaceutical companies, it is now the turn of an Indian pharmaceutical company to bear the brunt of Section 3(d). The relevant patent relates to Clopidogrel Bisulfate claimed by Cadila Healthcare, a pharmaceutical company based in Ahmedabad. A pre-grant opposition was filed by Glochem Industries, a Hyderabad based pharmaceutical company. The instant writ petition has been filed by Glochem Industries alleging misconstruction and misapplication of the law. The judgment followed the interpretation of Section 3(d) in the Novartis judgment and laid down some procedural guidelines in relation to the opposition procedure. The series of posts on Section 3(d) can be found here.

The details of the case can be read here.


The whole judgement can be read here.

Novartis opens first large-scale cell-culture influenza vaccine manufacturing facility in US

Novartis officially inaugurated the US's first ever large-scale flu cell culture vaccine and adjuvant manufacturing facility in Holly Springs, North Carolina. The facility is a result of a partnership between Novartis and the US Department of Health and Human Services (HHS).

The details can be read here.

Clavis Pharma, Clovis Oncology ink pact to develop & commercialise pancreatic cancer drug CP-4126

Clavis Pharma ASA, the clinical stage oncology focused pharmaceutical company, and Clovis Oncology, Inc, the newly formed oncology company led by former Pharmion Corporation executives, announced an agreement for the further development and commercialisation of the Clavis Pharma drug candidate, CP-4126, currently in phase-II development in pancreatic cancer.

The details can be read here.

Sun Pharma gets US FDA tentative approval for generic Strattera capsules

Sun Pharma announced that the US FDA has granted a tentative approval for an Abbreviated New Drug Application (ANDA) for generic Strattera, atomoxetine hydrochloride capsules.

The details can be read here.

GSK, Gilead enter licensing pact to commercialise HB V drug Viread in 5 Asian countries

GlaxoSmithKline (GSK) and Gilead Sciences, Inc announced a licensing agreement to commercialise Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B (HBV) infection in adults in five countries in Asia.

The details can be read here.

LFB's Recombinant Anti-CD20 Monoclonal Antibody is Granted Orphan Drug Status in Europe for Chronic Lymphocytic Leukemia

Nov 25, 2009 - The recombinant anti-CD20 monoclonal antibody produced by LFB Biotechnologies received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL).

The details can be read here.

Avastin Filed For Broader Breast Cancer Label In Europe For Use In Combination With Standard Chemotherapies

Roche announced today that they have filed to extend the current European label of Avastin (bevacizumab) in patients with metastatic breast cancer to allow its use in combination with a broader range of standard chemotherapies. Avastin is currently licensed in the EU as first-line treatment for patients with metastatic breast cancer in combination with paclitaxel or docetaxel.

The details can be read here.

Human Genome Sciences Submits Biologics License Application to FDA for ZALBIN

Nov 25, 2009 - Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ZALBIN™ (albinterferon alfa-2b) for the treatment of chronic hepatitis C.

the details can be read here.

FDA Accepts Once Daily 23 mg Aricept Extended Release NDA for Review

Eisai Inc. and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's New Drug Application (NDA) for once daily 23 mg Aricept® (donepezil HCl extended release) tablets for the treatment of moderate to severe Alzheimer's disease (AD).

The details can be read here.

Jubilant Organosys forms JV with UAB & Southern Research Institute

Jubilant Organosys has entered a Memorandum of Understanding (MoU) in Washington, DC with the University of Alabama at Birmingham (UAB), and Southern Research Institute for a joint venture (JV). The JV will focus on leveraging their collective innovation and enabling technologies in the areas of oncology, metabolic disease and infectious diseases.

The details can be read here.

FDA Grants Ibsolvmir Orphan Drug Designation In The Treatment Of Diabetes Patients In The U.S.

November 24, 2009 – TikoMed AB, a biotechnology company focused on development and commercialization of innovative treatments for immune diseases and cell therapies, today announced that IBsolvMIR® has been granted orphan drug designation for the prevention of graft rejection of pancreatic islet transplantation by the U.S. Food and Drug Administration (FDA). IBsolvMIR is a unique new treatment which could transform islet cell transplantation into a standard treatment for severe type 1 diabetes patients with unstable diabetic conditions.

The details can be read here.

Biolaxy Secures IND Approval for Oral Insulin

Shanghai Biolaxy announced the Chinese State Food & Drug Administration (SFDA) has approved the investigational new drug application (IND) for its oral insulin project (Nodlin), an innovative insulin formulation to treat diabetes. This IND approval allows Biolaxy to initiate its first phase I clinical study.

The details can be read here.

PROLOR Biotech Reports Merck Receives Positive Regulatory Opinion for European Marketing of Long-Acting CTP-Modified Fertility Treatment ELONVA(R)

PROLOR Biotech, Inc., today noted the positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for marketing approval in Europe for ELONVA®, a long-acting CTP-modified version of the fertility hormone FSH from Merck & Co. Merck and PROLOR are both licensees of the CTP technology from Washington University in St. Louis.

The details can be read here.

Shire Submits European Marketing Authorization Application (MAA) for velaglucerase alfa for the Treatment of Type 1 Gaucher Disease

November 24-- Shire plc, the global specialty biopharmaceutical company, today announced that it has submitted a MAA to the European Medicines Agency for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.

the details can be read here.

Nutra Pharma launches chronic pain reliever, Nyloxin OTC

Nutra Pharma, a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), introduced Nyloxin OTC, an over-the-counter pain reliever, that will be marketed and sold through international distribution channels alongside the company’s prescription pain reliever, Nyloxin Rx.

The details can be read here.

Aurobindo Pharma commissions formulation facility in Hyderabad SEZ

Aurobindo Pharma, a Hyderabad based Rs 2,950 crore plus pharma company, has commissioned its formulations manufacturing facility (Unit VII) in Hyderabad from November 20, 2009.

The details can be read here.

US FDA committee backs Pfizer's invasive pneumococcal disease vaccine, Prevnar for kids

Pfizer Inc announced that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to one that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children.

The details can be read here.

Oceanside Pharmaceuticals Announces Launch of Librax AG

Oceanside Pharmaceuticals, part of Valeant Pharmaceuticals International, today announced that it has now launched chlordiazepoxide hydrochloride and clidinium bromide, an authorized generic (AG) version of Librax®. Oceanside has received its first orders and expects to be a significant player in the Librax® generic market.

The details can be read here.

U.S. FDA Approves Abilify (aripiprazole) for the Treatment of Irritability Associated with Autistic Disorder in Pediatric Patients

Nov 20, 2009 - Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. FDA has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

The details can be read here.

Pfizer Receives FDA Approval For Geodon (Ziprasidone HCI) Capsules For The Adjunctive Maintenance Treatment Of Bipolar Disorder In Adults

Nov 20, 2009 - Pfizer today announced that the U.S. Food and Drug Administration (FDA) has approved Geodon® (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults.

The details can be read here.

FDA Approves Intravenous Formulation Of Pfizer's Revatio (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension

Nov 20, 2009 - Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.

the details can be read here.

FDA Extends NDA Review for Exalgo Extended-Release Tablets

Nov 20, 2009 - CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months.

The details can be read here.

Novartis says flu vaccine US interim data shows lower doses of antigen may suffice to generate a protective immune response against A(H1N1)

Novartis announced new interim data from ongoing clinical trials demonstrating that a single 7.5µg dose of the company's influenza A(H1N1) 2009 unadjuvanted vaccine, half of the currently-approved US dose, fulfilled immune response criteria associated with protection in adults and the elderly (>=65 years of age).

The details can be read here.

AstraZeneca Submits US New Drug Application for Ticagrelor (Brilinta), an Investigational Antiplatelet Agent

AstraZeneca today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).

The details can be read here.

Astellas and XenoPort Announce Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome

Nov 19, 2009 - Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

The details can be read here.

Otsuka Pharmaceutical Europe Ltd withdraws its application for an extension of indication for Abilify (aripiprazole)

Nov. 19, 2009- The European Medicines Agency has been formally notified by Otsuka Pharmaceutical Europe Ltd of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Abilify (aripiprazole) tablets, orodispersible tablets and oral solution.

The details can be read here.

US Food and Drug Administration grants priority review for Actelion's miglustat in Niemann-Pick type C disease

19 November 2009 - Actelion Ltd announced today that a supplemental new drug application (sNDA) for an extension of indication for Zavesca® (miglustat) for the treatment of progressive neurological manifestations in adult and pediatric patients with Niemann-Pick type C disease (NP-C) has been accepted by the U.S. Food and Drug Administration (FDA).

The details can be read here.

Sucampo Receives Marketing Authorization for Amitiza in Switzerland for Treatment of Chronic Idiopathic Constipation

Nov 19, 2009 - Sucampo Pharma Europe Ltd., a subsidiary of Sucampo Pharmaceuticals, Inc., today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted a marketing authorization for Amitiza® (lubiprostone) 24 microgram (mcg) gel capsules for the long-term treatment of patients with chronic idiopathic constipation (CIC).

The details can be read here.

Birth control ring NuvaRing launched in India

With the introduction of a product that will augment the contraception options currently available to Indian women, NuvaRing, the first vaginal birth control ring was formally launched in India. NuvaRing is a once-monthly vaginal ring that offers the same benefits as ‘the Pill’ but with the added convenience of not having to be used daily.

The details can be read here.

Wockhardt launches anti-hypertensive drug Nicardipine injections in USA

Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing the 25mg/10 ml injection of Nicardipine HCl, which is used for short-term management of hypertension or increased blood pressure.

the details can be read here.

Genentech and Biogen Idec Receive a Complete Response from the FDA for Rituxan for Chronic Lymphocytic Leukemia

Nov 18, 2009 - Genentech, Inc., a wholly-owned member of the Roche Group, and Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies' applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL).

The details can be read here.

NicOx announces FDA accepts naproxcinod NDA for filing

November 18, 2009-NicOx S.A. today announced that it has received a filing communication from the U.S. Food and Drug Administration (FDA) stating that the New Drug Application (NDA) for naproxcinod is accepted for filing.

The details can be read here.

Basilea's Toctino Receives Marketing Authorization in Canada

November 18, 2009 - Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has obtained regulatory approval from Health Canada.

The details can be read here.

Merz Pharmaceuticals Announces Approval of Post-stroke Upper Limb Spasticity Indication for Xeomin in the EU

Today, Merz Pharmaceuticals announced Xeomin®, the first botulinum toxin type A free from complexing proteins has been granted an extension of indication for post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults in various European countries.

The details can be read here.

Now Available: Lusedra (fospropofol disodium) Injection CIV

November 16, 2009 – EisaiInc. today announced that LUSEDRA™ (fospropofol disodium) Injection is now available for use by persons trained in the administration of general anesthesia. LUSEDRA, an aqueous solution, is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

The details can be read here.

Sun Pharma announces USFDA approval for Nicardipine injection

November 18, 2009: Sun Pharmaceutical Industries Ltd. announced that the USFDA has granted its subsidiary an approval for its application for Nicardipine Hydrochloride Injections.

the details can be read here.

GAVI Alliance manages to lower cost of pentavalent vaccines to US$ 3 per dose

The Geneva-based public-private partnership, GAVI Alliance, has managed to bring down the price of the pentavalent vaccines by 50 cents and it now costs US$ 3 per dose effective from 2010.

The details can be read here.

Nectar bags major deal form GSK in regulated markets

Nectar Life sciences Ltd, a US$ 200 million organisation, with a strong presence in anti-bacterial segment of global pharma, particularly Cephalosporins, has initiated a long term supply of its innovation molecule bulk drug (API) Cefuroxime Axetil, to the world's second largest innovator pharmaceutical company, GlaxoSmithKline.


The details can be read here.

Govt to introduce bi-valent oral polio vaccine to check rise in polio cases soon

Aiming to wipe out the polio disease from the country, the union health ministry will soon introduce bi-valent oral polio vaccine to attack the type-1 and type-3 virus to deal with the fresh outbreak of type-3 virus in several parts of the country.

The details can be read here.

FDA MedWatch - Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction

Nov. 17, 2009-FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid. New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced.

The details can be read here.

Genentech Submits Supplemental Applications to FDA for Avastin Combined with Commonly Used Chemotherapies for Women with Advanced Breast Cancer

Nov 17, 2009 - Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment).

the details can be read here.

Sinovac's PANFLU.1 (H1N1) Regulatory Approval Expanded to Include Geriatric Population

Sinovac Biotech Ltd., a leading developer and provider of vaccines in China, announced today that it received a revised production license from State Food and Drug Administration for Panflu.1, the Company's H1N1 vaccine. The population has been expanded to include people over 60 years old. The shelf life for PANFLU.1 was extended to one year from six months.

The details can be read here.

US Government Awards Contract to Bavarian Nordic for the Development of Freeze-Dried IMVAMUNE Smallpox Vaccine

November 17 2009 - Bavarian Nordic A/S announced today that BARDA (Biomedical Advanced Research and Development Authority) has awarded a new contract to Bavarian Nordic for the development of a freeze-dried version of its IMVAMUNE® smallpox vaccine with a total prospective value of USD 40 million.

The details can be read here.

Sun Pharma announces USFDA tentative approval for generic Gleevec ® tablets

November 17, 2009: Sun Pharma announced that the USFDA has granted tentative approval to an Abbreviated New Drug Application (ANDA) for generic Gleevec®, imatinib mesylate tablets.

the details can be read here.

Bafna Pharma set to launch first olmesartan brand in Sri Lanka

Bafna Pharmaceuticals, a Chennai-based pharma company, has received the approval to launch its first brand product of olmesartan medoxomil named, 'Olmebaf' in Sri Lanka for the treatment of hypertension.

the details can be read here.

Glenmark Generics gets US FDA approval for Ciclopirox Olamine cream

Glenmark Generics Limited (GGL) has received ANDA approval from the US FDA for Ciclopirox Olamine cream, 0.77 per cent and will commence marketing and distribution of this product in the US market.

The details can be read here.

Purdue Pharma sues Sun Pharma following Para IV patent filing on pain killer drug

The US based Purdue Pharma products LP and its partner Napp Pharmaceutical Group Ltd have filed a patent infringement petition against Sun Pharmaceuticals and its US arms following a para IV certification filed by the latter to manufacture and market generic version of the former's pain killer - Ryzolt - tramadol hydrochloride extended-release drug.

The details can be read here.

European Medicines Agency EMEA Recommends Orphan Drug Status for Elafin in the Treatment of Esophagus Carcinoma

Nov 16, 2009 - Proteo, Inc.and its wholly-owned subsidiary Proteo Biotech AG announced today:

The Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA) has issued a recommendation granting orphan drug status to Proteo's drug candidate Elafin for the treatment of esophagus carcinoma.

The details can be read here.

Neuromed Receives FDA Feedback on New Drug Application for Exalgo Extended-Release Tablets

Nov 16, 2009 - CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate EXALGOTM (hydromorphone HCl extended release) tablets, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA).

The details can be read here.

Human Genome Sciences Receives Complete Response Letter from FDA for Raxibacumab Biologics License Application

Nov 16, 2009 - Human Genome Sciences, Inc. today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company's Biologics License Application (BLA) requesting the approval of raxibacumab for use in the treatment of inhalational anthrax.

The details can be read here.

Xanodyne Announces FDA Approval of Lysteda (Tranexamic Acid) for Treatment of Women with Heavy Menstrual Bleeding

Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S. Food and Drug Administration (FDA) approval for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia.

the details can be read here.

NeurogesX Receives FDA Approval of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)

NeurogesX, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles. Qutenza delivers a synthetic form of capsaicin, the substance in chili peppers that gives them their heat sensation, through a dermal delivery system, providing up to 12 weeks of reduced pain following a single one-hour application. It is the first product from NeurogesX to be approved by the FDA.

The details can be read here.

Bioniche Pharma acquires Duraclon, Methadone HCl USP from Xanodyne

Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, announced the acquisition of Duraclon (clonidine hydrochloride injection) and Methadone Hydrochloride Injection USP from Xanodyne Pharmaceuticals, Inc.

The details can be read here.

New labelling rules for cosmetic products in D&C Act amendment to be enacted from 2010

The new labelling rules under the Drugs and Cosmetics (First Amendment) Rules, 2009, mandating cosmetic products to be labelled with its expiry date and prohibiting false or misleading claims in the label will be enacted by the beginning of 2010, as the government has failed to keep the time schedule fixed earlier to implement the rules, it is learnt.

the details can be read here.

Pharmacy students excluded from GATE from next year, 30,000 students in trouble

More than 30,000 pharmacy students in the country have been left in the lurch as they have been denied the opportunity to appear for the prestigious and much valued nationwide GATE (graduate aptitude test for engineering) exams by the national coordinating board (NCB) for GATE, which conducts the exams. The NCB has decided to exclude the pharmacy education from the purview of this nation-wide annual examination from next year.

the details can be read here.

Nuvo Research, Ranbaxy signs deal to market Oxoferin in Asian countries

The Canada-based transdermal drug development firm Nuvo Research Inc and Daiichi-Ranbaxy, the Indian subsidiary of Japanese drug major Daiichi Sankyo has entered into an exclusive license agreement for the supply and distribution of Oxoferin, a topical wound healing agent in some Asian countries.


The details can be read here.

Tamil Nadu to introduce Hib vaccine in immunization programme from next year

The Tamil Nadu government will introduce Hib (Haemophilus influenza type b) vaccine in the state's immunization programme from next year. The state health department is likely to make an announcement in the this regard by the end of this month, said Dr V Kanagasabai, Dean, Kilpauk Medical College, Chennai.


The details can be read here.

Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.


the details can be read here.

Ipsen's Decapeptyl 6-Month Formulation Receives Marketing Authorization in France

Ipsen (Paris:IPN), an innovation-driven global specialty pharmaceutical Group announces that the French regulatory authorities have today granted the marketing authorization to the 6-month sustained-release formulation of Decapeptyl® (triptorelin embonate1 22.5 mg) for the treatment of locally advanced and metastatic prostate cancer. The launch of the 6-month formulation of Decapeptyl® in France by Ipsen should take place during the first semester of 2010.

the details can be read here.

Bioniche Pharma Acquires Duraclon (clonidine hydrochloride injection) and Methadone Hydrochloride Injection USP

Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, announced today the acquisition of Duraclon® (clonidine hydrochloride injection) and Methadone Hydrochloride Injection USP from Xanodyne Pharmaceuticals, Inc.

The details can be read here.

LecTec Corporation and Endo Pharmaceuticals Inc. Settle Patent Dispute

Nov 11, 2009 - LecTec Corporation announced today that it has reached a settlement with Endo Pharmaceuticals Inc. on outstanding patent litigation related to LecTec's U.S. Patent Nos. 5,536,263 and 5,741,510. Endo Pharmaceuticals has agreed to make a one–time, $23 million payment for the exclusive license to these two patents for use in the field of prescription pain medicines and treatment.

the details can be read here.

Astellas Pharma set to launch Prograf in India, works on marketing strategy

Astellas Pharma India Pvt Ltd, the Indian subsidiary of the Japan's second largest drug major, Astellas Pharma, is working on a marketing strategy of spreading public awareness on organ transplantation and cadever organ donation along with intensive campaign among specialists to establish a market for its flagship immunosuppressant product - Prograf - in the country.

The details can be read here.

Roxane Laboratories, Inc. Announces the Launch of Perindopril Erbumine Tablets

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Perindopril Erbumine Tablets, 2mg, 4mg and 8mg by the U.S. Food and Drug Administration. The product is available in bottles of 100 for immediate shipment to wholesalers and pharmacies nationwide.

The details can be read here.

Industry may move court against DCGI's practice of including old drugs in New Drugs List

After getting stay orders on the issues of FDC and CoPP, the pharma industry may once again move court for another stay, this time the industry is contemplating to move court against the DCGI Dr Surinder Singh's practice of including several old drugs in the New Drugs List which prevents the manufacturers from getting licences from the state drug authorities.

The details can be read here.

US FDA Approves GSK’s Pandemic H1N1 Vaccine

GlaxoSmithKline (GSK) today announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for its unadjuvanted influenza A (H1N1) pandemic vaccine.

The details can be read here.

Teva Receives Favorable Court Decision Regarding Generic Prevacid SoluTab

Nov 10, 2009 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Takeda Pharmaceuticals North America, Inc.'s Prevacid® (Lansoprazole) SoluTab. The Court found that Teva's generic lansoprazole orally disintegrating tablets do not infringe U.S. Patent No. 5,464,632.

the details can be read here.

Roxane Laboratories, Inc. Announces the Launch of Perindopril Erbumine Tablets

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Perindopril Erbumine Tablets, 2mg, 4mg and 8mg by the U.S. Food and Drug Administration. The product is available in bottles of 100 for immediate shipment to wholesalers and pharmacies nationwide.

The details can be read here.

Microbix Receives Approval To Market Thrombolytic Agent Kinlytic (urokinase) In Canada

Nov. 10 -- Microbix Biosystems Inc. (MBX:TSX) today announced that KINLYTIC (urokinase for injection) has been approved in Canada for marketing and export. Health Canada's issuance of a Drug Identification Number for KINLYTIC gives Microbix the opportunity to market the product in Canada and export the clot-busting therapy to markets worldwide.

The details can be read here.

Teva Files Amended Complaint Against Momenta/Sandoz to Include Infringement of Three Copaxone-Related Patents

Nov 10, 2009 - Teva Pharmaceutical Industries Ltd. announced today it is seeking to amend its existing complaint against Momenta Pharmaceuticals, Inc./Sandoz Inc. to include patent infringement of three additional patents related to the characterization of COPAXONE® (glatiramer acetate injection).

The details can be read here.

Teva Receives Final Approval for Generic Prevacid Delayed-Release Capsules

Nov 10, 2009 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Tap Pharmaceutical's proton pump inhibitor Prevacid® (lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg. Customers will begin receiving product on November 11, 2009.

The details can be read here.

US FDA approves NDA for Pennsaid Topical Solution

Covidien, a leading global provider of healthcare products, and Nuvo Research Inc, a Canadian drug development company, announced that the US Food and Drug Administration (FDA) has approved the New Drug Application for Pennsaid Topical Solution (diclofenac sodium topical solution) 1.5% w/w.

The details can be read here.

Anti-Malignancy Agent Avastin Obtained Approval for Additional Indication of Non-Small Cell Lung Cancer

November 9, 2009 - Chugai Pharmaceutical Co., Ltd. announced today that it obtained approval by the Ministry of Health, Labour and Welfare (MHLW) on 6 November for the additional indication of "Unresectable advanced or recurrent non-squamous non-small cell lung cancer" of its anti-VEGF human monoclonal antibody bevacizumab (genetic recombination).

The details can be read here.

Intuniv Now Available in US Pharmacies

November 9, 2009 – Shire plc, the global specialty biopharmaceutical company, today announced the availability of INTUNIV™ (guanfacine) Extended Release Tablets in pharmacies across the United States for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17.

The details can be read here.

Generic Pharmaceutical Partner Jay Deshmukh Joins Knobbe Martens D.C. Office

Nov 9, 2009 - Jay R. Deshmukh has joined Knobbe Martens Olson & Bear, LLP as a partner in the firm's Washington D.C. office. He will focus his practice on generic pharmaceutical counseling and litigation.

The details can be read here.

FDA Approves Labeling Update for Reyataz (atazanavir sulfate) Capsules to Include 96-Week Data for Previously Untreated HIV-1 Infected Adult Patients

Nov 5, 2009 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved a labeling update for REYATAZ® to include long-term data from the CASTLE Study. The CASTLE Study assessed a once-daily REYATAZ/ritonavir (REYATAZ/r)-based regimen versus a twice-daily lopinavir/ritonavir (LPV/r)-based regimen in previously untreated adult patients infected with HIV-1. Data from the study demonstrate enduring virologic response through 96 weeks of treatment with REYATAZ/r as part of combination therapy.

The details can be read here.

FDA Approves Gloucester Pharmaceuticals' Istodax for Patients with Cutaneous T-cell Lymphoma

Nov 5, 2009 - Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The approval of ISTODAX was based on objective disease response defined as the proportion of patients with confirmed complete response or partial response.

The details can be read here.

Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Acular Ophthalmic Solution

Caraco Pharmaceutical Laboratories, Ltd. has launched ketorolac tromethamine ophthalmic solution, 0.5% following a final approval from the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA) for generic Acular® opthalmic solution on the first day following patent expiration.

The details can be read here.

Indian drug cos need to focus on niche segments in US generic market: Pharmexcil Study

The Indian pharma companies should focus more on complex chemistry, biotech-based medicines and advance formulations to tap the lucrative US generic market in future, suggests a study conducted by Pharmaceuticals Exports Promotion Council (Pharmexcil) – the apex body governing pharma exports under the Union Ministry of Commerce.

The details can be read here.

DCGI asks DTAB to re-examine many widely marketed drugs including Nimesulide

Several controversial drugs, which are banned in the developed nations like US, Canada and European Union nations for adverse health effects and are freely available in India, will be re-examined by the Drugs Technical Advisory Board (DTAB) in its meeting on November 9.

The details can be read here.

Sunesis' Voreloxin Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia

Sunesis Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML). Sunesis is currently conducting two Phase 2 clinical trials of voreloxin in AML: a single-agent study, known as REVEAL-1, of voreloxin in newly diagnosed elderly AML patients unlikely to benefit from standard induction chemotherapy and a study evaluating voreloxin in combination with cytarabine in relapsed/refractory AML.

The details can be read here.

ABRAXANE Receives Orphan Drug Status for the Treatment of Pancreatic Cancer and Stage IIB-IV Melanoma

Nov 5, 2009 - Abraxis BioScience, Inc., a fully integrated biotechnology company, today announced that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation to the chemotherapy agent ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of pancreatic cancer as well as stage IIB-IV melanoma.

The details can be read here.

Theratechnologies' NDA for Tesamorelin to be Reviewed by an FDA Advisory Committee

November 5, 2009 – Theratechnologies today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (“FDA”) will review Theratechnologies’ NDA for tesamorelin in the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.

the details can be read here.

NovaDel Receives Notice of Allowance for New U.S. Patent Covering its Oral Spray Drug Delivery Technology

Nov 5, 2009 - NovaDel Pharma Inc., today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. Patent Application No. 10/671,715, entitled “Buccal, Polar and Non-polar Spray Containing Zolpidem,” which covers a method of treating insomnia by administering zolpidem to humans utilizing NovaMist™ Oral Spray spray technology.

The details can be read here.

Purdue & Napp Pharma file patent infringement case against Cipher for CIP-Tramadoler

Cipher Pharmaceuticals Inc announced that Purdue Pharma Products LP and Napp Pharmaceutical Group Ltd have filed a complaint against Cipher in the United States District Court for the Eastern District of Virginia, for alleged infringement of two US patents. The action relates to Cipher's New Drug Application (NDA) filed with the US Food and Drug Administration (FDA) for CIP Tramadol, the company's extended-release tramadol product.

The details can be read here.

Abbott completes acquisition of Evalve

Abbott has completed its acquisition of Evalve, Inc, the global leader in the development of devices for minimally invasive repair of mitral valves.

The details can be read here.

InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF

Nov. 4 -- InterMune, Inc. today announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.


The details can be read here.

BioCryst's Partner Shionogi Files for Peramivir Regulatory Approval in Japan

Nov. 4 -- BioCryst Pharmaceuticals, Inc. today announced that its partner, Shionogi & Co., Ltd. has filed a New Drug Application (NDA) in Japan to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza. As a consequence of this filing, BioCryst will receive a regulatory milestone payment of $7 million under its agreement with Shionogi.

The details can be read here.

FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease

November 4-- Shire plc, the global specialty biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.

The details can be read here.

Novo Nordisk Launches Improvised NovoSeven - A New Room Temperature Stable Formulation

4th November 2009: Novo Nordisk India, a leading diabetes care company, with a strong presence in haemostasis area, launched a new room temperature stable rFVIIa (NovoSeven®) formulation, for Hemophilia with inhibitors. NovoSeven® has proven to be effective in the treatment of bleeding in hemophilia patients who develop antibodies (inhibitor patients).

The details can be read here.

Warner Chilcott completes acquisition of P&G's branded prescription pharma business

Warner Chilcott plc has completed the acquisition of The Procter & Gamble Company's global branded prescription pharmaceutical business. The acquisition complements Warner Chilcott's existing presence in women's health care and adds new therapeutic and geographic markets.

the details can be read here.

Amylin Pharma, Takeda ink worldwide pact to co-develop & commercialize compounds for obesity

Amylin Pharmaceuticals, Inc and Takeda Pharmaceutical Company Limited have entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize pharmaceutical products for the treatment of obesity and related indications. The agreement includes products to be developed from Amylin's pipeline, including pramlintide/metreleptin and davalintide, which are compounds currently in phase-2 development for treatment of obesity.

The details can be read here.

FDA Approves New Salix Product Exclusively in Catalent's Zydis Fast Dissolve Technology

Nov 3, 2009 - Catalent Pharma Solutions, one of the leading advanced drug delivery technology providers to the pharmaceutical industry, announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Metozolv™ ODT (orally disintegrating tablets) metoclopramide HCL utilizing Catalent's Zydis® fast dissolve technology.

the details can be read here.

Salix Pharmaceuticals Secures Additional Intellecutual Property Relating to Rifaximin

Nov 3, 2009 - Salix Pharmaceuticals, Ltd. today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,612,199 (the ˜199 patent) entitled “Polymorphic Forms Alpha, Beta, and Gamma of Rifaximin”. The patent issued November 3, 2009 and provides protection until June 2024.

The details can be read here.

Teva Introduces Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets; An Alternative to Allegra-D 12 Hour Tablets

Nov 3, 2009 - Teva Pharmaceutical Industries Ltd. announced today the commercial launch of Fexofenadine Hydrochloride 60 mg and Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablets, the same as the sanofi-aventis U.S. allergy treatment Allegra-D® 12 Hour (fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg) Extended-Release Tablets.

The details can be read here.

DTAB panel on FDCs clears no product out of 30 gastro combinations

The DTAB sub-committee on FDC, which held its third meeting on October 30 to decide the fate of around 30 combinations falling in the category of gastro-intestinal drugs, did not approve a single product as the expert panel asked the industry to come out with more scientific data to prove these products' safety and efficacy.


The details can be read here.

Ipsen launches Dysport in US to treat cervical dystonia

Ipsen, an innovation-driven global specialty pharmaceutical group, announced that Dysport is now available in the United States for the treatment of cervical dystonia in adults. Dysport is the latest addition to the growing range of Ipsen’s drugs already available in North America, both in endocrinology with Somatuline Depot and Increlex, and in neurology, with Apokyn.

The details can be read here.

Byetta (exenatide) - Altered kidney function, including acute renal failure/renal insufficiency, in patients on Byetta

Nov. 2, 2009--FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The details can be read here.

GTx Receives Complete Response Letter from FDA for Toremifene 80 mg New Drug Application

Nov 2, 2009 - GTx, Inc. today announced that it has received a Complete Response Letter issued by the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).

The details can be read here.

Dendreon Completes Submission of Biologics License Application for PROVENGE

Dendreon Corporation today announced that it has completed the submission of the amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T), the Company's lead investigational product, to the U.S. Food and Drug Administration (FDA). Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

the details can be read here.

U.S. Food and Drug Administration Issues Complete Response Letter Regarding Pegintron for Malignant Melanoma

Schering-Plough Corp. announced today the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.

The details can be read here.

Canadian authorities grant product approval for Intercell?s Vaccine to prevent Japanese Encephalitis

October 30, 2009 – Intercell AG today announced that the Health Canada granted product approval for IXIARO®, the company?s vaccine to prevent Japanese Encephalitis (JE). This decision of the Canadian authorities represents another important milestone for the product?s global reach. Intercell?s vaccine to prevent Japanese Encephalitis has already been successfully approved and launched in the USA, Europe and Australia.

The details can be read here.

Byetta Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes

Oct. 30, 2009 -- Amylin Pharmaceuticals, Inc., and Eli Lilly and Company (NYSE:LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes.

The details can be read here.

Covidien Receives FDA Approval for Oral Transmucosal Fentanyl Citrate Product

Oct 30, 2009 - Covidien, a leading global provider of healthcare products, today announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII).

The details can be read here.

Impax Laboratories Confirms Patent Challenge Relating to TRICOR 48mg and 145mg Tablets

Oct 30, 2009 - Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICOR® (fenofibrate) tablets, 48 mg and 145 mg.

The details can be read here.

Regeneron Pharma receives marketing authorization from EU for rilonacept to treat CAPS

Regeneron Pharmaceuticals, Inc has received marketing authorization in the European Union for rilonacept, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older.

The details can be read here.

Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application

Transcept Pharmaceuticals announced today that the U.S. FDA issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The details can be read here.

DTAB to review Sun Pharma's drug, letrozole, for sub-fertility on Nov 9

The Drugs Technical Advisory Board (DTAB), the highest body under the Union Health Ministry on technical matters concerning the pharma industry in the country, will re-examine the controversial drug letrozole which is indicated for sub-fertility in young menstruating women in the country. The DTAB is meeting on November 9.


The details can be read here.

European Commission Grants Promedior's PRM-151 Orphan Drug Designation for the Prevention of Scarring Post Glaucoma Filtration Surgery

Oct 29, 2009 - Promedior, Inc., a leader in the development of novel therapeutics for the treatment of fibrotic diseases and tissue remodeling, announced today that the European Commission has granted Orphan Medicinal Product Designation to its lead drug candidate PRM-151 for use in the prevention of scarring post glaucoma filtration surgery.

The details can be read here.

Shire Secures European Wide Label Extension for Fosrenol in Chronic Kidney Disease

October 28-- Shire plc, the global specialty biopharmaceutical company, today announced it has received approval through the European Mutual Recognition Procedure for an extension to the current indication for FOSRENOL(R) (lanthanum carbonate), paving the way to make the non-calcium, non-resin phosphate binder available throughout the EU to control hyperphosphataemia in chronic kidney disease (CKD) patients who are not on dialysis with a serum phosphorus level greater than or equal to 1.78mmol/L (5.5mg/dL).

The details can be read here.

Novartis on track to deliver Influenza A (H1N1) vaccine for the US

October 29, 2009 - Novartis confirmed today that it has shipped over 7.5 million doses of Influenza A(H1N1)[1] vaccine ready to use and expects 25 to 30 million doses of unadjuvanted vaccine to become available in pre-filled syringes and multi-dose vials by the end of November. Smaller changes in delivery timelines and volumes can result out of the variability of the underlying biological production process.

The details can be read here.

Watson and Barr Settle Lawsuit Over Oxytrol

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that its subsidiary Watson Laboratories, Inc. has reached a settlement with Barr Laboratories, Inc. on outstanding patent litigation related to Watson's Oxytrol® (Oxybutynin Transdermal System, 3.9mg/24hr.) product.

The details can be read here.

AstraZeneca Withdraws Regulatory Submissions For Zactima (Vandetanib) In Combination With Chemotherapy For Advanced NSCLC

28 October 2009 - AstraZeneca announced today that it has withdrawn the regulatory submissions for the use of ZACTIMA (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the US FDA and the European Medicines Agency (EMEA). The applications were submitted to regulatory agencies in June 2009.

The details can be read here.

Novartis Biological Drug Ilaris Approved In EU To Treat Children And Adults With CAPS, A Rare Debilitating Auto-Inflammatory Disease

October 28, 2009 - The new biological medicine Ilaris® (canakinumab) has been approved in the European Union (EU) to treat adults and children as young as four years old with cryopyrin-associated periodic syndrome (CAPS), a rare life-long auto-inflammatory disease with debilitating symptoms and few treatment options

The details can be read here.

Sandoz filed for declaratory Judgement of Invalidity and non-infringement of patents listed for Caduet

As reported on Patentdocs Sandoz has filed for the Declaratory judgment of invalidity and non-infringement of U.S. Patent Nos. 6,126,971 ("Stable Oral CI-981 Formulation and Process for Preparing Same," issued October 3, 2000), 5,969,156 ("Crystalline [r- (R*,R*)]-2-(4-DFluorophenyl)-b,δ-Dihydroxy-5-(1-Methylethyl)-3-Phenyl-4-[(Phenylamino)Corbonyl]-1HPyrrole-1Heptanoic Acid Hemi Calcium Salt (Atorvastatin)," issued October 19, 1999), and 5,686,104 ("Stable Oral CI-981 Formulation and Process of Preparing Same," issued November 11, 1997) based on Sandoz's filing of an ANDA to manufacture a generic version of Pfizer's Caduet®.

The details can be read here.

The complaint can be read here.

New data shows patients more satisfied with liraglutide than exenatide

New data on patient treatment satisfaction from the LEAD 6 trial presented at the 20th World Diabetes Congress (International Diabetes Federation) shows that patients have higher overall treatment satisfaction with liraglutide than they do with exenatide.

The details can be read here.

Sinovac Biotech gets approval to distribute swine flu vaccine Panflu in Mexico

Sinovac Biotech Ltd, a leading developer and provider of vaccines in China, has received a Certificate of Approval from the Secretaria de Salud to distribute Panflu.1, its H1N1 pandemic influenza (swine flu) vaccine, in Mexico.

The details can be read here.

Allergan Announces Victory in Brimonidine Patent Infringement Case

Oct 24, 2009 - Allergan, Inc. announced today that the United States District Court for the District of Delaware ruled in favor of Allergan, Inc. in its patent infringement suit against Exela PharmSci, Inc., Exela PharmSci Pvt., Ltd., Apotex, Inc. and Apotex Corp. for seeking to market purported generic versions of Allergan's drugs ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15%. Specifically, after a trial in March of 2009, the Court ruled today that all five patents (U.S. Patent Nos. 6,627,210; 6,641,834; 6,673,337; 6,562,873; and 5,424,078) asserted by Allergan are valid and enforceable, that Apotex's proposed generic versions of ALPHAGAN® P 0.1% and 0.15% infringe each of the five patents, and that Exela's proposed generic version of ALPHAGAN® P 0.15% infringes U.S. Patent No. 6,641,834, which was the only patent asserted against it. Pursuant to the Hatch-Waxman Act, the United States Food and Drug Administration is required to delay approval of Defendants' proposed generic products until the last to expire of the infringed patents, which is 2022.

The details can be read here.

Movetis obtains EU authorisation for the commercialisation of Resolor (prucalopride)

October 23, 2009 - Movetis, the GI specialty pharmaceutical company based in Belgium, announces that it has obtained approval from the European Commission for the commercialisation of its lead product Resolor (prucalopride – a 1mg and 2mg once a day oral tablet) for the symptomatic treatment of chronic constipation (CC) in women in whom laxatives fail to provide adequate relief.

The details can be read here.

Sun Pharma loses patent battle against Forest Labs on Alzheimer’s drug

The Mumbai-based Sun Pharmaceuticals has agreed to stop manufacturing and marketing of its generic version of Namenda (memantine hydrochloride), the lucrative Alzheimer’s drug patented by Forest Laboratories with the resolving of the dispute between the two firms at the US District Court for the District of Delaware.

The details can be read here.

Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010

Oct 22, 2009 - Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its review of the New Drug Application (NDA) for Fampridine-SR to January 22, 2010.

The details can be read here.

FDA Approves New Use for Micardis in Cardiovascular Risk Reduction and Twynsta as New Combination Treatment for High Blood Pressure

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. FDA approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme (ACE) inhibitors.

The details can be read here.

DCGI to notify guidelines attached to Spurious Drugs Act to curb harassment of drug units

In a bid to curb the possible misuse of powers by drug inspectors under the newly amended Drugs & Cosmetics Act, the Drug Controller General of India has started initiatives to notify the guidelines attached to the Bill to avoid unnecessary harassment to genuine drug manufacturers by the drug inspectors.

The details can be read here.

FDA Issues Complete Response Letter for CorVue

Oct 21, 2009 - King Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for CorVue™ (binodenoson) for injection.

the details can be read here.

APP Pharmaceuticals Receives Approval for the First Generic Chlorothiazide Sodium for Injection, USP

APP Pharmaceuticals, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Chlorothiazide Sodium for Injection, USP. APP expects to launch Chlorothiazide Sodium for Injection, USP in the fourth quarter of 2009.

The details can be read here.

International public interest groups slam EU on double standards on drug laws

International public interest organizations have charged the European Union with adopting double standards vis-à-vis poor and developed countries, and blocking the access to essential medicines across the world, especially in the underdeveloped countries.

The details can be read here.

US FDA panel backs Acorda Therapeutics' MS drug Fampridine-SR

Acorda Therapeutics, Inc announced the US FDA Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use.

The details can be read here.

Apollo pharmacy chain gets DCGI nod for selling oseltamivir

Apollo Pharmacy, India's leading pharmacy network with over 1000 outlets across the country, has received license from the Drug Controller General of India for the retail sale of oseltamivir, a drug for the treatment of H1N1 Influenza.

The details can be read here.

Dexferrum (iron dextran injection): Risk of anaphylactic-type reactions, including fatalities, following parenteral administration of iron dextran

Oct. 16, 2009--American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum.

The details can be read here.

Winston Laboratories, Inc. Receives Notice of Non-Compliance in Canada for its New Drug Submission of CIVANEX to Treat Osteoarthritis

Oct 19, 2009 - Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. today announced that it has received a Notice of Non-compliance from the Therapeutics Drug Directorate, Health Canada for its New Drug Submission (NDS) for CIVANEX (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis.

The details can be read here.

Exclusive European Sublicensing Agreement Signed for Teijin-developed TMX-67 Gout Treatment

October 20, 2009 -- Teijin Pharma announced today the signing of an exclusive sublicense agreement for TMX-67 (febuxostat) between Ipsen of France, the European TMX-67 licensee, and the Menarini Group of Italy. Discovered and developed by Teijin Pharma, TMX-67 is a novel drug for the treatment of hyperuricemia in patients with gout, and is a strategic product for the expansion of the company's overseas businesses.

The details can be read here.

Ipsen Grants Menarini Exclusive European Licence Rights to Adenuric (Febuxostat), Its Novel Treatment for Chronic Hyperuricaemia in Gout

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced an agreement whereby Ipsen grants the Menarini Group the exclusive licence rights to Adenuric® (febuxostat) in 41 countries. Ipsen retains co-promotion rights for Adenuric® in France.

the details can be read here.

India to lodge complaint with WTO against seizure of drug exports at EU ports

The Indian government will soon file a complaint at the World Trade Organisation (WTO) against the European Union (EU) on the issue of seizure of Indian drug shipments at EU ports, as efforts at different international forums to find an amicable solution to the nagging issue did not bear fruits so far.

The details can be read here.

AstraZeneca Submits Marketing Authorisation Application to European Union for Vimovo

Oct. 16, 2009-AstraZeneca and POZEN Inc. today announced that they have submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for VIMOVO™ (enteric-coated naproxen/immediate release esomeprazole magnesium, formerly known as PN 400) tablets, a product under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated ulcers.

The details can be read here.

Talecris Biotherapeutics Receives FDA Approval for Prolastin-C

Talecris Biotherapeutics today received approval from the U.S. Food and Drug Administration for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of PROLASTIN® produced using advances in manufacturing technology.

The details can be read here.

FDA Approves Elitek (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer

Sanofi-aventis U.S. announced that the U.S. FDA has granted marketing approval for Elitek® (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

The details can be read here.

FDA approves Cervarix, GlaxoSmithKline’s cervical cancer vaccine

Oct. 16, 2009--GlaxoSmithKline (GSK) announced today that the U.S. FDA has approved CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

The details can be read here.

Symbicort Turbuhaler Approved for the Treatment of Adult Asthma in Japan

Oct. 16, 2009--AstraZeneca today announced that Symbicort Turbuhaler (budesonide/formoterol) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the maintenance treatment of bronchial asthma in patients aged 16 and over when a combination therapy of an inhaled steroid and a long-acting beta-2 agonist is necessary.

The details can be read here.

U.S. Food and Drug Administration Approves Crestor for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

AstraZeneca today announced the U.S. FDA approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

The details can be read here.

Court Imposes Record Fine and Forfeiture of $1.3 Billion for Pharmacia & Upjohn Company's Fraudulent Marketing of Bextra

PHARMACIA & UPJOHN COMPANY, INC., a subsidiary of Pfizer Inc. today was sentenced today in federal court for a felony violation of the Food, Drug & Cosmetic Act, for misbranding the drug, Bextra, with the intent to defraud or mislead.

The details can be read here.

Federal Circuit Court Hands Academic Inventors a Big Win – IP Advocate Founder Says Decision Affirms That Faculty Inventors, Own Their inventions

A recent Federal Circuit Court decision confirms that universities do not automatically have the right to claim ownership of a faculty researcher's federally funded invention. That's a critical distinction that could protect faculty inventors and students nationwide from being forced by universities to sign away the rights to their life's work, according to Dr. Renee Kaswan, inventor of the billion-dollar drug Restasis® and founder of the non-profit organization IPAdvocate.org.

The details can be read here.

Teva Comments on Mylan Paragraph IV Filing for Copaxone; Files Lawsuit against Generic Filer for Patent Infringement

Oct 16, 2009 - Teva Pharmaceutical Industries Ltd. commented today on the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva also announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the Southern District of New York.

the details can be read here.

Boehringer Ingelheim Receives Approval from the European Commission for Mirapexin/Sifrol Prolonged-release, Once Daily Tablet

14 October 2009 – Boehringer Ingelheim today announced that the Mirapexin®/Sifrol® (pramipexole) new prolonged-release, once daily tablet has been granted marketing authorisation by the European Commission in all EU/EEA*) countries for the treatment of early and advanced idiopathic Parkinson’s disease (PD). The approval was based on the submission of clinical trial results showing that the new formulation can offer an efficacy and safety profile comparable to the immediate release tablet taken three times daily.1-6

The details can be read here.

US Court rules Ranbaxy's generic valganciclovir does not infringe Roche's Valcyte patent

In a verdict on the patent litigation between Roche Palo Alto and the Daiichi-Ranbaxy on the former's patent rights with crystalline valganciclovir, the active ingredient in anti-viral drug Valcyte, the District Court of New Jersey has ruled that Ranbaxy's generic version does not infringe the patent even as Roche's patent on the product is valid.

The details can be read here.

Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax Sprinkle Capsules

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15 mg and 25 mg.

The details can be read here.

Pfizer Announces Settlement And License Agreement With Mylan Related To Vfend

Oct 14, 2009 - Pfizer Inc today announced that it has entered into an agreement with two subsidiaries of Mylan Inc. relating to a generic version of Vfend (voriconazole), an antifungal agent. The agreement is limited to the tablet form of Vfend and does not cover Pfizer's Vfend products for intravenous use or oral suspension.


The details can be read here.