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.