Abbott launches Xience Prime drug eluting stent in international markets

Abbott announced at the European Society of Cardiology Congress the widespread availability of its next-generation Xience Prime Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

The details can be read here.

Novartis challenges IPAB's Glivec patent rejection in the Supreme Court

The Swiss pharma major Novartis AG has filed a special leave petition with the Supreme Court of India against the of Intellectual Property Appellate Board (IPAB) decision to reject the company's plea for patenting its imatinib mesylate - the blood cancer drug Glivec - in the country.

The details can be read here.

FDA Approves Valcyte (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart/Kidney Transplant

Roche announced today that the U.S. FDA has approved Valcyte (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk of developing CMV disease.

The details can be read here.

DCGI to revise timeline for approvals, efforts on for speedy disposal of pending cases

The Drug Controller General of India's (DCGI's) office is reworking the timeline for approvals fixed in last July for disposal of various approval applications with the authority. The authority has also initiated efforts to streamline its approval process on the pending cases, on applications filed prior to January 1, 2009, for speedy disposal.


The details can be read here.

Lumavita's pentamycin gets Swiss marketing nod to treat infectious vaginitis

Lumavita AG, the Swiss biopharmaceutical company specializing in novel anti-infectives for women's health, announced its first product approval. Following notice of preliminary approval issued in March 2009, the Swiss regulatory authority has granted final marketing authorisation to Lumavita's proprietary prescription medication, pentamycin, for the treatment of all types of infectious vaginitis.


The details can be read here.

Several drugs banned in US, Europe freely marketed in India

Several drugs, banned for their serious side effects in developed nations like US, Canada and European Union, are freely available in the country. Though the list of such drugs is long, the latest among them is a combination drug of flupenthixol and melitracen, sold under the brand name of Deanxit.

The details can be read here.

Supreme Court dismisses Roche's plea on Terceva patent, orders High Court to expedite trial proceedings

The Supreme Court of India has dismissed the petition filed by the Swiss pharma major Hoffman La Roche, against the Delhi High Court's order on patent litigation on its anti-cancer drug Tarceva with the Mumbai-based Cipla Ltd, it is learnt.

The details can be read here.

Unichem Lab gets US FDA nod for clonidine HCl tabs

Unichem Laboratories, a Mumbai based Rs 725 crore plus pharma major has received US FDA approval for clonidine hydrochloride tablets. These tablets are a low dose potent and popular molecule in the anti-hypertensive category.

The details can be read here.

Aurobindo gets US & Swiss nod for two products

Aurobindo Pharma has received US FDA's final approval for Clindamycin Hydrochloride capsules USP 150mg (base) and 300mg. Similarly, Swissmedic, Government of Switzerland has approved the license of Cefepime APL for Injection 1g and 2g.

The details can be read here.

Neuland Lab begins peptides production, starts new High Potent API facility

Neuland Laboratories, a reliable global provider of APIs and other essential drug discovery and development support services today announced successfully commencement of manufacturing of peptides blocks by successfully commercializing the production of Fmoc Pseudoproline Dipeptides and other building blocks in India and the US subsidiary.


The details can be read here.

Govt under pressure to reconsider revised Mashelkar Committee report

In the light of the recent reports that Dr Mashelkar has misinterpreted Carlos Correa's, a patent expert of international repute, views to support its conclusions in the revised report, the central government is under pressure from the NGOs working on patent issues to reconsider its decision to accept the revised report of Mashelkar Committee.


The details can be read here.

Sagent Pharmaceuticals Announces Launch of Fluconazole Injection in Premix Ready-to-Use IV Bags

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has launched fluconazole injection in premix bags. IMS Health estimates that 2008 U.S. sales of fluconazole injection approximated $18 million.

The details can be read here.

Mylan Begins Marketing First Generic Version of BenzaClin Acne Treatment

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market 1% Clindamycin and 5% Benzoyl Peroxide Gel based on an agreement with licensing partner Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International.

The details can be read here.

Caraco Pharmaceutical Laboratories, Ltd. Announces Reversal of Summary Judgment in Ultracet(R) ANDA Patent Litigation

Caraco Pharmaceutical Laboratories, Ltd. announced today that a US Federal Circuit Court has reversed a portion of a previously decided summary judgment on ANDA Patent litigation between Ortho McNeil and Caraco regarding Ultracet .

The details can be read here.

The whole judgement can be read here.

Nanotherapeutics gets $30.9 mn NIAID contract to develop inhaled antiviral for prophylaxis & treatment of smallpox

Nanotherapeutics, Inc, has been awarded a $30.9 million, five-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop an inhaled version of the injectable antiviral drug, cidofovir, for non-invasive, post-exposure prophylaxis and treatment of the Category A bioterrorism agent smallpox (Variola major).


The details can be read here.

Shire enters research collaboration with Santaris Pharma on LNA drug platform

Shire plc, the global specialty biopharmaceutical company, has entered into a research-based collaboration with Santaris Pharma A/S, a leading player in RNA-based therapeutics, to develop its proprietary Locked Nucleic Acid (LNA) technology in a range of rare diseases, thereby enabling Shire to build on its already strong competitive position for its Human Genetic Therapies (HGT) business.

The details can be read here.

Endo Pharmaceuticals to Partner With ProStrakan to Commercialize Fortesta in the U.S.

Endo Pharmaceuticals today announced that it has signed an agreement with U.K.-based ProStrakan Group plc for the exclusive right to commercialize FORTESTA(TM) (testosterone gel) 2 percent in the United States.

The details can be read here.

Schering-Plough Announces Two European Filings

Schering-Plough Corporation, today announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years of age and older.

The details can be read here.

Antares Pharma Announces Launch of Tjet Needle-Free Injector System by Marketing Partner Teva

Aug 25, 2009 - Antares Pharma, Inc. today announced that its partner Teva Pharmaceutical Industries Ltd. has launched its new Tjet™ needle-free injector system for the administration of human growth hormone (hGH).

The details can be read here.

Warner Chilcott to acquire P&G's global pharma business for $3.1 billion

The Procter & Gamble Company and Warner Chilcott plc announced an agreement for the sale of P&G's global pharmaceuticals business to Warner Chilcott for an up-front cash payment of $3.1 billion.


The details can be read here.

DCGI survey finds no significant amount of spurious drugs in Indian pharma market

The Union Health Ministry's ambitious nationwide survey to get an authentic estimate of spurious drugs in the country found no significant amount of spurious drugs in the pharmaceutical market. Among the 24,000 samples collected by the government for the survey, only around 10 were found to be spurious, it is reliably learnt.

The details can be read here.

Cambrex Receives FDA Warning Letter

Cambrex Corporation announced that it has received a warning letter from the U.S. Food and Drug Administration relating to an inspection of the Company's generic active pharmaceutical ingredient manufacturing facility located in Milan, Italy in March 2009.

The details can be read here.

Protalix Receives FDA Fast Track Designation for prGCD

Aug 25, 2009 - Protalix BioTherapeutics, Inc., announced today that it has received Fast Track Designation from the U.S. FDA for prGCD, the Company's proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

The details can be read here.

US Department of Health and Human Services Grants Orphan Drug Status to BioCancell's Ovarian Cancer Drug

Aug 24, 2009 - Tikcro Technologies today announced that the United States (“US”) Department of Health and Human Services ("HHS") has granted orphan drug status to BioCancell's BC-819 drug, currently in Phase I/IIa clinical trials, for its use in treating ovarian cancer.

The details can be read here.

Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS

Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has confirmed that its Peripheral and Central Nervous System Drugs Advisory Committee will review the Company's NDA for Fampridine-SR on October 14, 2009.

The details can be read here.

Salix Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review Designation For Rifaximin NDA

Salix Pharmaceuticals, Ltd. today announced the FDA has accepted for filing and designated for Priority Review the Company's New Drug Application (NDA) for rifaximin tablets 550 mg for the maintenance of remission of hepatic encephalopathy (HE).

The details can be read here.

BioAlliance Pharma: Loramyc Obtains Marketing Authorization in Switzerland

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced that Loramyc® has obtained Marketing Authorization in Switzerland for the treatment of oropharyngeal candidiasis in immunocompromised patients (mainly cancer and AIDS patients with oral opportunistic infections).

The details can be read here.

Novartis receives approval in EU for Xolair to treat children age 6 to 11 years suffering from severe persistent allergic asthma

Novartis announced today that the European Commission (EC) has approved Xolair® (omalizumab) as add-on therapy for severe persistent allergic asthma in children age 6 to 11 years.

The details can be read here.

BioDelivery Sciences Announces Issuance of U.S. Patent Extending Exclusivity for the BEMA Delivery Technology

Aug 25, 2009 - BioDelivery Sciences International, Inc. today announced the issuance of United States Patent 7,579,019, which will provide additional patent exclusivity for both ONSOLIS™ and BDSI's BEMA® drug delivery technology platform until at least 2019.

The details can be read here.

Osteologix Receives Positive Decision to Grant a Patent for Key Osteoporosis Drug Patent in Japan

Aug 24, 2009 - Osteologix, Inc. today announced that the Japan Patent Office (JPO) has issued a Decision to Grant a Patent for Application Number 2006-504379: "Treating Cartilage/Bone Conditions with Water-Soluble Strontium Salts".

The details can be read here.

APP Pharmaceuticals Receives Approval for Penicillin G Potassium for Injection, USP

Aug 25, 2009 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. FDA to market penicillin G potassium for Injection, USP, in two dosage strengths.

The details can be read here.

Ortho-McNeil-Janssen gets US FDA complete response letter for carisbamate

The US Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for carisbamate, an anti-epileptic drug in development, announced Ortho-McNeil-Janssen Pharmaceuticals, Inc.

The details can be read here.

Ranbaxy gets US FDA nod for glycopyrrolate tabs to treat peptic ulcer

Ranbaxy Laboratories Limited (RLL), has received approval from the US Food and Drug Administration (US FDA) to manufacture and market glycopyrrolate tablets USP, 1 mg and 2 mg.

The details can be read here.

UCB Further Strengthens its Second Largest Market, Germany

UCB and Novartis announced today that they entered into a licensing agreement for cardiovascular and diabetes products in Germany. Under the agreement, UCB has extended commercial rights for the German market to the cardiovascular medication Provas® (valsartan) beyond 2011 and has licensed in commercial rights for two line extensions: Dafiro® (valsartan and amlodipine) and Dafiro HCT® (valsartan, amlodipine and HCT).

The details can be read here.

ARIAD And Its Co-Plaintiffs Announce That the Court of Appeals Granted Their Petition for Rehearing En Banc In the Lilly NF-kB Patent Lawsuit

Aug 24, 2009 - ARIAD Pharmaceuticals, Inc. and its co-plaintiffs today announced that the U.S. Court of Appeals for the Federal Circuit (the “Federal Circuit”) has granted their petition for rehearing en banc and has vacated its April 2009 decision in the appeal that Eli Lilly and Co. filed in 2008.

The details can be read here.

The order can be read here.

Aptar Pharma gears up to increase presence in India with a range of nasal & pulmonary devices

Aptar Pharma India Pvt Ltd, a drug delivery device major is gearing up to increase its market presence in the country with its range of pulmonary and nasal drug dispensing products.

The details can be read here.

Novartis drug Femara is superior to tamoxifen after breast cancer surgery: Study

Newly published data in The New England Journal of Medicine affirm five-year upfront use of Femara (letrozole) following surgery as an optimal treatment approach versus tamoxifen for postmenopausal women with early stage breast cancer (hormone-receptor positive).


The details can be read here.

The Medicines Company Withdraws European Marketing Application for 3-7 Day Daily Dose Oritavancin Therapy

The Medicines Company today announced the withdrawal of the European marketing authorization application (MAA) for the 200mg 3-7 day daily dose therapy of oritavancin, its investigational antibiotic drug candidate for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram positive pathogens.

The details can be read here.

FDA Accepts Drug Application for Miconazole Lauriad to Treat Oropharyngeal Candidiasis

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE:PRX) , today announced that the U.S. FDA has accepted the new drug application (NDA) for miconazole Lauriad mucoadhesive buccal tablets (MBT) to treat oropharyngeal candidiasis (OPC).

The details can be read here.

Lundbeck Inc. Announces FDA Marketing Approval for Sabril for the Treatment of Two Difficult-to-Treat Epilepsies

Aug 21, 2009 - Lundbeck Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark (Copenhagen: LUN), announced today that the U.S. Food and Drug Administration (FDA) has granted two New Drug Application (NDA) approvals for Sabril® (vigabatrin) Tablets and Oral Solution. Lundbeck plans to launch Sabril in the United States in the third quarter.

The details can be read here.

Anika Therapeutics Receives Health Canada Approval for MONOVISC

Anika Therapeutics, Inc., a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, today announced that it has received Health Canada approval for MONOVISC™, its single injection viscosupplement approved for the treatment of osteoarthritis of the knee.

The details can be read here.

FDA Approves GSK's Hib Vaccine, Hiberix

In response to a U.S. shortage of a vaccine to protect infants from Haemophilus influenzae type b (Hib), GlaxoSmithKline has received accelerated approval from the FDA (Food and Drug Administration) for Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] as a booster dose in children 15 months through four years of age.

The details can be read here.

Takeda Reacquires Rights to Leading Diabetes Drug in Canada

Takeda Canada, Inc. announced that it has reacquired the Canadian commercial rights to ACTOS(R) (pioglitazone HCl), an oral treatment for type 2 diabetes, from Eli Lilly Canada Inc. Takeda, the discoverer of ACTOS, licensed the drug to Lilly as part of a worldwide agreement in 1999. "Reacquiring the commercial rights to ACTOS is Takeda's first opportunity to establish a commercial presence in Canada," said Daaron Dohler, general manager at Takeda Canada.

The details can be read here.

MultiCell Technologies is Granted U.S. Patent for Immortalized Human Liver Cell Lines

MultiCell Technologies, Inc. announced today it has been granted U.S. patent 7,566,567 by the United States of America Patent and Trademark Office covering its Fa2N-4 and Ea1C-35 immortalized human hepatocyte cell lines.

The details can be read here.

Forty-two of Simcere's Generic Drugs Enter China's Essential Drug List

Simcere, a leading manufacturer and supplier of branded generic and innovative pharmaceuticals in China, today announced that forty-two of its generic drugs have been included in China's Essential Drug List, which was issued by China's Ministry of Health ("MOH") on August 18, 2009.

The details can be read here.

Unichem Labs gets US FDA nod for bisoprolol fumarate tabs

Unichem Laboratories Ltd, a Rs 725 crore plus pharma company, has received US FDA approval for bisoprolol fumarate tablets USP, 5mg and 10mg.


The details can be read here.

Roche's Avastin in combo with chemotherapies meets primary endpoint in phase-3 study

Roche announced that a phase-III study of Avastin (bevacizumab) in combination with a range of chemotherapies met its primary endpoint of increasing the time women with previously treated advanced HER2 negative breast cancer lived without the disease getting worse (progression-free survival or PFS) compared to chemotherapy alone.

The details can be read here.

Glenmark, Forest Lab's COPD drug Oglemilast fails in phase IIb study

Glenmark Pharmaceuticals S.A., a subsidiary of Glenmark Pharmaceuticals India (GPL) and Forest Laboratories, Inc have announced that the top-line results from a phase IIb dose range finding study of Oglemilast in patients with Chronic Obstructive Pulmonary Disease (COPD) failed to generate positive results and they are taking further action.


The details can be read here.

Panacea Biotec bags USD 222 mn UNICEF order for pentavalen vaccine

Panacea Biotec, India's second largest biotechnology company and WHO pre-qualified vaccine major, has received an award notification for supply of its EasyFive (pentavalent vaccine) worth US$222.37 million (Rs 1,067 crore), from UNICEF for years 2010, 2011 and 2012.

The details can be read here.

Basilea Pharmaceutica Ltd. (CH) - FDA Issues Warning Letter to Johnson & Johnson Related to Ceftobiprole

August 18, 2009 - Basilea Pharmaceutica Ltd. announces that the company was notified today that the U.S. FDA issued to Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) a Warning Letter related to clinical trials for ceftobiprole for the treatment of complicated skin and skin structure infections.

The details can be read here.

FDA Accepts Drug Application for Miconazole Lauriad to Treat Oropharyngeal Candidiasis

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad mucoadhesive buccal tablets (MBT) to treat oropharyngeal candidiasis (OPC).

The details can be read here.

Merck Wins Singulair Patent Infringement Lawsuit

Merck & Co., Inc. announced today that the U.S. District Court for the District of New Jersey has ruled in Merck's favor in a patent infringement suit against Teva Pharmaceuticals USA Inc. (Teva). Teva was seeking FDA approval to sell a generic version of 4, 5 and 10 mg tablets of SINGULAIR (montelukast sodium), Merck's asthma and allergic rhinitis medicine.

The details can be read here.

The whole judgement can be read here.

The order can be read here.

Par Pharmaceutical & Aveva Drug Delivery Systems Receive Final Approval to Market Generic Catapres TTS

August 18, 2009 -- Par Pharmaceutical Companies, Inc. today announced that its licensing partner, Aveva Drug Delivery Systems, has received final approval from the U.S. FDA for its ANDA for a clonidine transdermal system.

the details can be read here.

Mylan's Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla HIV Treatment

Mylan Inc. today announced that Matrix Laboratories, an Indian company in which Mylan owns a controlling stake, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for a fixed-dose combination (FDC) of Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Tablets, 600 mg/200 mg/300 mg.

The details can be read here.

Delhi High Court dismisses Bayer's plea for patent linkage

In a landmark judgment on Tuesday, the Delhi High Court dismissed Bayer Corporation's Writ Petition to sanction the patent linkage system in India through a court direction.

The details can be read here.

GSK files patent infringement lawsuit against Glenmark on atovaquone & proguanil HCl tabs

Glenmark Generics Ltd confirmed that Smithkline Beecham Corporation filed a patent infringement lawsuit on their US subsidiary, Glenmark Generics Inc, USA in the US District Court for the District of Delaware in connection with the Abbreviated New Drug Application filing for atovaquone and proguanil hydrochloride 250mg/100mg tablets.

The details can be read here.

Gloucester Pharmaceuticals Announces FDA Advisory Committee Meeting to Discuss Romidepsin New Drug Application

Aug 17, 2009 - Gloucester Pharmaceuticals will discuss the New Drug Application for romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL) at the Oncologic Drugs Advisory Committee (ODAC) meeting on September 2, 2009.

The details can be read here.

Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A

CSL Behring announced today that Helixate® FS, Antihemophilic Factor (Recombinant), has been approved by the U.S. FDA for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage.

The details can be read here.

Orexo announces that its partner Meda has initiated the launch of EdluarTM (Zolpidem) in the USA

Orexo confirms that Meda has initiated the launch the drug EdluarTM in the United States of America. The launch follows the US Food and Drug Administration's (FDA) approval in March this year of EdluarTM 5 mg and 10 mg sublingual tablets for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

The details can be read here.

Labopharm comments on judgment in Purdue patent litigation

Labopharm Inc. today commented on the outcome of patent-infringement litigation initiated by Purdue Pharma Products L.P. against Par Pharmaceutical Companies, Inc. relating to Ultram(R) ER (tramadol hydrochloride extended-release tablets).

The details can be read here.

U.S. District Court Rules Against Lilly Regarding Gemzar Patent

Eli Lilly and Company today announced that the U.S. District Court for the Eastern District of Michigan has granted a motion by Sun Pharmaceuticals for partial summary judgment. The Court's ruling invalidates Lilly's '826 patent, or method-of-use patent, for Gemzar (gemcitabine HCl for injection) which had been set to expire in 2013.

The details can be read here.

Tianyin Pharma gets Chinese nod for Snaqi & Yinqiao Jiedu tabs

Tianyin Pharmaceutical Co, Inc, a manufacturer and supplier of modernized traditional Chinese medicine (TCM) based in Chengdu, China, has received approvals from the Chinese State Food and Drug Administration (SFDA) to produce Sanqi tablets in dosage form of 0.5 gram/tablet (SFDA approval number Z20093512) and Yinqiao Jiedu tablets in dosage form of 0.5 gram/tablet (SFDA approval number Z20093555).


The details can be read here.

Super Religare Labs ready for swine flu screening

Super Religare Laboratories (SRL), India's largest diagnostics network, is fully prepared for a fight against the increasing number of swine flu cases in the country. SRL has ensured adequate availability of kits at its two reference laboratories in Mumbai and Gurgaon, both of which are accredited by CAP (College of American pathologist), USA and the National Accreditation Board for Laboratories (NABL), Govt. of India.

The details can be read here.

FDA MedWatch - CellCept (mycophenolate mofetil) - cases of Pure Red Cell Aplasia reported in patients treated with CellCept

Roche notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. The WARNINGS and ADVERSE REACTIONS sections of the CellCept Prescribing Information have been revised to reflect this new safety information.

The details can be read here.

US FDA Approves Extavia

August 17, 2009 - The US FDA has approved Extavia® (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease.


The details can be read here.

Biovail Comments on Ultram ER Court Ruling

Aug 17, 2009 - Biovail Corporation announced today that on August 14, 2009, in the United States District Court for the District of Delaware, Judge Kent A. Jordan issued an opinion in favour of Par Pharmaceuticals, Inc. (Par) in the patent-infringement litigation relating to Ultram® ER (tramadol hydrochloride extended-release tablets). Although Biovail is not a party to the action, the decision could have an effect on Biovail's revenues relating to Ultram® ER.

The details can be read here.

Merck sued over patent on allergy drug Singulair (montelukast)

The battle over the patent on Merck and Co.'s allergy and asthma drug Singulair, the best-selling drug of one of the world's largest drug makers, continued Friday as a group of drug distributors and health insurers sued Merck.


The details can be read here.

NuPathe gets top-line results of Zelrix's phase-III trial in acute migraine

NuPathe Inc, a specialty pharmaceutical company developing innovative products for the treatment of neurological and psychiatric diseases, announced top-line results from the pivotal phase-III clinical trial of Zelrix, a novel transdermal patch in clinical development for the treatment of acute migraine.

The details can be read here.

Javelin Pharma gets top-line result from phase-III study of Ereska in postoperative orthopaedic pain

Javelin Pharmaceuticals, Inc described its initial review of top line results from a phase-III study of Ereska (intranasal ketamine 30mg). This randomized, multicenter, double-blind, 1:1 placebo-controlled study assessed the safety and analgesic efficacy of repeated doses of Ereska over six hours in 259 patients with acute moderate-to-severe pain following orthopaedic surgery

The details can be read here.

NGOs ask govt to reject Mashelkar Committee recommendations on patent

NGOs working on patent issues in the country have asked the government to reject the recommendations of the Mashelkar Committee on the twin issues of 'evergreening of patents' and 'excluding micro-organism from patentability'.

The details can be read here.

Schering-Plough Announces FDA Approval of Saphris (asenapine

Schering-Plough Corporation today announced that the U.S. FDA has approved SAPHRIS (asenapine) sublingual tablets for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.

The details can be read here.

India has access only to Tamiflu for swine flu treatment

Tamiflu (oseltamivir) and Relenza (zanamivir) are the two drugs prescribed to treat swine flu caused by the H1N1 virus. But India has access only to Tamiflu (oseltamivir), though the mode of action for both the drugs is to block the viral receptors infecting the healthy cells.

The details can be read here.

US FDA to review Allos Therapeutics' pralatrexate NDA

Allos Therapeutics, Inc has received notification from the US Food and Drug Administration (FDA) that the Oncologic Drugs Advisory Committee (ODAC) will hold a meeting on September 2, 2009, to review the company's New Drug Application (NDA) for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

The details can be read here.

Tentative approval of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate

On August 12, 2009, FDA granted tentative approval for a generic fixed dose combination product containing efavirenz/emtricitabine/fenofovir disoproxil fumarate 600 mg/200 mg/300 mg manufactured by Matrix Laboratories Limited of Hyberdad, India.

The details can be read here.

Mylan Pharmaceuticals Receives Final FDA Report and Reaffirms Its 48-Year Exemplary Record of Quality

Mylan Inc. today announced that the U.S. FDA has released its official and final report regarding the agency's review of allegations made in a July newspaper article concerning the company's Morgantown, W.Va., manufacturing facility. The newspaper article, which included unfounded and highly inaccurate allegations, was based on improperly obtained documents, uninformed third-party commentary and anonymous sources. The final FDA report closes the inspection with no deficiencies found and no FDA "483" issued.

The details can be read here.

FDA Approves Embeda For Management of Moderate to Severe Chronic Pain

King Pharmaceuticals , Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

The details can be read here.

Health Canada Approves Multaq - First new atrial fibrillation treatment in 20 years

August 12, 2009 – Sanofi-aventis Canada announced today that Multaq (dronedarone, 400 mg tablets) has received Health Canada approval for the treatment of patients with a history of, or current atrial fibrillation to reduce their risk of cardiovascular hospitalization due to this condition.

The details can be read here.

U.S. Food And Drug Administration Has Accepted To File Theratechnologies' New Drug Application

Theratechnologies today announced that the US Food and Drug Administration has accepted to file the New Drug Application made by the Company for its lead compound, tesamorelin.

The details can be read here.

Schering-Plough Announces Resolution of Litigations on U.S. Marketing of Generic Forms of Solid Oral Dosage Forms of Clarinex

Schering-Plough Corporation today announced an agreement with Orchid Chemicals & Pharmaceuticals Ltd. and Orgenus Pharma, Inc., related to the generic manufacturing of certain formulations of CLARINEX (desloratadine).

The details can be read here.

Strides Arcolab geared to meet demand for oseltamivir capsules to treat swine flu

Strides Arcolab which is one of the qualified suppliers of drugs for H1N1 virus is ready with supplies of 'oseltamivir capsules' - the generic equivalent of Tamiflu. It is currently awaiting the orders from government of India to supply the drug.


The details can be read here.

US FDA nod for Aurobindo's sumatriptan succinate tabs

Aurobindo Pharma has received final approval for sumatriptan succinate tablets 25 mg, 50 mg and 100 mg from US FDA. These tablets are the generic equivalent of GlaxoSmithKline's Imitrex tablets and are indicated for the treatment for acute migraine headaches and falls under the CNS therapeutic segment.

the details can be read here.

ProStrakan seeks US FDA approval for cancer pain drug Abstral

Orexo AB announced that its partner, UK-based international specialty pharmaceutical company ProStrakan Group plc, has submitted the New Drug Application (NDA) for Abstral (for the treatment of breakthrough cancer pain in opioid-tolerant patients) to the US Food and Drug Administration (FDA).


The details can be read here.

Ranbaxy gets US FDA approval for Sumatriptan Succinate tabs

Ranbaxy Laboratories has received final approval from the US FDA to manufacture and market Sumatriptan Succinate tablets 25 mg, and 50 mg. These tablets are the generic equivalent of GlaxoSmithKline's Imitrex tablets.

The details can be read here.

Astellas Seeks Rigorous Testing and Safety-Related Labeling for Anti-Rejection Medications

Astellas Pharma US, Inc. announced today that the U.S. FDA has substantially denied the company's Citizen Petition to ensure the safe and effective use of immunosuppressants used to prevent rejection in organ transplant patients.

The details can be read here.

Sepracor Announces New Drug Submission (NDS) to Health Canada for STEDESA as Adjunctive Treatment for Epilepsy

Aug 10, 2009 - Sepracor Inc. today announced that its Canadian subsidiary, Sepracor Pharmaceuticals, Inc., has submitted an application to the Therapeutic Products Directorate (TPD) of Health Canada for eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.

The details can be read here.

APP Pharmaceuticals Receives Approval for Idarubicin HCI Injection

Aug 10, 2009 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. FDA to market idarubicin hydrochloride injection in three dosage strengths (5mg/5mL, 10mg/10mL and 20mg/20mL).

the details can be read here.

Tracleer receives label extension in the US for the treatment of patients with mildly symptomatic WHO Functional Class II PAH

10 August 2009 - Actelion Ltd announced today that the U.S. FDA has approved the company's supplemental New Drug Application (sNDA) for Tracleer® (bosentan) to treat patients with mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH).

The details can be read here.

Teva Announces Approval and Launch of Oxaliplatin Injection

Aug 11, 2009 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced U.S. Food and Drug Administration (FDA) approval and launch of Oxaliplatin Injection.

The details can be read here.

Statement on Fosamax (alendronate sodium) Product Liability Trial in U.S. District Court

Merck & Co., Inc. will vigorously defend itself in a jury trial set to begin today, in the United States District Court for the Southern District of New York.

The details can be read here.

Novartis International AG (CH) - Sandoz Launches First Generic Version of Prograf Capsules

August 11, 2009 - Sandoz today announced the introduction of tacrolimus capsules, a generic equivalent of Prograf®, in the US. Tacrolimus is an immunosuppressive treatment used to help prevent rejection of a kidney or liver transplant.

The details can be read here.

Nigeria assures India to keep patent issues out of counterfeit legislation

Even as many African countries are in the process to enact anti-counterfeit acts which may harm the generic exports from India, Nigeria has assured Indian pharma industry and government officials that it would exclude patent issues and generic drugs from the definition of counterfeit medicines.

The details can be read here.

Abstral file submitted to the FDA for approval in the USA

August 6, 2009 - Orexo AB today announces that its partner, UK-based international specialty pharmaceutical company ProStrakan Group plc, has submitted the New Drug Application (NDA) for Abstral™ (rapinyl)(for the treatment of breakthrough cancer pain in opioid-tolerant patients) to the US FDA.

the details can be read here.

Afinitor Approved in EU as First Treatment Proven to Benefit Patients With Advanced Kidney Cancer After Failure of Targeted Therapy

August 6, 2009 - The European Commission (EC) has approved Afinitor® (everolimus) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.

The details can be read here.

Perrigo Announces FDA Approval for Generic Version of NASACORT AQ

Perrigo Company today announced that its partner Teva Pharmaceutical Industries Ltd. has received final approval from the U.S. FDA to market Triamcinolone Acetonide Nasal Spray containing a paragraph IV certification.

the details can be read here.

Impax Laboratories Receives Final FDA Approval for Generic Depakote Extended-Release 500mg Tablets

Aug 5, 2009 - Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic version of Depakote® (divalproex ER) 500mg Extended-release Tablets.

The details can be read here.

Teva Announces Appeals Court Ruling Affirming Invalidation of Yasmin Patent

Aug 5, 2009 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a ruling by the U.S. District Court for the District of New Jersey finding Bayer Schering's U.S. Patent No. 6,787,531 invalid.

The details can be read here.

The whole judgement can be read here.

MedWatch - Tumor Necrosis Factor (TNF) Blockers: Boxed Warning describing increased risk of lymphoma in children, adolescents treated with TNF blocker

Aug. 4, 2009--FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products.

The details can be read here.

Kamada's BLA for IV-AAT to Treat Alpha-1 Antitrypsin Deficiency is Accepted for Review by the US Food and Drug Administratio

Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that the United States Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for intravenous alpha-1 antitrypsin (IV-AAT), the Company's flagship product for the treatment of alpha-1 antitrypsin deficiency.

The details can be read here.

New Delivery System for RELISTOR in Pre-Filled Syringes Submitted for U.S. and European Marketing Approval

Aug 4, 2009 - Progenics Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, today announced submission of a supplemental New Drug Application (sNDA) to the U.S.FDA and an Extension Application to the European Union (E.U.) European Medicines Agency (EMEA) for RELISTOR® (methylnaltrexone bromide) subcutaneous injection for a new delivery system, pre-filled syringes.

The details can be read here.

FDA Approves Livalo for Primary Hypercholesterolemia and Combined Dyslipidemia

Kowa Research Institute based in Morrisville, NC and Kowa Pharmaceuticals America, Inc., a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. FDA has approved LIVALO (pitavastatin), a potent HMG-CoA reductase inhibitor (statin), for the primary treatment of hypercholesterolemia and combined dyslipidemia.

the details can be read here.

Elan Drug Technologies Announces First Approval of a Long Acting Injectable Formulation Using NanoCrystal Technology

Aug 3, 2009 - Elan Drug Technologies, a business unit of Elan Corporation, plc announces the first approval of a long-acting injectable formulation using Elan Drug Technologies' proprietary NanoCrystal® technology.

the details can be read here.

The US FDA Approves Lipsovir for Marketing and Sales in US

Aug. 3, 2009--The US FDA has now approved Lipsovir®, i.e. granted Medivir’s New Drug Application (NDA) for the use of acyclovir and hydrocortisone for early treatment of recurrent cold sores to decreases the risk of cold sores, and to shorten the healing time for those cold sores which are not prevented.

The details can be read here.

Zogenix and Astellas Enter Exclusive Co-Promotion Agreement in the US for Newly Approved Sumavel DosePro

Zogenix, Inc., a privately held pharmaceutical company and Astellas Pharma US, Inc., announced today their exclusive co-promotion agreement for Sumavel DosePro (sumatriptan injection) needle-free delivery system. Sumavel DosePro received FDA approval in July 2009 and is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients.

The details can be read here.

Sun Pharma signs agreement with MedImmune for generic Ethyol

August 3, 2009 - Sun Pharmaceutical Industries Ltd announced today that it has, along with its subsidiaries, executed a settlement agreement with MedImmune, stipulating the dismissal of the lawsuits filed in the United States District Court for the District of Maryland regarding the submission of an ANDA for a generic version of Ethyol®.

The details can be read here.

Warner Chilcott Announces Receipt of Paragraph IV Certification Notices

Warner Chilcott Limited announced today that it has received two Paragraph IV Certification Notices from Lupin Ltd. The Paragraph IV Certification Notices advise the Company of the filing of ANDAs by Lupin for generic versions of the Company's oral contraceptives, LOESTRIN 24 FE and FEMCON FE.

the details can be read here.

Watson Pharmaceuticals Receives FDA Approval for Generic Toprol XL 25 MG and 50 MG

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration on its Abbreviated New Drug Applications (ANDAs) for metoprolol succinate extended-release tablets USP in the 25 mg and 50 mg strengths. Metoprolol succinate extended-release tablets are the generic equivalent to AstraZeneca's Toprol XL tablets.

The details can be read here.

FDA Approves Avastin for the Most Common Type of Kidney Cancer

Aug 3, 2009 - Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved Avastin® (bevacizumab) plus interferon-alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer.

The details can be read here.

Nycomed to Acquire Local Portfolio from Sanofi-Aventis and Zentiva

Nycomed agreed with Sanofi-Aventis and Zentiva to purchase 20 branded generic products in several Central and Eastern European countries. In an asset transfer transaction, Nycomed will purchase a portfolio of branded generic products in the Czech Republic, Slovakia, Romania, Hungary, Estonia, and Bulgaria, with a total annual turnover of approximately € 17 million.

The details can be read here.

U.S. District Court Issues in Favor of Daiichi Sankyo Regarding Patent Litigation for Benicar, Benicar HCT and Azor

Daiichi Sankyo Company, Limited announced today that the U.S. District Court in New Jersey has issued a decision in our U.S. patent litigation against Mylan* upholding the validity of our patent covering the Benicar®, Benicar HCT® and AZOR® products.

The details can be read here.

Pharmexcil to organise seminar on 'Patent Litigation' in Mumbai on Aug 21

With cases of seizures of Indian drug shipments at several international ports increasing day by day, the Pharmaceutical Export Promotion Council (Pharmexcil) will organise a day-long seminar in Mumbai on August 21. The theme of the seminar will be 'Patent Litigation as Barrier in International Pharmaceutical Trade'.


The details can be read here.

Merck KGaA Has Requested Re-examination of the CHMP Opinion for Erbitux in Non-Small Cell Lung Cancer

Merck KGaA announced today that it has requested re-examination of the negative opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), for the use of Erbitux® (cetuximab) in combination with platinum-based chemotherapy for the first-line treatment of patients with non-small cell lung cancer (NSCLC).

The details can be read here.

FDA Approves New Drug Treatment for Type 2 Diabetes

July 31, 2009--The U.S. FDA today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The details can be read here.

Patents Issued Covering Stable Tablet Formulation and Once Daily Dosing Regimen for Kuvan

BioMarin Pharmaceutical Inc. announced today that the USPTO has issued patents covering stable tablet formulation and the approved once daily dosing regimen for Kuvan (sapropterin dihydrochloride) for the treatment of phenylketonuria (PKU).

The details can be read here.

Eli Lilly & Company and ScinoPharm Taiwan Ltd. Announce Settlement of Gemcitabine Litigation

Eli Lilly & Company and ScinoPharm Taiwan Ltd. announced today that they have reached an amicable resolution of all ongoing patent litigations between the companies relating to ScinoPharm's manufacture and sale of gemcitabine hydrochloride around the world.

The details can be read here.

PharmaForce Inc. Receives FDA Approval for First Generic of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP

PharmaForce, Inc., announced today that it has received approval from the U.S. FDA for its ANDA for Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, a generic version of Schering Corporation's Celestone Soluspan.

The details can be read here.

Roxane Laboratories, Inc. Announces the Launch of Risperidone Oral Solution 1mg/mL

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Risperidone Oral Solution, 1mg/mL by the U.S. Food and Drug Administration.

The details can be read here.