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Cell Therapeutics' NDA for Pixantrone accepted by the FDA

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted and has filed for review the Company's New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). A Prescription Drug User Fee Act (PDUFA) date will be established by the FDA regarding the review of the pixantrone NDA by September 4th 2009.

24 Aug 2009

Biovail enters into an agreement with Santhera to develop and market JP-1730/fipamezole drug

Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into an agreement with Santhera Pharmaceuticals (Switzerland) Ltd., a subsidiary of Santhera Pharmaceuticals Holding AG (SIX: SANN) to acquire the U.S. and Canadian rights to develop and commercialize Santhera’s JP-1730/fipamezole for the treatment of Dyskinesia in Parkinson’s Disease (DPD). JP-1730/ fipamezole is a first-in-class compound that, in a recent Phase IIb study, displayed the potential to reduce levodopa-induced dyskinesia.

24 Aug 2009

Simcere Pharmaceutical Group's forty-two generic drugs included in China's Essential Drug List

Simcere Pharmaceutical Group ("Simcere" or the "Company"), 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 ("EDL"), which was issued by China's Ministry of Health ("MOH") on August 18, 2009.

24 Aug 2009

Pharmaceutical manufacturers increase lobbying

The Associated Press reports: "The pharmaceutical industry's primary trade group spent nearly $6.2 million lobbying in the second quarter on health care reform provisions, confirmation of two top federal officials and other issues, according to a recent disclosure report.

24 Aug 2009

Discovery of genetic biomarkers enable targeted personalised medication for Colorectal cancer

Colorectal cancer (CRC) is the second leading cause of cancer-related death in the Western world. Fortunately physicians today have an abundance of drug therapies available to improve survival length for more advanced cancer patients. Now the discovery of genetic biomarkers relevant to CRC means that targeted personalised medication is increasingly common.

24 Aug 2009

Lundbeck to launch Sabril in the US following FDA's NDA approval

Lundbeck Inc. (“Lundbeck”), 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.

24 Aug 2009

Biovail's patent infringement lawsuit against Cary Pharma may affect IntelGenx revenues

IntelGenx Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) ("IntelGenx") previously announced that the New Drug Application (NDA) filing for the antidepressant CPI-300, which it developed with Cary Pharmaceuticals ("Cary Pharma") had been accepted by the U.S. Food and Drug Administration (FDA) for standard review. CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin XL®.

24 Aug 2009

FDA issues complete response letter regarding the NDA for carisbamate

The U.S. 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.

23 Aug 2009

Adamas Pharmaceuticals forges agreement with U.S. Naval Health Research Center for evaluating triple combination antiviral drug

Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Naval Health Research Center for preclinical studies evaluating Adamas' triple combination antiviral drug (TCAD) therapy for influenza A, including novel influenza A/H1N1. TCAD therapy includes Adamas' investigational proprietary fixed-dose oral combination drug, to be administered adjunctively with a neuraminidase inhibitor, including Tamiflu (oseltamivir phosphate, Roche).

22 Aug 2009

Cortex Pharmaceuticals receives delisting notification from NYSE Amex

Cortex Pharmaceuticals, Inc. (NYSE Amex (COR)) reported that it has received a delisting notification from the NYSE Amex LLC indicating that it has not accepted the Company’s plan to regain compliance with the Exchange’s continued listing standards, as submitted by the Company in June.

21 Aug 2009

FDA approves Epocal's new glucose test on the epoc Blood Analysis System

Epocal, Inc., a leading edge provider of point of care technology, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market its new glucose test on the epoc Blood Analysis System.

21 Aug 2009

Nutra Pharma launches Cobroxin for chronic pain relief

Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has launched an over-the-counter (OTC) pain reliever, Cobroxin, for the treatment of Stage 2 (moderate to severe) chronic pain.

21 Aug 2009

Takeda Canada reacquires commercial rights for an oral type 2 diabetic treatment drug

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.

21 Aug 2009

Syntagon to deliver presentation on controlling genotoxic impurities

Leading contract research organisation, Syntagon, is to deliver a presentation on controlling genotoxic impurities at one of the Pharma industry’s highest profile events, CPhI Worldwide, being held this October in Madrid, Spain.

21 Aug 2009

Medicago and Ajanta Pharma forge MoU to commercialize seasonal influenza VLP-based vaccines in India

Medicago Inc., a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that it has signed a Memorandum of Understanding ("MOU") with Ajanta Pharma Limited ("Ajanta") to discuss and negotiate an agreement to commercialize Medicago's pandemic and seasonal influenza VLP-based vaccines in India and other territories.

21 Aug 2009

New antimalarial drug discovery project funded by European Commission

The European Commission is funding a two year, -500,000 project to co-ordinate European and international research into the development of new drugs to treat malaria.

21 Aug 2009

Newspapers examine debate over affordable drugs in developing countries

The Los Angeles Times examines how "activists in Washington, and Thailand and other developing countries are accusing the Obama administration of endangering access to affordable drugs to fight AIDS and other epidemic diseases."

21 Aug 2009

U.S District Court grants preliminary approval for the settlement of Sampson v. Robinson case

Bristol-Myers Squibb Company (NYSE:BMY) announced today that the United States District Court for the Southern District of New York has granted preliminary approval of settlement of Sampson v. Robinson, et al., Case No. 1:07-CV-06890 (on appeal: Case No. 08-5475), a shareholder action pursued derivatively on behalf of Bristol-Myers Squibb. The action concerned allegations relating to the efforts to settle the Plavix patent litigation in 2006. The proposed settlement is subject to final Court approval. The Court has set a final approval hearing for December 8, 2009 at 2 p.m. in the courtroom of the Honorable Paul A. Crotty, United States District Judge.

21 Aug 2009

Health Canada approves Anika Therapeutics' MONOVISC drug

Anika Therapeutics, Inc. (Nasdaq: ANIK), 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. Anika expects to launch MONOVISC this month through its long-term ORTHOVISC® distribution partner in Canada, Rivex Pharma Inc., the specialty drug distribution division of Aurora, Ontario-based Helix BioPharma Corp. (TSX: HBP). MONOVISC has been broadly available in the European Union since the second quarter of 2008.

21 Aug 2009

Influenza A H1N1 Real Time RT-PCR tests detect RNA of H1N1 influenza virus

Focus Diagnostics, the infectious disease diagnostics business of Quest Diagnostics Incorporated, today announced that its Influenza A H1N1 (2009) Real Time RT-PCR test is now available as a test kit for use by "high complexity" clinical laboratories in the U.S.

21 Aug 2009

Pharmaceutical News

Cell Therapeutics' NDA for Pixantrone accepted by the FDA

Biovail enters into an agreement with Santhera to develop and market JP-1730/fipamezole drug

Simcere Pharmaceutical Group's forty-two generic drugs included in China's Essential Drug List

Pharmaceutical manufacturers increase lobbying

Discovery of genetic biomarkers enable targeted personalised medication for Colorectal cancer

Lundbeck to launch Sabril in the US following FDA's NDA approval

Biovail's patent infringement lawsuit against Cary Pharma may affect IntelGenx revenues

FDA issues complete response letter regarding the NDA for carisbamate

Adamas Pharmaceuticals forges agreement with U.S. Naval Health Research Center for evaluating triple combination antiviral drug

Cortex Pharmaceuticals receives delisting notification from NYSE Amex

FDA approves Epocal's new glucose test on the epoc Blood Analysis System

Nutra Pharma launches Cobroxin for chronic pain relief

Takeda Canada reacquires commercial rights for an oral type 2 diabetic treatment drug

Syntagon to deliver presentation on controlling genotoxic impurities

Medicago and Ajanta Pharma forge MoU to commercialize seasonal influenza VLP-based vaccines in India

New antimalarial drug discovery project funded by European Commission

Newspapers examine debate over affordable drugs in developing countries

U.S District Court grants preliminary approval for the settlement of Sampson v. Robinson case

Health Canada approves Anika Therapeutics' MONOVISC drug

Influenza A H1N1 Real Time RT-PCR tests detect RNA of H1N1 influenza virus

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