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Bioniche Life Sciences update on Phase III clinical program for evaluating Urocidin

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on its Phase III clinical program evaluating Urocidin(TM) in the treatment of bladder cancer.

24 Aug 2009

WHO appeals for donated, low-cost H1N1 vaccines

The WHO's flu chief Keiji Fukuda on Saturday called upon wealthy nations and vaccine manufacturers to donate H1N1 (swine) flu vaccines to developing countries, the Associated Press reports.

24 Aug 2009

Orphan drug status granted to BioCancell's BC-819 drug

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.

24 Aug 2009

P&G's global pharmaceuticals business sold to Warner Chilcott for $3.1 billion

The Procter & Gamble Company and Warner Chilcott plc today 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.

24 Aug 2009

Santaris Pharma to discover and develop new RNA-based medicines for treating rare genetic disorders

Santaris Pharma A/S, a privately-held biopharmaceutical company focused on developing RNA-based drugs targeted to disease-related mRNAs and microRNAs, today announced a multi-year worldwide strategic alliance with Shire plc to discover and develop new RNA-based medicines to treat rare genetic disorders.

24 Aug 2009

Osteologix announces receipt of Decision to Grant a Patent from JPO for NB S101 osteoporosis drug candidate

Osteologix, Inc. (OTCBB:OLGX) 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 patent claims cover the treatment of osteoporosis and related bone conditions using NB S101 (strontium malonate), the Company's lead osteoporosis drug candidate.

24 Aug 2009

Simcere to collaborate with Sun Yat-Sen University Cancer Center to research and develop anti-cancer drugs

Located in Guangzhou, Sun Yat-Sen University Cancer Center is one of China's renowned cancer research institutions, prominent in pre-clinical and clinical oncology research. The Sun Yat-Sen University Cancer Center was established to research anti-cancer treatments with a specific focus on developing major innovative drugs.

24 Aug 2009

Phase 2 clinical study of Resolvin RX-10045 for dry eye syndrome provides positive data

Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, today announced positive data from a Phase 2 clinical study evaluating RX-10045, a resolvin administered as a topical eye drop for the treatment of patients with chronic dry eye syndrome.

24 Aug 2009

PLoS Medicine's editors to eventually stamp ghostwriting

Today, PLoS Medicine places in the public domain all documents - around 1500 - released after the journal and The New York Times intervention in the Prempro case. The documents, are available on the PLoS Medicine website, and are uploaded in the form that PLoS received them from the court.

24 Aug 2009

NovaBay Pharmaceuticals to deliver two poster presentations describing results from new studies of NVC-422

NovaBay(R) Pharmaceuticals, Inc., a clinical stage company developing non-antibiotic anti-infective compounds for the treatment or prevention of a wide range of bacterial, viral, and fungal infections, will deliver two poster presentations at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, CA.

24 Aug 2009

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

Pharmaceutical News

Bioniche Life Sciences update on Phase III clinical program for evaluating Urocidin

WHO appeals for donated, low-cost H1N1 vaccines

Orphan drug status granted to BioCancell's BC-819 drug

P&G's global pharmaceuticals business sold to Warner Chilcott for $3.1 billion

Santaris Pharma to discover and develop new RNA-based medicines for treating rare genetic disorders

Osteologix announces receipt of Decision to Grant a Patent from JPO for NB S101 osteoporosis drug candidate

Simcere to collaborate with Sun Yat-Sen University Cancer Center to research and develop anti-cancer drugs

Phase 2 clinical study of Resolvin RX-10045 for dry eye syndrome provides positive data

PLoS Medicine's editors to eventually stamp ghostwriting

NovaBay Pharmaceuticals to deliver two poster presentations describing results from new studies of NVC-422

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

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

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