Pharmaceutical News

RSS

Prescription drug abuse reaches epidemic proportions

Poisoning is now the second leading cause of unintentional injury death in the U.S. While several recent high-profile Hollywood celebrity cases have brought the problem to public attention, the rates of unintentional poisoning deaths have been on the rise for more than 15 years.

6 Apr 2010

Dalfampridine drug for multiple sclerosis now available in the U.S.

A drug whose clinical benefit in treating multiple sclerosis was discovered at Rush University Medical Center was approved by the Food and Drug Administration on January 22 and is now available in the U.S.

6 Apr 2010

New formulation of controlled-release drug OxyContin approved

The U.S. Food and Drug Administration today approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication.

6 Apr 2010

Chinese SFDA approves Erye Pharmaceutical to manufacture generic Cloxapen

NeoStem, Inc., an international biopharmaceutical company with operations in the U.S. and China, announced that its Suzhou Erye Pharmaceutical subsidiary ("Erye") recently received approval from the State Food and Drug Administration (SFDA) in China to manufacture the sterile active pharmaceutical ingredient (API) of the anti-infective cloxacillin sodium.

5 Apr 2010

Perrigo, Cobrek Pharmaceuticals receive FDA approval for generic Evoclin Foam 1%

Perrigo Company today announced that together with its partner Cobrek Pharmaceuticals, Inc. final approval has been received from the U.S. Food and Drug Administration to manufacture and market Clindamycin Phosphate Foam 1%, a generic version of Evoclin® Foam 1% of Stiefel. As the ANDA was first to file with a Paragraph IV certification against Evoclin®, 180 days of generic exclusivity was granted by the U.S. Food and Drug Administration.

5 Apr 2010

Yongkangmen Health and Drug Chain Store to market and sell China Kangtai Cactus Biotech's products

China Kangtai Cactus Biotech Inc., a vertically integrated grower, developer, manufacturer and marketer of a variety of cactus-based products in China, announced today that it has signed a three-year marketing and sales agreement with Yongkangmen Health and Drug Chain Store Group Ltd. to sell its nutritious and patented cactus-based products, including nutraceuticals, health food, and health and energy drinks.

5 Apr 2010

Side effects may limit use of Prometheus's Lotronex for IBS

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that thought leaders believe Prometheus's Lotronex has efficacy advantages over current and emerging therapies for non-constipation predominant irritable bowel syndrome but side effects associated with the drug limit its use.

5 Apr 2010

FDA grants Keryx Biopharmaceuticals Fast Track designation for perifosine

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that its partner, Keryx Biopharmaceuticals, was granted Fast Track designation by the U.S. Food and Drug Administration for perifosine (KRX-0401), 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 refractory advanced colorectal cancer.

5 Apr 2010

Halozyme Therapeutics secures multiple commercial supply agreements for rHuPH20

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced the execution of multiple commercial supply agreements with its existing manufacturing partners. Halozyme amended an existing commercial supply agreement with Avid Bioservices, Inc., entered into a new commercial supply agreement with Avid and entered into a new commercial supply agreement with Cook Pharmica LLC.

5 Apr 2010

Request for lift of full clinical hold on Proellex program

Repros Therapeutics Inc. today announced that the Company has requested a lift of the full clinical hold on its oral drug Proellex® being developed for the treatment of uterine fibroids and endometriosis. On August 4, 2009, the FDA noted that further testing of Proellex® was placed on full clinical hold due to findings of serious adverse events associated with liver toxicity.

5 Apr 2010

Warner Chilcott, sanofi-aventis amend Actonel global collaboration agreement

Warner Chilcott plc and sanofi-aventis announced today an amendment to the Actonel® global collaboration agreement with respect to the parties' arrangement in the United States and Puerto Rico. Under the terms of the amendment, Warner Chilcott will take full operational control over the promotion, marketing and R&D decisions for Actonel in the United States and Puerto Rico, and will assume responsibility for all associated costs relating to those activities.

5 Apr 2010

Spectrum Pharmaceuticals reports $15.7M revenue from ZEVALIN sales in 2009

Spectrum Pharmaceuticals, Inc., a commercial-stage biotechnology company with a primary focus in oncology, today reported financial results for the fourth quarter and fiscal year ended December 31, 2009.

5 Apr 2010

2009 Harris Interactive RQ Study finds decline in reputation of Pharmaceuticals

After hitting rock bottom during the height of greed, bailouts, and the economic crisis in 2008, the American public's perceptions of the reputation of corporate America seem to be bouncing back. This, according to the findings of the 2009 Harris Interactive RQ Study, which measures the reputations of the 60 Most Visible Companies in the U.S.

5 Apr 2010

China's SFDA finds certain batches of Jiangsu Yanshen's human use rabies vaccine substandard

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today reported that China's State Food and Drug Administration ("SFDA") issued a statement on its investigation into the human use rabies vaccine manufactured by Jiangsu Yanshen Biological Technology Stock Co., Ltd.. Simcere obtained a controlling stake in Jiangsu Yanshen on October 24, 2009.

5 Apr 2010

Rebirth of the cursed drug Thalidomide

Thalidomide was once a dreaded name in the Pharmaceutical industry. It was initially marketed in some European countries nearly 5 decades back as a sedative and after millions of pregnant women took it for morning sickness it had devastating results on the babies. The babies were born with flippers instead of limbs a condition known as phocomelia. Since then it has been under strict control.

5 Apr 2010

Are Australians popping too many pills?

These reports have emerged from a Daily Telegraph investigation. Australian Medical Association vice president, GP and former Pharmaceutical Benefits Advisory Committee member Dr Steve Hambleton said the resons for these trends may include the increasing population of the aged, newer medicines as well as a rise in chronic lifestyle ailments like diabetes and high blood pressure.

5 Apr 2010

Flu vaccine shortage in New Zealand

The overwhelming demand for the flu vaccine has been seen as the biggest cause for its shortage in New Zealand. Despite 530,000 doses of the vaccine being distributed last month, there are some medical practices where the supply is woefully inadequate to meet the demand. This has resulted in the Ministry of Health bringing in shipments of 95,000 more doses.

5 Apr 2010

New report assesses optimal future for REMS

Two years after the Food and Drug Administration Amendments Act of 2007 gave FDA new powers to require Risk Evaluation and Mitigation Strategies for higher risk drugs and biologics, a new report concludes that an optimal future for REMS is possible if the agency adopts a systems approach when designing REMS programs and takes advantage of new technologies -- from electronic medical records to genetic testing -- that are changing the way medicine is practiced.

5 Apr 2010

NHS cancer patients to receive latest and best treatments available

Cancer patients on the National Health Service may soon be offered expensive life extending drugs which are currently denied to them. David Cameron has proposed on behalf of the Conservatives that the drugs that are licensed and prescribed by the health consultant of the patient should be made available to the cancer patient, irrespective of the NHS rationing.

5 Apr 2010

Fireside chat: BioSante's LibiGel and GVAX cancer vaccines portfolio

BioSante Pharmaceuticals, Inc. today announced that a BioSante presentation and corporate discussion are available at http://www.rodm.tv/video1269553400.

3 Apr 2010