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Additional vaccine for 2009 H1N1 flu approved by FDA

The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

16 Nov 2009

ECR Pharmaceuticals to commercialize and manufacture ZolpiMist in the U.S. and Canada

NovaDel Pharma Inc. today announced its entry into an exclusive license and distribution agreement with ECR Pharmaceuticals Company, Inc., a wholly owned subsidiary of Hi-Tech Pharmacal Co., Inc. to commercialize and manufacture ZolpiMist™ in the United States and Canada. ZolpiMist™ is our oral spray formulation of zolpidem tartrate approved by the FDA in December of 2008.

16 Nov 2009

Eisai's LUSEDRA Injection now available for MAC sedation

Eisai Inc. today announced that LUSEDRA(TM) (fospropofol disodium) Injection is now available for use by persons trained in the administration of general anesthesia. LUSEDRA, an aqueous solution, is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

16 Nov 2009

Decision Resources: Neuropathic pain drug market to be $9.7B in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the neuropathic pain drug market -- driven by the launches of several novel therapies -- will increase from $6 billion in 2008 to $9.7 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

16 Nov 2009

4SC raises funds for further development of its current product pipeline

4SC AG, a drug discovery and development company, today announced the successful completion of a capital increase, after the Management Board, with the approval of the Supervisory Board, passed a resolution to authorise an increase of share capital on 23 October, 2009.

16 Nov 2009

Drug makers hike prices, lobby hard as reform efforts progress

Drug makers are bracing for reform by raising their prices - by 9 percent in the last year, perhaps the fastest rate since 1992, The New York Times reports. This happened "even as drug makers promise to support Washington's health care overhaul by shaving $8 billion a year off the nation's drug costs after the legislation takes effect." The increases "will add more than $10 billion to the nation's drug bill, which is on track to exceed $300 billion this year."

16 Nov 2009

Onyx Pharmaceuticals acquires Proteolix

Onyx Pharmaceuticals, Inc. today announced that the company has completed its acquisition of Proteolix, Inc., a privately held biopharmaceutical company focused on discovering and developing novel therapies that target the proteasome for the treatment of hematological malignancies and solid tumors.

16 Nov 2009

Gentium to present Defibrotide trial data at the ASH meeting

Gentium S.p.A. announced today that results from the Company’s Phase II/III Pediatric Prevention trial and Phase III Treatment trial for Defibrotide of Hepatic Veno-Occlusive Disease will be presented at American Society of Hematology Conference (ASH), December 5-8 in New Orleans.

16 Nov 2009

Erbitux recognized as one of the major clinical cancer advances of 2009

The American Society of Clinical Oncology (ASCO) has once again recognized Erbitux® (cetuximab) as one of the major clinical cancer advances of 2009. This year Erbitux was selected by ASCO for providing the first significant increase in survival for 30 years in the treatment of patients with 1st-line recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

16 Nov 2009

FDA approves Lysteda for treating menorrhagia

Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S. Food and Drug Administration (FDA) approval for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia.

16 Nov 2009

Windhover Information selects Oncothyreon's PX-866 among top 10 oncology projects for partnering

Oncothyreon Inc. today announced that the Company's product candidate PX-866, a PI-3 kinase inhibitor, has been selected by Windhover Information, Inc., as one of the Top 10 most promising oncology projects in development that is available for partnering.

16 Nov 2009

Sinobiopharma's 23 generic drugs on China's National Essential Drugs List

Sinobiopharma, Inc. is pleased to announce that 23 generic drugs for which the Company has production rights are listed in China's National Essential Drugs List, which covers pharmaceuticals used to treat up to 80 percent of the most common diseases in China.

16 Nov 2009

FDA issues a Complete Response Letter for Human Genome Sciences' raxibacumab BLA

Human Genome Sciences, Inc. today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company’s Biologics License Application (BLA) requesting the approval of raxibacumab for use in the treatment of inhalational anthrax. The FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA.

16 Nov 2009

Genta announces Phase 3 trial results of Genasense

Genta Incorporated today announced preliminary results from AGENDA, the Company’s Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. AGENDA is a randomized, double-blind, placebo-controlled trial of dacarbazine (DTIC) administered with or without Genasense® in patients who have not previously received chemotherapy.

16 Nov 2009

Macomb County targets pregnant women and health care workers for its next two H1N1 vaccine clinics

Pregnant women, their families and health care workers are being targeted by the Macomb County Health Department for its next two H1N1 vaccine clinics, department officials announced today. All are being offered at no charge.

16 Nov 2009

Inovio Biomedical reports financial results for the three and nine months ended September 30, 2009

Inovio Biomedical Corporation today reported financial results for the three and nine months ended September 30, 2009.

16 Nov 2009

Foreign particles in some products filled at Genzyme's Allston Landing facility, "Dear Doctor" letter issued

BioMarin Pharmaceutical Inc. announced today that Genzyme notified the company that, in rare circumstances, it has detected foreign particles in some products filled at the Allston Landing facility. To ensure that patients are not exposed to foreign particles during product administration, Genzyme has issued a "Dear Doctor" letter to all physicians treating patients with enzyme replacement products that it markets, including Aldurazyme.

16 Nov 2009

Ketamine use increasing faster than any other drug in the UK, shows research

The first ever large-scale, longitudinal study of ketamine users has been published online today in the journal Addiction. With Ketamine (K, Special K) use increasing faster than any other drug in the UK (British Crime Survey, 2008) this research showing the consequences of repeated ketamine use provides valuable information for users and addiction professionals alike.

16 Nov 2009

Effect of niacin or ezetimibe added to chronic statin therapy on carotid intima media thickness: Study

In combination with statins, adding a medication that raises high-density lipoprotein (HDL) cholesterol was more effective in reversing artery wall plaque buildup and in reducing heart disease risk than adding a drug that lowers low-density lipoprotein (LDL) cholesterol, researchers reported today at the American Heart Association Scientific Sessions 2009.

16 Nov 2009

Proteo's Elafin recommended for orphan drug status in Europe

The Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA) has issued a recommendation granting orphan drug status to Proteo's drug candidate Elafin for the treatment of esophagus carcinoma. The orphan drug status will become effective upon ratification of this recommendation by the European Commission.

16 Nov 2009