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Antidepressant drug is effective in treating women with low libido

The drug flibanserin, which was originally created as an antidepressant, is effective in treating women with low libido, pooled results from three separate clinical trials have found.

17 Nov 2009

FDA approves NeurogesX's Qutenza patch for postherpetic neuralgia treatment

NeurogesX, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles.

17 Nov 2009

FDA approves Par Pharmaceutical's new painkiller drug

Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER.

17 Nov 2009

Statin therapy should still be used first to reach blood cholesterol levels before considering niacin

Heart experts at Johns Hopkins are calling premature the early halt of a study by researchers at Walter Reed Army Medical Center and Washington Hospital Center on the benefits of combining extended-release niacin, a B vitamin, with cholesterol-lowering statin medications to prevent blood vessel narrowing. Cardiovascular atherosclerosis, as it is also known, is believed responsible for one in three deaths in the United States each year.

17 Nov 2009

ARCA biopharma provides financial and Gencaro NDA update

ARCA biopharma, Inc. today announced its planned next steps in response to the May 29, 2009 Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for ARCA’s New Drug Application (NDA) seeking approval for GencaroTM (bucindolol hydrochloride) for the treatment of patients with chronic heart failure. Following receipt of the CRL, the Company and the FDA have held a series of meetings to discuss how best to address the requirements identified in the CRL.

17 Nov 2009

FDA approves CSL's seasonal and H1N1 flu vaccines for children

The U.S. Food and Drug Administration has approved the use of the CSL Limited's seasonal and 2009 H1N1 influenza vaccines to include children ages 6 months and older. These vaccine were previously approved for use in adults, ages 18 years and older

17 Nov 2009

Researchers attempt to slow the pace of infectious organisms' evolution to keep today's drugs effective

Infectious organisms that become resistant to antibiotics are a serious threat to human society. They are also a natural part of evolution. In a new project, researchers at the University of Gothenburg are attempting to find substances that can slow the pace of evolution, in order to ensure that the drugs of today remain effective into the future.

17 Nov 2009

Handwashing: A simple, effective way to prevent the spread of communicable diseases

In this day and age, with the latest in medical equipment and scientific advances adding both quantity and quality to our lives, it is easy to forget that the simplest actions can provide some of the most important results. In fact, your mother's instructions to "wash up before dinner" should be considered some of the soundest medical advice ever offered.

17 Nov 2009

Reorganizing the FDA could save Americans trillions of dollars over the next decade, says legal expert

While Congress and the rest of the nation turn the battle over healthcare reform into a pro-wrestling-style steel cage death match with enough rhetoric to choke an English professor, at least one expert is looking beyond the bills on the table for a different solution.

17 Nov 2009

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