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Vital Therapies expands SILVER clinical trial to Middle East

Vital Therapies, Inc., is pleased to announce that the first subject has been enrolled at National Guard Hospital in Riyadh, Kingdom of Saudi Arabia in the further expansion of its SILVER clinical trial to the Middle East. The trial is evaluating whether VTI's biological cellular therapy product, ELAD, can prevent deterioration of liver function and improve the survival of patients with acute-on-chronic liver failure.

17 Sep 2010

Arena, Eisai provide update on lorcaserin NDA

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 9 to 5 that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks, when used long-term in a population of overweight and obese individuals to allow marketing approval.

17 Sep 2010

Elite Pharmaceuticals signs agreements with Precision Dose for four generic products

Elite Pharmaceuticals, Inc. announced today the signing of a license agreement and a manufacturing and supply agreement with Precision Dose, Inc. which has a wholly owned subsidiary, TAGI Pharma, Inc. which will distribute the products covered by the agreement. Pursuant to the License Agreement, TAGI Pharma will market and sell four Elite generic products in the United States, Puerto Rico and Canada.

17 Sep 2010

NIH to implement ScriptPro pharmacy automation systems

ScriptPro has been awarded a contract to provide pharmacy automation systems to the National Institutes of Health (NIH) in Bethesda, MD.

17 Sep 2010

Metabolic Solutions to present MSDC-0160 clinical candidate data at EASD conference

Metabolic Solutions Development Company (MSDC), will present research at the European Association for the Study of Diabetes (EASD) annual conference in Stockholm, Sweden on Sept. 23, 2010. The research indicates that the company's clinical candidate, MSDC-0160, promotes the proliferation of stem cells that create brown fat, leading to the creation of more brown fat. The research was conducted in tissue cultures and mice.

17 Sep 2010

Common Alzheimer's disease drug enhances learning of new skills

Research on a drug commonly prescribed to Alzheimer's disease patients is helping neuroscientists at the University of California, Berkeley, better understand perceptual learning in healthy adults.

17 Sep 2010

Researchers reveal Prozac reactions to increase serotonin level

The response time to antidepressants, such as Prozac, is around three weeks. The adaptation mechanisms of the neurons to antidepressants has, until now, remained enigmatic. In particular, the researchers have revealed, for the first time, a sequence of reactions caused by Prozac at the neuron level, which contributes to an increase in the amounts of serotonin, a chemical "messenger" essential to the brain, and deficient in depressive individuals.

17 Sep 2010

Diclectin's effectiveness for morning sickness: Report

In the latest issue of the American Journal of Obstetrics and Gynecology, a group of American and Canadian researchers report on the effectiveness of Diclectin(R) (the delayed-release formulation of doxylamine and vitamin B6) for morning sickness.

17 Sep 2010

Alcohol addiction drug may help opioid addicts: FDA panel considers reports

A U.S. Food and Drugs Administration (FDA) panel, this Thursday agreed that a new drug Vivitrol helps alcoholics and opioid addicts kick the habit. The panel voted 11 to 2 that there was sufficient evidence from a single clinical trial that Vivitrol is effective when it comes to helping people addicted to painkillers.

17 Sep 2010

FDA Advisory Committee recommends approval of Alkermes' VIVITROL for opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.

17 Sep 2010

FDA approves CRT-D device to treat heart failure patients

The U.S. Food and Drug Administration today approved a new indication for three cardiac resynchronization therapy defibrillators (CRT-D) used to treat certain heart failure patients.

17 Sep 2010

FDA approves Akorn's Erythromycin Ophthalmic Ointment USP 1 g

Akorn, Inc. a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Erythromycin Ophthalmic Ointment USP 1 g as a supplement to the Company's already approved Abbreviated New Drug Application (ANDA) for Erythromycin Ophthalmic Ointment USP 3.5 g. The company has begun shipping the product to its customers.

17 Sep 2010

NovaBay Pharmaceuticals delivers poster presentations on Aganocide compound at ICAAC Conference

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic resistant infections, delivered four poster presentations on its Aganocide compounds at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston, MA.

16 Sep 2010

Forest Pharmaceuticals to pay $300 million as penalty for criminal actions

The U.S. Food and Drug Administration (FDA), working in close coordination with the U.S. Department of Justice (USDOJ), today announced that Forest Pharmaceuticals, Inc. entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection.

16 Sep 2010

Generics drugs in Medicare program saved $33 billion in 2007: CBO

New research released today by the Congressional Budget Office (CBO) found that the use of generic medications rather than brand-name medications in Medicare Part D saved beneficiaries and the program about $33 billion in 2007, while an additional $14 billion in savings is expected as first-time generics enter the market through 2012.

16 Sep 2010

Anonymous Funding promotes drug development for Fragile X syndrome treatment

Funding from an anonymous wealthy family has been the secret to progress, at long last, in developing drugs that show promise for helping millions of people worldwide with Fragile X syndrome, the most common genetic cause of autism. That's the topic of a fascinating article in the current issue of Chemical & Engineering News (C&EN), ACS' weekly newsmagazine.

16 Sep 2010

Researchers develop infected tissue model for Aganocide compounds

Two common and important human pathogens, P. aeruginosa and S. aureus, are implicated in many clinical diseases of the eye and skin, including keratitis and impetigo, respectively. Infections with their associated toxins can result in the destruction of underlying tissue.

16 Sep 2010

Abbott issues statement in response to FDA's mixed vote for weight loss medication sibutramine

The U.S. Food and Drug Administration today held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of SCOUT and the weight loss medication sibutramine (sold as Meridia® in the United States).

16 Sep 2010

bluebird bio publishes LentiGlobin gene therapy clinical trial data results

bluebird bio an emerging leader in the development of innovative gene therapies for severe genetic disorders, today announced publication in the journal Nature of its promising Phase 1/2 data highlighting positive results of LentiGlobin gene therapy treatment in a young adult with severe beta-thalassemia, a blood disorder that is one of the most frequent inherited diseases.

16 Sep 2010

Orexo signs agreement with NewBridge for Abstral drug sale

Orexo AB announces today that an exclusive licensing and distribution agreement has been signed with NewBridge Pharmaceuticals for Abstral, Orexo´s product for the treatment of breakthrough cancer pain.

16 Sep 2010