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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

European Commission approves SmPC update for VIRAMUNE in HIV treatment

Boehringer Ingelheim announced today that the European Commission has approved an update to the Summary of Product Characteristics (SmPC) for VIRAMUNE (nevirapine) in the treatment of patients with HIV.

16 Sep 2010

GSK, Genmab to refocus on ofatumumab development program in autoimmune indications

GlaxoSmithKline and Genmab A/S Following the 1st July announcement by GSK and Genmab of an amendment to the collaborative agreement for ofatumumab in which GSK assumed development responsibility for autoimmune indications, GSK and Genmab announced today plans to refocus the development program of ofatumumab in autoimmune indications.

16 Sep 2010

Tetraphase Pharmaceuticals presents preclinical data of TP-434 antibacterial drug

Tetraphase Pharmaceuticals, Inc., today presented encouraging preclinical data for its lead drug candidate, TP-434, which showed the potent antibacterial activity of TP-434 against a very broad spectrum of susceptible and multidrug-resistant pathogens.

16 Sep 2010

Researchers find NCT analogs show antimicrobial, anticoagulant activity

Catheter-related bacteremia can be a significant cause of sickness and death for hemodialysis patients. The anticoagulant heparin is commonly used as a catheter lock solution to prevent thrombosis; however has limited antimicrobial activity.

16 Sep 2010

ASG-5ME compound kills pancreatic cancer cells: Researchers

A new investigational drug designed to penetrate and attack pancreatic cancer cells has been administered to a patient for the first time ever at the Virginia G. Piper Cancer Center at Scottsdale Healthcare.

16 Sep 2010

JAK oral medication produces lasting relief for patients with myelofibrosis: Researchers

An oral medication produces significant and lasting relief for patients with myelofibrosis, a debilitating and lethal bone marrow disorder, researchers at The University of Texas MD Anderson Cancer Center report in the Sept. 16 New England Journal of Medicine.

16 Sep 2010

K.U.Leuven enters license agreement with Pfizer to commercialize anti-HIV drugs

K.U.Leuven announced today that on July 29th, 2010 they entered into a license agreement with Pfizer. The license agreement grants Pfizer exclusive and sublicenseable worldwide rights to further develop and commercialise K.U.Leuven's compounds with a new mechanism of action for the potential treatment of individuals infected with HIV, the virus that causes AIDS.

16 Sep 2010

FDA updates dosing recommendation for Valcyte medication

The U.S. Food and Drug Administration is notifying health care professionals of updated dosing recommendations for Valcyte (valganciclovir) oral tablets and solution used by children and adolescents receiving a kidney or heart transplant.

16 Sep 2010

Researchers investigate antimicrobial activity of Aganocide compounds against H1N1

Fears over the influenza A virus (H1N1; sometimes referred to as swine flu) have motivated researchers to investigate the antimicrobial activity of the Aganocide compounds against viruses. In a study presented at this year's Interscience Conference on Antimicrobial Agents and Chemotherapy, a team led by Professor Markus Nagl, MD of Medical University of Innsbruck and including D. Debabov, PhD and K. Hybiske, PhD of NovaBay Pharmaceuticals evaluated the in vitro virucidal activity of three compounds: N-chlorotaurine, a compound produced by human phagocytes; and two NCT analogs, NVC-612 and NVC-422.

16 Sep 2010

Access Pharmaceuticals launches product website for MuGard

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company specializing in products for cancer and supportive care, announced today it has launched www.MuGard.com. The patient- and healthcare professional- focused site is a comprehensive resource offering educational material on oral mucositis, patient analysis, MuGard product and how-to-order information.

15 Sep 2010

Bruner to encourage FDA advisory committee to consider effectiveness of obesity drug Lorcaserin

On September 16, Denise Bruner, MD, FASBP will speak in favor of FDA approval for the new obesity drug Lorcaserin, during the open public hearing hour at the Endocrinologic and Metabolic Drug Advisory Committee meeting.

15 Sep 2010