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USFDA grants Sun Pharma subsidiary approval for generic Strattera capsules ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Strattera ®, atomoxetine hydrochloride capsules.

2 Sep 2010

FDA approves LUMIGAN eye drops for intraocular pressure reduction in open-angle glaucoma patients

Allergan, Inc. today announced the United States Food and Drug Administration (FDA) has approved LUMIGAN (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

2 Sep 2010

Event Pulse report reveals impact of new therapies on MS drug market

The study titled Event Pulse Preview: Multiple Sclerosis shows that 84% of neurologists expect to prescribe Gilenia for some MS patients if approved, but prescribing will likely be limited to second- or third-line therapy until concerns about safety and monitoring requirements are resolved.

1 Sep 2010

Report finds some donated malaria drugs are being stolen, resold In Africa

Some of the malaria drugs given to Africa by international donors are "being stolen and resold on commercial markets," according to a study to be released Thursday in the journal Research and Reports in Tropical Medicine, the Associated Press reports.

1 Sep 2010

Unpleasant short term side-effects of sunburn dont put off sun-seeking Brits

The research - commissioned by Superdrug and Cancer Research UK as part of their joint campaign to encourage people to enjoy the sun safely this summer - highlights the worrying lengths sun-seeking Brits are prepared to go to in search of a tan.

31 Aug 2010

pSivida announces FDA Priority Review status for Iluvien NDA

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has been notified that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien for the treatment diabetic macular edema (DME).

31 Aug 2010

Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that its lead clinical candidate STX-100 has been granted orphan drug status by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis, a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung.

31 Aug 2010

Halozyme identifies strategy to reintroduce HYLENEX

Halozyme Therapeutics, Inc. today announced the completion of its root cause investigation regarding HYLENEX manufacturing and has identified a corrective action plan and regulatory strategy to reintroduce HYLENEX to the market. Halozyme and Baxter are finalizing the materials for a meeting with the U.S. Food and Drug Administration to seek concurrence with the reintroduction strategy.

31 Aug 2010

Naurex announces GLYX-13 molecule recognized in “Top 10 to Watch" list for depression treatment

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders, today reported that its clinical stage candidate for the treatment of depression, GLYX-13, and its second-generation NRX-1050 series have been selected for inclusion on Windhover's list of the "Top 10 Most Interesting Neuroscience Projects to Watch."

31 Aug 2010

TearLab and AMO Canada enter cooperative marketing agreement

TearLab Corporation today announced that it has entered into a cooperative marketing agreement with Abbott Medical Optics Inc.'s subsidiary, AMO Canada Company. Under the agreement, AMO Canada's sales force will directly sell the TearLab™ Osmolarity System in Canada while TearLab will help promote AMO Canada's products for the relief of dry eye symptoms, including Blink® Moisturizing Eye Drops. Financial terms were not disclosed.

31 Aug 2010

Nutritional recommendations for management of sarcopenia published

Nutritional recommendations for the management of sarcopenia -- also described as age-related muscle and functional loss -- were published this past week in the clinical publication, Journal of American Medical Directors Association.

31 Aug 2010

EDIMS licenses First DataBank's National Drug Data File Plus database

First DataBank, a leading provider of drug databases that help drive patient safety, and EDIMS, a leading provider of interoperable emergency department (ED) information management systems, today announced they have licensed First DataBank's National Drug Data File (NDDF) Plus™ database to offer hospitals greater choice in trusted third-party drug database information to use and integrate with EDIMS ED electronic health record (EHR).

31 Aug 2010

Bionovo receives positive guidance for Menerba drug candidate

Bionovo, Inc. announced today that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba.

31 Aug 2010

SCOLR Pharma signs sales support agreement with Emerson Group

SCOLR Pharma, Inc. today announced that it has signed an agreement with The Emerson Group to provide sales support for the Company's new line of extended-release nutritional and over-the-counter drug products.

31 Aug 2010

Ralphs Grocery Company to offer seasonal flu vaccine at $25

Ralphs Grocery Company is making it easy and affordable for customers to stay healthy by getting seasonal flu immunizations early.

31 Aug 2010

Using clopidogrel, PPIs increases cardiac damage risk: Study

Patients with coronary artery disease undergoing stent implantation are often prescribed the antiplatelet drug, clopidogrel. This drug prevents blood clots, but is known to have a side-effect that can cause stomach bleeding. Consequently, many users are also prescribed a proton pump inhibitor (PPI). Now, however, a meta-analysis of almost 160,000 patients carried out at the Medical University of Vienna and Wilhelminenhospital, Vienna, has shown that simultaneous use of these drugs can increase the risk of cardiac damage.

31 Aug 2010

BARDA awards $27 million contract to Achaogen for antibiotic development

The U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) today awarded a contract to develop an antibiotic that could be used against possibly two types of bioterrorism as well as common infections that are becoming resistant to antibiotics.

31 Aug 2010

Over use of decongestants by women leads to preterm birth delivery: Study

A new study led by Boston University School of Public Health (BUSPH) epidemiologists has found that women who took over-the-counter decongestants during their pregnancies are less likely to give birth prematurely.

31 Aug 2010

Salix Pharmaceuticals to settle patent litigation of Novel's generic version of MOVIPREP

Salix Pharmaceuticals, Ltd. today announced that Salix and Norgine B. V. have entered into an agreement with Novel Laboratories, Inc. to settle patent litigation currently pending in the U.S. District Court for the District of New Jersey (Civil Action No. 3:08-02311 (FLW)(TJB)) regarding Novel's proposed generic version of MOVIPREP.

31 Aug 2010

Roche's MabThera continues to dwarf recently launched monoclonal antibodies: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia, 41 percent of surveyed European hematologist-oncologists say that the favorable efficacy profile of Roche's MabThera (rituximab) is the most significant driver of their use of this brand, while 26 percent say MabThera's favorable risk-benefit profile is the most significant driver.

31 Aug 2010