Thirty Million Women Will Gain From Health Reform Law, Including About 15 Million Uninsured

Approximately thirty million American women will gain from the new health reform law over the next ten years, according to a new report from The Commonwealth Fund, a private foundation based in New York…

Washington Week: Nonstop Action As FDA Closes Out July

WASHINGTON (MedPage Today) — It’s been an unusually hectic July for the FDA, and this past week was no exception. The agency approved a polypill to treat hypertension, and separate FDA advisory committees endorsed an investigational antiplatelet, grappled with safety issues involving a new spine device, and debated when it’s okay to change endpoints in [...]

FDA Panel Grapples With Changing Study Endpoint

ADELPHI, Md. (MedPage Today) — An FDA advisory panel was split this week over whether Pfizer should be allowed to substitute an endpoint in its clinical trial testing sildenafil as a treatment for kids with pulmonary arterial hypertension.

FDA Warns of Cure-All Product Based on Bleach

(MedPage Today) — The FDA has warned consumers not to use a product called Miracle Mineral Solution — which makes broad health claims — because it’s actually an industrial strength bleach.

FDA lifts hold, allows Geron to proceed with Phase I clinical trial of GRNOPC1 in spinal cord injury

Geron Corporation announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the clinical hold placed on Geron’s Investigational New Drug (IND) application has been lifted and the company’s Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed.

Biogen Idec And Swedish Orphan Biovitrum Present Data On Long-Lasting Hemophilia B Therapy At The World Federation Of Hemophilia Congress

Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (STO: SOBI) announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies’ long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients…

Eisai Announces U.S. Fda Approval For New Higher Dose Aricept® 23 Mg Tablet For The Treatment Of Moderate-To-Severe Alzheimer’s Disease

Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Aricept® (generic name: donepezil hydrochloride) 23 mg once daily tablet for the treatment of moderate-to-severe Alzheimer’s disease (AD)…

Bristol-Myers Squibb National Survey Finds A Disparity Between Health Care Providers And HIV Positive Patients

Bristol-Myers Squibb Company (NYSE: BMY) presented results from a national survey which found that emotional barriers, such as stigma, fear, denial and shame, and structural barriers, such as lack of knowledge, transportation, and insurance coverage, can prevent people living with HIV/AIDS (PLWHA) from seeking care and treatment…

GSK Receives CHMP Positive Opinion For A New Indication For Arixtra

GlaxoSmithKline (GSK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arixtra (fondaparinux),an anti-clotting drug (antithrombotic) for the treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis (SVT) of the lower limbs without concomitant deep-vein thrombosis…

Stop & Shop Supermarket announces voluntary recall of Nature’s Promise Alfalfa, Zesty Sprouts

The Stop & Shop Supermarket Company has announced a voluntary recall of Nature’s Promise Alfalfa and Zesty Sprouts because they have the potential to be contaminated with listeria monocytogenes.