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FDA ADAC recommends approval of Quad for HIV-1 infection

Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.

14 May 2012

NBHA commends FDA for continuing investigation of bisphosphonate treatment for osteoporosis

In response to today's Perspective pieces published in the New England Journal Of Medicine, the National Bone Health Alliance (NBHA), a public-private partnership bringing together the expertise and resources of its 42 members from the private and non-profit sectors to collectively advance bone health and prevent disease, commends the U.S. Food and Drug Administration (FDA) for continuing to investigate the risks and benefits of long-term bisphosphonate treatment.

11 May 2012

Anti-epilepsy drug phenobarbital stunts neuronal growth

A brain study in infant rats demonstrates that the anti-epilepsy drug phenobarbital stunts neuronal growth, which could prompt new questions about using the first-line drug to treat epilepsy in human newborns.

11 May 2012

FDA panel recommends approval of Truvada as preventive treatment for HIV

"In a move that could lead to a new milestone for treatment in the evolution of the worldwide AIDS epidemic," a Food and Drug Administration (FDA) panel on Thursday recommended Gilead Sciences' Truvada as a treatment for preventing HIV infection among healthy people at risk of contracting the virus, Reuters reports, noting, "It already has FDA approval to treat people infected with the human immunodeficiency virus".

11 May 2012

FDA advisory committee supports lorcaserin for weight management

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.

11 May 2012

BioTrends tracks uptake of Yervoy and Zelboraf for advanced melanoma

BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, has released findings from the second wave of its LaunchTrends® Yervoy and Zelboraf report, in which 103 U.S.-based medical oncologists were surveyed about their current and expected treatment patterns in advanced melanoma.

11 May 2012

Mylan introduces Atorvastatin Calcium in France, Belgium, UK, Ireland and the Netherlands

Mylan Inc. today announced that it has launched Atorvastatin Calcium Tablets, 10 mg, 20 mg, 40 mg and 80 mg in France, Belgium, the UK, the Netherlands and Ireland.

11 May 2012

CTI receives EU conditional marketing authorization for Pixuvri to treat non-Hodgkin B-cell lymphomas

CellTherapeutics today announced that it has received conditional marketing authorization from the European Commission for Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. Pixuvri is the first approved treatment in the European Union in this patient setting.

11 May 2012

HIV prevention drug receives FDA panel's backing

The drug has already been approved as a treatment for HIV/AIDS. The FDA is expected to decide about approval by June 15.

11 May 2012

Drug manufacturers draw attention for politics and pain killers

Politico examines the relationship between industry-group PhRMA and congressional Republicans in the post-health-reform-debate landscape.

11 May 2012

MSF says additional resources needed to improve ART access in Burma

Medecins Sans Frontieres (MSF), the largest provider of antiretroviral treatment (ART) in Burma, also known as Myanmar, are calling for the gap between the need for and access to ART in the country to be closed, the Guardian reports.

11 May 2012

CAPE arrests growth of prostate cancer tumors

Could it be that a remedy from thousands of years ago holds the secret to stopping prostate cancer? A newly published study furthers the exploration of caffeic acid phenethyl ester (CAPE) and its potential anticarcinogen and antioxidant properties. The demonstrated ability of CAPE to stop prostate cancer tumors from growing may soon have it earning a spot among other natural remedies for prostate cancer treatment.

11 May 2012

Administering vitamin K2 could possibly help patients with Parkinson's

Neuroscientist Patrik Verstreken, associated with VIB and KU Leuven, succeeded in undoing the effect of one of the genetic defects that leads to Parkinson's using vitamin K2. His discovery gives hope to Parkinson's patients.

11 May 2012

Government investigators pinpoint $5.6 billion in 'suspect' Medicare billings from pharmacies

This report from the Health and Human Services inspector general concluded that corner drugstores are vulnerable to fraud.

11 May 2012

$EC approves CTI’s Pixuvri to treat multiply relapsed or refractory aggressive NHL$

EC approves CTI’s Pixuvri to treat multiply relapsed or refractory aggressive NHL

Cell Therapeutics, Inc. today announced that it has received conditional marketing authorization from the European Commission for Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas.

11 May 2012

TherapeuticsMD introduces third prescription prenatal vitamin

TherapeuticsMD, Inc., parent company of vitaMedMD, LLC, a specialty pharmaceutical company, announced that on May 10, 2012 it launched its third prescription prenatal vitamin, vitaMedMD RediChew Rx, following the successful launch of vitaMedMD One Rx earlier this month and vitaMedMD Plus Rx last month.

11 May 2012

Eisai, Arena announce expansion of lorcaserin marketing and supply agreement

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today the expansion of the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. Lorcaserin is an investigational drug candidate intended for weight management.

11 May 2012

Cardionovum to introduce two DEB dilatation catheter product families

Cardionovum GmbH will launch two drug-eluting balloon (DEB) dilatation catheter product families at next week's EuroPCR 2012 congress: Paclitaxel-coated drug-eluting balloons for coronary and peripheral applications.

11 May 2012

FDA ADAC recommends approval of Gilead’s Truvada for HIV

Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada(emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP.

11 May 2012

Georgia Tech project to design new warehousing and storage system for vaccines, drugs

The Georgia Institute of Technology has received a $100,000 Grand Challenges Explorations grant from the Bill & Melinda Gates Foundation. The program funds individuals worldwide to explore ideas that can break the mold in how persistent global health and development challenges are solved.

10 May 2012