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Doctors still prescribe higher-dose menopausal hormone therapy pills

Doctors across the country are still prescribing higher-dose menopausal hormone therapy pills, despite clinical evidence that low doses and skin patches work just as well and carry fewer health risks. That's what researchers at the Stanford University School of Medicine found in a study that will be published online Dec. 2 in Menopause: The Journal of the North American Menopause Society.

3 Dec 2010

Teva comments on Lovenox’s patent infringement lawsuit

Teva Pharmaceutical Industries Ltd. commented today on the patent infringement lawsuit filed by Momenta Pharmaceuticals, Inc. and Sandoz Inc.

3 Dec 2010

SAGE launches two new journals in Drug Safety, Hematology

SAGE Expands Therapeutic Advances series by launching two new journals in Drug Safety and Hematology. SAGE has extended its suite of Therapeutic Advances journals with the launch of a further two titles: Therapeutic Advances in Drug Safety, and Therapeutic Advances in Hematology.

3 Dec 2010

AstraZeneca announces FDA Advisory Committee meeting outcome for vandetanib NDA

AstraZeneca today announced the outcome of the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee meeting to discuss the New Drug Application (NDA) for AstraZeneca's investigational drug, vandetanib, for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer (MTC).

2 Dec 2010

FDA approves Sagent's general anesthetic midazolam

Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced U.S. FDA's approval of four presentations of midazolam injection, USP, a general anesthetic. Sagent expects to launch midazolam, which will be offered in latex-free vials, in 2011. According to 2010 IMS data, the annual U.S. market for injectable midazolam approximated $52 million.

2 Dec 2010

FDA approves IDE application to initiate Tryton Side Branch Stent System for coronary artery disease

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced U.S. Food and Drug Administration (FDA) conditional approval for an Investigational Device Exemption (IDE) application to initiate the pivotal trial to evaluate the Tryton Side Branch Stent System for the treatment of coronary artery disease.

2 Dec 2010

FDA panel rejects expansion of drug label

The New York Times: A Food and Drug Administration advisory committee on Tuesday rejected a bid to change the labels of two drugs to say they can reduce the risk of prostate cancer. "If the drugs were approved for that purpose, they would be only the second class of cancer-prevention drugs on the market."

2 Dec 2010

FDA approves Abiomed to begin MINI-AMI trial to evaluate Impella 2.5

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI).

2 Dec 2010

ROCHE, Baylor Research Institute partner in human immunology research

Baylor Research Institute (BRI), the research arm of Baylor Health Care System, announced today that it has formed a three-year partnership with Roche (SIX: RO, ROG; OTCQX: RHHBY) to jointly develop programs emerging from the human immunology platforms developed at the Baylor Institute for Immunology Research (BIIR), a component of BRI.

2 Dec 2010

Hybrigenics receives EUR 800,000 payment from Oseo

Hybrigenics (ALHYG), a bio-pharmaceutical group with a focus on research and development of new cancer treatments and a fully-owned subsidiary specialized in protein interactions services, today announces it has received EUR 800,000 as the second and last payment of a EUR 1.4 million refundable grant contract originally signed with France’s innovation agency, Oseo Innovation, in 2008.

2 Dec 2010

Denmark grants marketing authorization for SUMAVEL DosePro Needle-Free Delivery System

Zogenix, Inc. and Desitin Pharmaceuticals GmbH today announced that the Danish Medicines Agency of Denmark has approved the Marketing Authorization Application (MAA) for SUMAVEL® DosePro™ (sumatriptan injection) Needle-Free Delivery System. Denmark is the first country in Europe to grant marketing authorization for SUMAVEL DosePro for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.

2 Dec 2010

Research: Environmental bacteria compromises effectiveness of BCG vaccine

A new discovery may explain why a tuberculosis vaccine is not as effective for some people as anticipated, and potentially explains why other vaccines do not work as well for some as they do for others.

2 Dec 2010

European Commission approves Pfizer's SUTENT for pancreatic neuroendocrine tumors

Pfizer Inc. announced today that the European Commission has approved SUTENT (sunitinib malate) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (NET) with disease progression in adults.

2 Dec 2010

JAMA: OTC medications' dosing instructions for children adhere poorly to FDA guidelines

A recent Journal of the American Medical Association study indicates dosing instructions and dose delivery devices of over-the-counter medications for children poorly adhere to FDA guidelines.

2 Dec 2010

Study finds inconsistency in OTC medications for children

Instructions on boxes and bottles of over-the-counter (OTC) medicines for children in the United States are confusing and hard for parents to understand and follow, according to a study in the December 1 issue of JAMA.

2 Dec 2010

Patients with chronic constipation prefer Kristalose oral solution

Cumberland Pharmaceuticals Inc. today announced the publication of a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, compared to liquid lactulose products.

2 Dec 2010

Aspirin decreases plaque formations that cause heart attacks and strokes

Charles H. Hennekens, M.D., DrPH, the first Sir Richard Doll Research Professor in the Charles E. Schmidt College of Medicine at Florida Atlantic University, has published the results of A Randomized Trial of Aspirin at Clinically Relevant Doses and Nitric Oxide Formation in Humans in the current issue of the Journal of Cardiovascular Pharmacology and Therapeutics.

2 Dec 2010

CSC files IND application to commence Phase I study for Spinal Muscular Atrophy

California Stem Cell, Inc. (CSC) and Families of Spinal Muscular Atrophy (FSMA) announced today that CSC has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for approval to commence a Phase I safety study on a jointly-developed stem cell-derived motor neuron transplantation therapy for Spinal Muscular Atrophy (SMA) Type I.

2 Dec 2010

Baxter licenses Vero cell-based influenza vaccine technology to Takeda

Baxter International Inc. and Takeda Pharmaceutical Company Limited today announced that the parties have completed a Development, License and Technology Transfer Agreement. Under the terms of the agreement, Takeda and Baxter will expand upon their previously announced collaboration to bring Vero cell culture-based influenza vaccines to the Japanese market.

From Baxter International Inc. 2 Dec 2010

DOD awards $2.24 million grant to study keratin gel in peripheral nerve regeneration

Orthopaedic researchers at Wake Forest University Baptist Medical Center (WFUBMC) have been awarded a $2.24 million four-year grant from the U. S. Department of Defense (DOD) to study the use of keratin gel in the regeneration of damaged peripheral nerves, those in the hands, arms and feet.

2 Dec 2010