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FDA approves NUEDEXTA capsules for pseudobulbar affect

AVANIR Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.

30 Oct 2010

Teflaro receives FDA approval for treatment of bacterial infections

The U.S. Food and Drug Administration today approved Teflaro (ceftaroline fosamil), an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

Drug and device makers face new taxes, fees

A Fox Business report shows the health overhaul is cutting deeper into drug and device makers' profits than many expected. Research & development programs are already being drastically scaled back.

30 Oct 2010

Pneumonia vaccination increases among older Americans, but still falls short of Healthy People 2010 goal

Between 2000 and 2007, the proportion of Americans age 65 and older who were vaccinated against pneumonia increased from 53 percent to 58 percent, but the rate fell far short of the Healthy People 2010 goal of 90 percent for pneumonia vaccinations in that age group, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

29 Oct 2010

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

29 Oct 2010

DiaGenic third quarter income increases from NOK -9.3 million to NOK -9.6 million

DiaGenic: The interim report for the third quarter 2010 was approved by the Board of Directors on 28 October 2010.

29 Oct 2010

ACADIA and BLS enter agreement to conclude pimavanserin collaboration

ACADIA Pharmaceuticals Inc. today announced that it has entered into an agreement with Biovail Laboratories International SRL ("BLS"), a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc., pursuant to which ACADIA and BLS have agreed to conclude their previously established collaboration to develop and commercialize pimavanserin in the United States and Canada.

29 Oct 2010

PHARMABIZ.com examines India’s push for clearer definition of counterfeit, substandard medicines

India has taken the lead to get together a number of generic drug-producing nations to call for better definitions to ensure quality, strengthening of regulatory authorities in the respective countries, and bringing focus of the world to public health instead of intellectual property, PHARMABIZ.com writes in an article that examines the recent meeting of leaders from Brazil, India and South Africa on issues regarding counterfeit medicines.

29 Oct 2010

VIVUS receives FDA CRL for QNEXA NDA

VIVUS, Inc. announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA® (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

29 Oct 2010

Nursing homes struggle to allow seniors use of medical marijuana

The New York Times: As states begin embracing medical marijuana they are also grappling with how they allow or don't allow seniors in nursing homes to use it. "The prospect has just begun to raise difficult questions for administrators and state regulators.

29 Oct 2010

FDA approves Sprycel for treatment of adults with Ph+ CP-CML

The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

29 Oct 2010

Pfizer announces approval of Lyrica capsules for peripheral neuropathic pain

Pfizer Inc announced that the Japanese Ministry of Health, Labour and Welfare approved Lyrica (pregabalin) capsules for the treatment of peripheral neuropathic pain. This follows the recent approval in Japan of Lyrica for the treatment of postherpetic neuralgia on April 16, 2010. Lyrica is the first medication approved for peripheral neuropathic pain in Japan where it is co-promoted with Eisai Co., Ltd.

29 Oct 2010

Latuda tablets receive FDA approval for treatment of adults with schizophrenia

The U.S. Food and Drug Administration today approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

29 Oct 2010

Tenofovir gel to prevent HIV transmission nearing approval

Anti HIV drug Tenofovir in its gel form is to be fast-tracked for approval by the US FDA. The announcement was made by Conrad, a nonprofit scientific organization based in Arlington, Virginia that works with reproductive health.

28 Oct 2010

Pro-Pharmaceuticals ships first commercial order of DAVANAT to PROCAPS in Colombia

Pro-Pharmaceuticals, Inc., the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced it has shipped its first commercial order of DAVANAT® to PROCAPS S.A., a large, international pharmaceutical company based in Barranquilla, Colombia. The $200,000 shipment of DAVANAT® will be used by PROCAPS to qualify its vial filling process.

28 Oct 2010

CCS presents new 2010 Atrial Fibrillation Guidelines

The Canadian Cardiovascular Society (CCS) presented its new 2010 Atrial Fibrillation Guidelines, the first update in six years, at the Canadian Cardiovascular Congress (CCC) in Montreal.

28 Oct 2010

Federal Government seizes prescription and OTC drug products from Tri-Med Labs

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized articles of prescription and over-the-counter (OTC) drug products from Tri-Med Laboratories Inc. in Somerset, N.J. earlier this month. The seizure warrant, issued by the U.S. District Court for the District of New Jersey and unsealed this week, shows the drugs are unapproved and adulterated new drugs.

28 Oct 2010

Essential Pharmaceuticals to commence sales of cell media products acquired from Lifeblood Medical

Essential Pharmaceuticals, LLC, a private company dedicated to providing specialty reagents and solutions to the life sciences market, announced today that the Company will commence sales and distribution of three distinct animal-component-free products: serum replacement, cryopreservation and clinical pathology media, formerly sold under the LiforCell® name.

28 Oct 2010

B. Braun initiates voluntary recall of heparin injection products

B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of a lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because additional testing of retained crude heparin samples used by SPL to manufacture this single API lot indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant.

From B. Braun Melsungen AG 28 Oct 2010

Health Canada approves PRADAX anticoagulant for stroke prevention in AF patients

Boehringer Ingelheim Ltd. today announces that Health Canada has granted approval of PRADAX (dabigatran etexilate), an oral anticoagulant for the prevention of stroke and systemic embolism in adults with atrial fibrillation in whom anticoagulation is appropriate. PRADAX is the first innovative drug approved in Canada in more than two decades to reduce the risk of stroke in Canadians with atrial fibrillation.

28 Oct 2010