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FDA approves Cephalon's REMS for GABITRIL

Cephalon, Inc. today announced that a Risk Evaluation and Mitigation Strategy (REMS) for its antiepileptic medication GABITRIL(R) (tiagabine hydrochloride) has been approved by the U.S. Food and Drug Administration (FDA). The GABITRIL REMS consists of a Medication Guide to inform patients about the potential risks associated with the use of GABITRIL.

15 Oct 2010

Lantheus announces Canadian launch of ABLAVAR injection

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced the Canadian launch of ABLAVAR (gadofosveset trisodium injection), a unique, injectable magnetic resonance angiography (MRA) blood pool imaging agent.

15 Oct 2010

Moores Cancer Center files IND application for topical NexACT-based formulation

Apricus Biosciences, backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT drug delivery technology and internal pipeline through out-licensing partnerships, today announced that the Moores Cancer Center at the University of California San Diego (UCSD) has filed an Investigational New Drug Application with the U.S. Food & Drug Administration ("FDA") for approval to test Nupen, Apricus Bio's proprietary, topical NexACT-based formulation of filgrastim (Neupogen).

15 Oct 2010

FDA approves Gamunex-C for primary immunodeficiency treatment

Talecris Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).

15 Oct 2010

Acetadote Injection is now commercially available in Australia

Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd. today announced that Acetadote (acetylcysteine) Injection, an injectable product used to treat acetaminophen (paracetamol) overdose, is now commercially available in the Australian market. Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, has an exclusive license from U.S.-based Cumberland Pharmaceuticals to market and distribute the product in Australia.

15 Oct 2010

NanoViricides files financial year end annual report with SEC

NanoViricides, Inc. reports that it has filed its financial year end annual report (Form 10K) with the Securities and Exchange Commission (SEC) yesterday in a timely manner.

14 Oct 2010

Labopharm, Paladin Labs expand commercial relationship

Labopharm Inc. and Paladin Labs Inc. today announced they have expanded their commercial relationship through three licensing and distribution agreements under which Paladin will distribute two of Labopharm's products in certain jurisdictions.

14 Oct 2010

Top biopharma leaders to share strategies at Windhover's 2nd PharmAsia Summit

Elsevier Business Intelligence, publisher of PharmAsia News, IN VIVO and The Pink Sheet, today announced the agenda for Windhover's 2nd PharmAsia Summit (Oct. 25-26). This year's Summit will bring top biopharma leaders from Asia and the U.S. to San Francisco to share what works and what doesn't in China, India, Japan and the Pacific Rim.

14 Oct 2010

Marijuana legalization in California will marginally impact revenues of Mexican drug trafficking organizations

Legalizing marijuana in California will not dramatically reduce the drug revenues collected by Mexican drug trafficking organizations from sales to the United States, according to a new RAND Corporation study.

14 Oct 2010

Dangers of over the counter 'natural' slimming products

The desire for a quick-fix for obesity fuels a lucrative market in so-called natural remedies. But a study of medical records in Hong Kong revealed 66 cases where people were suspected to have been poisoned by a "natural" slimming therapy. In eight cases the people became severely ill, and in one case the person died. The study is published today in the British Journal of Clinical Pharmacology.

14 Oct 2010

$FDA warns of risk of atypical thigh bone fracture in patients taking bisphosphonates$

FDA warns of risk of atypical thigh bone fracture in patients taking bisphosphonates

The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk. Bisphosphonates inhibit the loss of bone mass in people with osteoporosis.

14 Oct 2010

Study finds hemostatic powder effective in treating 95% of patients with bleeding peptic ulcers

A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau.

14 Oct 2010

Risingsun signs consent decree to stop selling unapproved drugs

The U.S. Food and Drug Administration today announced that Toby McAdam and Greta Armstrong, doing business as Risingsun Health and The Center for Complimentary and Alternative Health of Livingston, Montana, have signed a consent decree that prohibits them from manufacturing and selling unapproved new drugs and adulterated or misbranded dietary supplements in violation of the law.

14 Oct 2010

World's third rectal microbicide trial launched in Pittsburgh

The world's third rectal microbicide trial launched in Pittsburgh, Pennsylvania today, with sites preparing to open in Boston, Massachusetts, and Birmingham, Alabama soon. Scientists will test the rectal safety and acceptability of tenofovir gel, a microbicide developed for vaginal use that has shown promise for preventing HIV through vaginal intercourse. Depending on the outcome of this new study, tenofovir gel could be further evaluated to determine if it can reduce the risk of HIV among both men and women who engage in receptive anal intercourse.

14 Oct 2010

GSK to expand donation of albendazole medicine to treat children with STH risk

At the launch of the World Health Organization's (WHO) first report on Neglected Tropical Diseases today, GSK announced a new five year commitment to expand the donation of its medicine albendazole to treat children at risk of intestinal worms, known as soil-transmitted helminths (STH).

14 Oct 2010

Workshop to focus on FDA process that grants orphan drug designation

The U.S. Food and Drug Administration has scheduled the third in a series of workshops on orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process for Nov. 4-5, 2010, in Lansdowne, Va.

14 Oct 2010

Justices wrestle with issue of protecting vaccine makers

The Supreme Court is grappling with the question of how much protection the 1986 National Childhood Vaccine Injury Act was meant to provide vaccine manufacturers against lawsuits. The case involves Hannah Bruesewitz, whose parents claim that a Wyeth-manufactured D.T.P. vaccine she received as an infant in 1992 led to developmental problems.

14 Oct 2010

Labopharm announces European approval of twice-daily tramadol-acetaminophen

Labopharm Inc. today announced its twice-daily tramadol-acetaminophen has received a positive opinion under the European Union Decentralized Procedure in eight countries (Czech Republic, Iceland, Ireland, Poland, Portugal, Slovakia, Slovenia and Spain). Marketing Authorization will be granted in each country subject to the approval of translations of the Summary of Product Characteristics (SPC) and other labeling documents.

14 Oct 2010

Stop TB Partnership launches Global Plan to Stop TB 2011-2015

The WHO's Stop TB Partnership "laid out a new plan on Wednesday to combat tuberculosis and the nearly 2 million deaths it causes each year," Reuters reports.

14 Oct 2010

Scientists suggest lemon-lime soft drink can improve effectiveness of oral anticancer drug

Experiments with an artificial stomach suggest that a popular lemon-lime soft drink could play an unexpected role in improving the effectiveness of an oral anticancer drug. The experiments produced evidence that patients will absorb more of the unnamed drug, tested in Phase I in clinical trials, when taken with "flat" or degassed Sprite. The study appears in ACS' Molecular Pharmaceutics, a bi-monthly journal.

14 Oct 2010