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Merck to pay millions over Mass. allegations of inflated wholesale rate

Bloomberg Businessweek: A Massachusetts court ordered the drug maker Merck to pay $4.6 million in damages for inflating wholesale prices for generic asthma drugs. "Massachusetts claimed the companies reported inflated wholesale acquisition-cost prices for the generics, and that MassHealth, the state component of the Medicaid program, would rely on those prices for reimbursements" (McQuillen, 9/30).

1 Oct 2010

Medicago announces official groundbreaking ceremony for U.S. plant-based commercial grade vaccine facility

Medicago U.S.A. Inc., a wholly owned subsidiary of Medicago Inc., a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that company executives, along with U.S. Senator Kay Hagan (D-NC) and U.S. Congressman David Price (D-NC), are holding an official groundbreaking ceremony this morning for its U.S. plant-based commercial grade vaccine facility in Research Triangle Park, North Carolina.

1 Oct 2010

Noven acquires global rights to Daytrana from Shire affiliates

Noven Pharmaceuticals, Inc. today announced that it has completed the acquisition of global rights to Daytrana® (methylphenidate transdermal system) from affiliates of Shire plc.

1 Oct 2010

USFDA grants Sun Pharma tentative approval for generic Stalevo ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Orion's Stalevo® tablets.

1 Oct 2010

Cortex regains global rights to AMPAKINE compounds for treatment of schizophrenia and depression

Cortex Pharmaceuticals, Inc. announced that it has regained worldwide rights to develop and commercialize its AMPAKINE® compounds for the treatment of schizophrenia and depression.

1 Oct 2010

Mylan subsidiary launches Bupropion Hydrochloride Extended-release Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Bupropion Hydrochloride Extended-release Tablets USP, (XL), 150 mg and 300 mg (Once-Daily), the generic version of GlaxoSmithKline's antidepressant Wellbutrin XL®.

1 Oct 2010

FDA issues Complete Response Letter for Teva's Neutroval BLA

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Application (BLA) for Neutroval™ (granulocyte colony-stimulating factor) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

1 Oct 2010

First nationwide Safe Medication Disposal Program launched

Walgreens has launched the first ongoing, nationwide Safe Medication Disposal Program, a safe and environmentally responsible way to dispose of unused or expired medications.

1 Oct 2010

FDA takes action against unapproved single-ingredient oral colchicine

The U.S. Food and Drug Administration took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

1 Oct 2010

HIV/AIDS researchers, government officials track progress, forecast challenges for HIV vaccine development

More than 1,000 researchers, government officials and advocates are gathering in Atlanta this week to discuss the progress and future challenges in the development of a vaccine that protects against HIV, FierceVaccines reports (Carroll, 9/29). The AIDS Vaccine 2010 meeting, which kicked off Tuesday, will run through Friday, according to the website for the meeting (undated).

1 Oct 2010

Study demonstrates rufinamide therapy is effective in reducing partial seizure frequency

Researchers from the Arkansas Epilepsy Program found treatment with rufinamide results in a significant reduction in seizure frequency compared with placebo, for patients with uncontrolled partial-onset seizures (POS).

1 Oct 2010

APhA urges consumers to discuss proper medication usage with pharmacists

In honor of American Pharmacists Month, the American Pharmacists Association (APhA) encourages consumers to hold an open dialogue with their pharmacists about a growing problem in the United States, the proper usage of and adherence to medications.

1 Oct 2010

Biologics can achieve great success - but at great cost

The Wall Street Journal's Health Blog: Insurers want to know why biologic drugs are so expensive. "UnitedHealth Group's Prescription Solutions unit hosted a roundtable this morning in midtown Manhattan focusing on a topic that's hot right now: the rocketing growth of spending on biologic drugs.

1 Oct 2010

Progressive Medical updates 2010 Drug Spend Analysis

Progressive Medical, Inc. announced today the release of a mid-year update to its 2010 Drug Spend Analysis. This report, which supplements the report released in April, provides clients with an update in workers' compensation medication spending from January 2010 through June 2010 and key factors that affect future expenditures, including inflation, utilization and product mix.

30 Sep 2010

Tengion presents Neo-Kidney Augment development program at ISCT Symposium

Tengion, Inc. presented new research data yesterday in a podium presentation at the 2nd Annual Symposium on Stem Cell Translation of the International Society for Cellular Therapy (ISCT) in San Francisco. The presentation highlighted new results from Tengion's Neo-Kidney Augment development program demonstrating success with an autologous cellular therapy approach to kidney regeneration in a rodent model of obesity, diabetes and hypertension.

30 Sep 2010

Canadian Cancer Society alarmed by government inaction to establish national catastrophic drug insurance program

A large majority of Canadians - 85 per cent - say if they were diagnosed with cancer the cost of drugs would have a negative impact on their personal finances, according to poll results released today by the Canadian Cancer Society.

30 Sep 2010

Genotoxic impurities in prescription drugs

Drug manufacturers have been adjusting to strict new government standards that limit the amount of potentially harmful impurities in medicine, according to the cover story of the current issue of Chemical & Engineering News (C&EN), ACS' weekly newsmagazine. The impurities are "genotoxic," capable of damaging the DNA in genes.

30 Sep 2010