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FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Celsion Corporation, a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.

4 Oct 2010

Mylan subsidiary receives FDA approval for Fludarabine Phosphate Injection ANDA

Mylan Inc. today announced that its subsidiary Bioniche Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fludarabine Phosphate Injection USP, 25 mg/mL, packaged in 50 mg/2 mL Single-dose Vials. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Teva Parenteral's Fludarabine Phosphate Injection USP, 25 mg/mL, a chemotherapy medication for B-cell chronic lymphocytic leukemia (CLL).

4 Oct 2010

Merck to appeal Massachusetts federal court jury verdict

Merck & Co., Inc. today said it will vigorously appeal a Massachusetts federal court jury verdict concerning allegations that a former subsidiary of Schering-Plough Corporation, Warrick Pharmaceuticals, caused the Commonwealth of Massachusetts to overpay local pharmacists for prescriptions of albuterol. Merck and Schering-Plough merged in November 2009. Warrick ceased operations prior to the merger, in 2008.

4 Oct 2010

NIH announces it will share IP rights to some AIDS drugs in UNITAID Patent Pool

The NIH announced Thursday it will share intellectual property rights on some AIDS drugs in a patent pool designed to make treatments more widely available to the poor, Reuters reports.

4 Oct 2010

Study shows no difference between Bevacizumab and Ranibizumab efficacy in treating AMD

Researchers from Boston University School of Medicine (BUSM) and the VA Boston Healthcare System have conducted a study that failed to show a difference in efficacy between Bevacizumab (Avastin) and Ranibizumab (Lucentis) for the treatment of age-related macular degeneration (AMD).

4 Oct 2010

New American Therapeutics acquires U.S. rights to market Denavir drug

New American Therapeutics, Inc., announced today that it acquired all U.S. rights to manufacture, market and sell the antiviral topical drug Denavir owned by Novartis.

4 Oct 2010

Report says drugmakers failing to give Medicaid adequate price data

Drug manufacturers often flout a federal law that requires them to provide the government with pricing data needed to calculate discounts on medications prescribed for poor people under Medicaid, federal investigators say in a new report.

4 Oct 2010

WHO says polio outbreak in Angola must be stopped to avoid 'international consequences'

A polio outbreak in Angola, which started in 2007, could have "international consequences" if it is not stopped, Sona Bari, the WHO's spokesperson on polio eradication, said on Friday, Reuters reports.

4 Oct 2010

Icagen updates status of ICA-105665 clinical development program

Icagen, Inc. today provided an update on the status of the clinical development program for ICA-105665. As previously reported, the Company recently suspended enrollment in the photosensitivity study of ICA-105665.

3 Oct 2010

Sulindac drug derivative effective in preventing colon cancer: Research

Researchers in the Division of Cancer Prevention, Department of Medicine, at Stony Brook University have discovered that a novel derivative of sulindac, a non-steroidal anti-inflammatory drug (NSAID) known to prevent colon cancer, is more effective and safer than sulindac in preventing colon cancer in animals. The study results are reported in the October issue of the journal Gastroenterology.

3 Oct 2010

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