BioPharma Today

Cephalon Settles Off-Label Charges With $425 Million Payout

Full article reprinted from "The Pink Sheet Daily"- September 30, 2008

Find out why Cephalon will plead guilty to a misdemeanor violation and pay $425 million to resolve criminal charges brought by the U.S. Department of Justice and a separate civil suit alleging the company marketed three of its drugs off-label from January 2001 through at least 2006.

Ranbaxy’s Troubles Continue – WHO Plans “Extra-ordinary” Action To Confirm Safety Of Prequalified Drugs

Full article reprinted from "PharmAsia News" - September 30, 2008

Find out why The cascading effect of U.S. FDA's enforcement action against India's largest drug maker Ranbaxy has reached the World Health Organization. On its website, WHO has observed that several inspections of Ranbaxy's Paonta Sahib site - most recently in June 2008 - revealed noncompliance with WHO good manufacturing practices standards.

Medicare Price Negotiation -- Waiting for the Other Shoe to Drop

Full article reprinted from "The RPM Report" -September 30, 2007

Find out why At present, the federal government is prohibited from negotiating outpatient prescription drug prices with pharmaceutical companies on behalf of Medicare Part D...

Tighter Inspection Provisions In Dingell Safety Bill Could Follow Ranbaxy Alert

Full article reprinted from "The Tan Sheet" -September 30, 2008

Find out why House Energy and Commerce Committee Chairman John Dingell likely will strengthen FDA mandates proposed in his evolving global drug safety bill in light of the agency's import alert for Ranbaxy products, including an OTC drug.

FDA Revisits Wellbutrin Generics – Again; Will Teva Fund A High-Dose Study?

Full article reprinted from "The Pink Sheet" -September 30, 2008

Read about why the FDA considers how best to address continued concerns about generics for Wellbutrin XL (bupropion extended-release tablets), one issue it may wrestle with is whether it should conduct bioequivalence studies at the highest dose, 300 mg, which has a higher risk of seizures.

Kowa and Teva Partner For 50-50 Stake In Japanese Generic Firm

Article preview from "PharmAsia News" - September 24, 2008

Find out why Japanese drug maker Kowa said Sept. 24 that it had signed a definitive agreement with Israel generic manufacturer Teva Pharmaceutical to share a 50-50 stake in a generic manufacturer in Japan to take advantage of a growing Japanese generics market.

ARCA Files NDA For Bucindolol; First Genetically Targeted CV Therapy?

Full Article Reprinted from "The Pink Sheet" DAILY- September 23, 2008

Read about why the FDA has accepted an NDA for Gencaro (bucindolol), which could be the first cardiovascular drug approved with an accompanying pharmacogenomic test, ARCA Biopharma said Sept. 23.

DoJ, Congress Want Ad Oversight: FDA Sounds Ready To Respond

Full Article Reprinted from The Pink Sheet - September 17, 2008

Find out why the Department of Justice's level of interest in drug industry promotional issues seems to be increasing, FDA Division of Drug Marketing, Advertising & Communications Director Tom Abrams told the Food & Drug Law Institute advertising and promotion conference Sept. 8.

Fablyn Panel Finds Mortality Trend Inconclusive, But Pfizer Ready With A Plan

Full article reprinted from "The Pink Sheet" - September 15, 2008

FDA's Advisory Committee for Reproductive Health Drugs did not reach a clear conclusion on whether Pfizer's osteoporosis drug Fablyn has a mortality issue. Find out how Pfizer already has a proposal for a post-market study to provide a definitive answer.

European Markets for Benign Prostatic Hyperplasia Therapies

Full Article Reprinted from Start-Up - September 05, 2008

Find out why investor interest in the urology space waxes and wanes...