BioPharma Today

Coming in Monday's "The Pink Sheet" DAILY - J&J Reaches Settlement with DoJ for Off-Label Topamax Promotion

NeurogesX brings in $40 million to help with U.S. commercialization of recently launched Qutenza through a royalty financing agreement with Cowen Healthcare Royalty Partners.

Overcoming Disaster: What Biotechs Do When A Lead Asset Fails

Drug candidates fail at an alarming rate. For biotechs that seemingly have their entire future - and tens of millions of investor dollars - tied up in one compound or one clinical trial, failure of a lead asset can mean certain, sudden death. Meet four small companies that had another plan.

Latest News from "The Pink Sheet" DAILY - Dendreon Set To Ship Provenge Soon

Dendreon Set To Ship Provenge Within A Week

Demand expected to exceed supply as company builds manufacturing capacity.   read more

Editors' Picks from the World Press

Pipeline/RD News

• Research links gene to obsessive-compulsive disorder in mice
• College professor's genomic data reveal health risks
• Turmeric component aids ovarian cancer treatment, study shows
• Enzyme linked to heart risk might boost interest in GSK drug

Business Finance

• Celtic Therapeutics licenses amyloidosis drug from Bellus Health
• CEO says Novartis will not outsource RD, sales in China

Government Legal News

• 2 JJ units face $81 million penalty for Topamax marketing
• Schwarz Pharma will pay $22 million to settle government's claims
• Court upholds dismissal but voices concern about "pay-to-delay" deals
• Congressional investigation cites FDA error in heparin crisis

Coming in Friday's "The Pink Sheet" DAILY -- Bayer, AstraZeneca, Bristol Report Earnings

Drug companies looking to bring biosimilars to the U.S. market will use existing regulatory pathways like 505(b)(2) or an outright Biologics Licensing Application over a new regulatory pathway developed out of health care reform legislation because of provisions in the latter that favor brands, Sandoz Division Head Jeff George said in an interview.

Latest News From "The Pink Sheet" DAILY - Glaxo Unimpeded By Health Care Reform

Merck Names Ken Frazier President

Editors' Picks From The World Press

Pipeline/RD News

• Study shows melanized nanoparticles' capability in radiation protection

Coming In Thursday's "The Pink Sheet" DAILY - Avandia On Capital Hill

Avandia returns to Capitol Hill: Appropriations Subcommittee hears from critics of diabetes drug, but not FDA.

Charles River's WuXi PharmaTech Acquisition - Latest From PharmAsia News

Charles River-WuXi PharmaTech Deal Transforms China's CRO Landscape

04/28/10 7:01 GMT

Enforcement on Steroids: FDA Delivers Twice the Drug GMP Warning Letters

Enforcement on steroids: As expected, FDA enforcement went into overdrive last year. The warning letter rate doubled and punishments were swift and harsh.