Sanofi may face suit over alleged vaccine injury; Bayer plots 2010 Betaferon launch in China;

> Sanofi-Aventis' vaccine unit may face a lawsuit originally filed against its distributor by a patient who claims to have suffered severe brain damage from a company product. Report

> Bayer plans to start selling its Betaferon multiple sclerosis drug in China by the middle of next year. Release

> Large-scale government tenders for generic medicines are threatening the future of the off-patent pharmaceuticals industry, the new president of the trade body has warned. Report

> Belgian pharmaceutical group UCB plans to issue a bond of around 500 million euros ($753.6 million), possibly as early as today. Report

> Eli Lilly's antidepressant drug Cymbalta got the FDA nod for expanded use as a maintenance treatment in generalized anxiety disorder. Release

> European pharmaceutical stocks were raised to "overweight" from "neutral" by UBS strategists on the prospect of a recovery next year. Report

> Medco Health Solutions and Coventry Health Care will work together to see if they can reduce health care costs for senior citizens by addressing factors like home safety, diet and medication use. Release

> A former executive of a Johnson & Johnson devices subsidiary was charged with conspiracy to corrupt in connection with payments to Greek medical professionals. Report

Biotech News

> Roche rolled out data from a pair of Phase III trials of its experimental diabetes drug taspoglutide, saying that researchers have nailed down its superiority to Merck's blockbuster Januvia. Report

> Hemispherx BioPharma was dealt a heavy blow yesterday, watching its already battered share price plunge 44 percent after the developer announced that the FDA demanded to see more information from a new trial of its therapy for chronic fatigue syndrome before making a final decision on the NDA. Hemispherx article

> Novogen has severed ties with CEO and Managing Director Christopher Naughton, who also was terminated as CEO of the company's oncology subsidiary Marshall Edwards. Report

> Dyax shares rocketed up 38 percent yesterday evening after the developer announced that the FDA had approved its lead drug Kalbitor (also known as ecallantide or DX-88) for patients with hereditary angioedema. Dyax report

Manufacturing News

> The FDA's mighty efforts to become a more transparent government agency, beginning with a transparency task force, convened in June, are yielding results, says blogger Mark Senak. His transparency metric of advisory committee rosters that include links to committee member CVs has seen a rise to 77 percent, up from 50 percent. Report

> FDA reviewers can look forward to a break in their daily routine for education on advanced pharmaceutical manufacturing and technology. Report

> Japanese drug officials are visiting Canada following GlaxoSmithKline's advice to the Great White North to hold the remaining 15,000 doses of a batch of swine flu vaccine. GSK wants to investigate reported cases of anaphylaxis associated with the drug, Arepanrix. Japan's interest is in a yet-to-be-delivered stockpile shipment. Report

> "Do not enter into supply agreements with companies that do not meet acceptable standards, and terminate agreements with companies that do not maintain acceptable standards." So says Gerry Migliaccio, senior VP for global manufacturing at Pfizer, in a Pharmaceutical Technology interview. Report

> The on-again, off-again efforts of the FDA's office of combination products are back on again. The OCP's good manufacturing practices proposal is intended to clarify confusion surrounding approvals of products that comprise combinations of drugs, biologics and devices. The current work takes the place of stalled draft guidance begun in 2004. Report

> Cross-contamination has tripped up API maker ZaCh Systems in France. The company was cited in an October warning letter for lacking procedures necessary to prevent cross-contamination. Beyond the contamination, however, the FDA cited the company for its initial inaction and then slow follow-up after the contamination had been discovered in a drug ingredient that had been released for distribution. Report

And Finally... Half of all patients in intensive care units around the world have infections, and more than 70 percent are being given antibiotics--a trend that could help more drug-resistant superbugs emerge. Report