FDA experts back Allos' cancer therapy; Gloucester wins vote on CTCL therapy;

> In a key vote, an expert FDA panel backed Allos Therapeutics' new therapy for peripheral T-cell lymphoma by 10 to 4. Report

> The ODAC also voted in favor of Gloucester Pharmaceuticals' romidepsin to treat patients with cutaneous T-cell lymphoma. Release

< The FDA has approved Shire's Intuniv (guanfacine) extended release tablets for ADHD. Report

> New Leaf Venture Partners announced yesterday that it led a $30 million Series D financing round in Neuronetics, a medical device company. Release

> Endo Pharmaceuticals says that the FDA has extended its review period for the developer's testosterone drug candidate by three months. Report

> The U.S. Bankruptcy Court has approved Cornerstone Therapeutics' acquisition of the commercial rights to the antibiotic Factive(gemifloxacin mesylate) in North America and certain countries in Europe from Oscient Pharmaceuticals. Release

Pharma News

> Both plaintiff and defense have presented their arguments over Merck's Fosamax and its possible links to jawbone death. Now it's up to the jury to decide. Report

> Back in January, Pfizer set aside $2.3 billion to settle a Justice Department investigation. Details of the settlement have now been revealed. Report

> Another Japanese pharma has snapped up a U.S. drugmaker. This time, it's Dainippon Sumitomo Pharma, which will pay $2.6 billion for Sepracor mainly to get access to the latter's sales network. Dainippon will offer $23 per share in a tender that amounts to a 28 percent premium to Tuesday's closing price. Report

Vaccine News

> A human vaccine to guard against the Hendra virus, which recently caused the death of an Australian veterinarian, may be 15 years and one billion dollars away, the renowned scientist Ian Frazer tells Australia's News.com.au. Report

> Both Merck and GlaxoSmithKline face a big day in front of an FDA expert panel next week. Glaxo will be making its case for Cervarix, a widely used vaccine designed to guard against cervical cancer that's been blocked from the U.S. market. Report

> Racing to produce a huge quantity of vaccine to fight an expected tsunami of swine flu cases this fall, Novartis says that a single low dose of its Celtura jab produced an immune response sufficient to protect the volunteers enrolled in a small trial. Report

> China's Sinovac Biotech has won swift approval to begin manufacturing the country's first swine flu vaccine. And the regulatory green light will likely be followed up in short order with a second approval. Report

And Finally.... Both Merck and GlaxoSmithKline face a big day in front of an FDA expert panel next week. Glaxo will be making its case for Cervarix, a widely used vaccine designed to guard against cervical cancer that's been blocked from the U.S. market. And Merck, which has been selling its HPV vaccine in the U.S. for three years, will be touting data that supports its argument for using Gardasil to protect boys. FierceVaccines

Suggested Articles

A few years ago, one of our Fierce editors met a Big Pharma R&D chief for the first time. “You’re the ones with the scary name,” he joked.

Pfizer's eczema hopeful has been building its case to challenge Sanofi and Regeneron's Dupixent, but safety issues could stand in its way.

Cedrik Britten, M.D., becomes the biotech’s new chief medical officer to help run its adoptive cell therapy and TCR bispecifics platform.