New Drug Application news from FierceBiotech

> Shares of Adolor surged on the news that the FDA's Gastrointestinal Drugs Advisory Committee will review the new drug application for the pain drug Read more...

Advanced Life Sciences is touting data from a recent trial of its antibiotic cethromycin. The therapy produced positive data that it can fight pneumonuia effectively and safely and demonstrated an Read more...

MediQuest Therapeutics is reporting positive results from a Phase III trial of MQX-503, a topical therapy for Raynaud's Disease. Raynaud's--a stinging constriction of blood flow to hands, feet and Read more...

Cephalon is touting Phase III results of its non-Hodgkin's lymphoma drug Treanda. In the trial, 100 patients who were not responding to Genentech and Biogen Idec's Rituxan were given Treanda. The Read more...

At the American Society for Bone and Mineral Research Annual Meeting, Wyeth presented strong Phase III data for its osteoporosis drug. Bazedoxifene 20 mg and 40 mg significantly reduced the risk of Read more...

Analysts were surprised to hear that GlaxoSmithKline was handed a "not approvable" letter for the supplemental drug application for the 500/50 strength of Advair Diskus for patients with chronic Read more...

> ThermoGenesis has promoted COO William Osgood to the CEO's post. The transition was triggered by founder Phil Coelho's move to the new position of chief technology architect. Read more...

Stiefel Laboratories announced that the FDA has approved its new drug application for Extina Foam, 2 percent for the treatment of seborrheic dermatitis. The approval, which the company received June Read more...

Shares of Switzerland's Arpida soared more than 25 percent this morning after the company announced that its superbug drug iclaprim performed as well as a Read more...

Shares of Momenta took a hit after the company warned that its development of a generic version of Sanofi's blood thinner Lovenox is likely to take longer than expected. Shares slid 15 percent on the news that the regulatory review of its abbreviated new drug application would take longer than the 18 to 24 months originally expected. Momenta is developing M-Enoxaparin with Sandoz, the generic arm of Novartis. Momenta is considered one of the key players in the development of a new …

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