Stats show weakness in Q4 NDAs; FDA wants more info on Sanofi's insomnia drug; Juvaris raises $25M;

> The FDA has told Sanofi-Aventis that it will need to see more information on its experimental insomnia drug eplivanserin before it can be approved. The pharma giant says that the agency is looking for additional information covering the drug's "benefit-risk." Report

> For drug applications, third-quarter submissions appear to fare far better than those made in Q4. Employee-compensation incentives may be driving the "sloppier" fourth-quarter applications, say presenters at the Regulatory Affairs Professionals Society conference. Report

> Adjuvant vaccines developer Juvaris BioTherapeutics has completed the first close of a $25 million Series B round. The Burlingame, CA-based company says it will use the capital to advance its technology platform and carry its lead adjuvant, JVRS-100, into mid-stage clinical development for seasonal and pandemic flu. Report

> Cel-Sci and Novavax, which are both working on swine flu-related products, are planning to raise a combined $30 million in new financing. Report

> Ascent Therapeutics is putting its drug development work on display at a conference in Zurich, Switzerland, touting its lead therapy as a potential rival to Genzyme's cancer drug Mozobil. Story

Pharma News

> A drug that's been in use for more than half a century will now have a black box warning. Injectable promethazine--a prescription generic used as a sedative and to treat nausea and vomiting--will now come with information declaring risk of serious tissue injury when administered improperly. Report

> Rituxan got out of school early by completing the requirements of a Phase III trial during an early analysis. Follicular lymphoma patients who received the drug alone following its use with chemotherapy lived longer without disease progression than did those who stopped taking the drug after the chemo/drug therapy, say Genentech and Biogen Idec. Story

>  Merck and Wellcome Trust have created the MSD Wellcome Trust Hilleman Laboratories, a not-for-profit R&D venture focused on affordable vaccines to prevent diseases common in low-income countries. Report

Vaccine News

> A federal judge has tossed Emergent BioSolutions' attempt to force Protein Sciences into bankruptcy, but Emergent isn't about to give up on its long-running fight with Protein Sciences following the collapse of their merger deal. Report

> Once public health officials start their mass swine flu vaccination campaigns in October, they'll be bracing for a deluge of complaints about adverse events--most of which won't have anything to do with the vaccine. Report

> The long-awaited endorsement of GlaxoSmithKline's HPV vaccine Cervarix is widely expected to pave a short path to formal FDA approval. But Merck isn't sounding all that concerned that its vaccine, Gardasil, will finally face head-to-head competition in the world's richest drug market. Item

And Finally... An experimental gene therapy proved effective in spurring full color vision in monkeys that had never before been able to tell green from red. And the same approach could treat color blindness and other ailments in people. Report