Shares of Cell Therapeutics Inc. tumbled 39.6 percent after FDA briefing documents, emerging ahead of Wednesday's advisory panel, suggested that the company's abbreviated pivotal study of pixantrone might not be enough to warrant the drug's accelerated approval in relapsed/ refractory aggressive non-Hodgkin's lymphoma. (BioWorld Today)
With promising early data and a clear Phase III pathway for its GALNS drug in a rare lysosomal storage disorder, BioMarin Pharmaceuticals Inc. said it is no longer in critical need of late-stage assets to fill out its pipeline. (BioWorld Today)
With simultaneous filings for uveitis drug Luveniq in the U.S. and Europe, Lux Biosciences Inc. has done what few small, private biotechs have managed in today's tough economy: get a drug to market without the help of public funding or a big pharma partner. (BioWorld Today)
It didn't take long for 2007 start-up Flexion Therapeutics to begin attracting venture financing and prospective pharma partners, all drawn to the Woburn, Mass.-based firm's unique business model aimed at giving deprioritized early stage compounds a second chance. (BioWorld Today)