Well-heeled venture capital firm Venrock has pieced together a 7th fund, banking $450 million in new investments as it sets out to grow its portfolio of promising startups.
Vertex' patient pool for cystic fibrosis drug Kalydeco is getting wider--250 patients wider, to be specific. The European Medicines Agency has green-lighted the drug--originally approved for CF patients with at least one copy of the G551D mutation--for 8 additional mutations, spelling new revenue potential for the orphan drugmaker.
Stakeholders unleashed competing reactions to FDA's long-anticipated move towards regulating laboratory developed tests announced July 31, reflecting the financial and political fault lines of the proposed framework.
A group of FDA advisers has given its blessing to a previously rejected immunodeficiency treatment from Baxter and Halozyme Therapeutics, setting the stage for an approval after years of delay.
The FDA approved Boehringer Ingelheim's COPD treatment Striverdi Respimat, a once-a-day inhaler the German drugmaker hopes can contend in a crowded respiratory market.
FDA announced July 31 that it intends to issue a draft guidance soon that would require moderate and high-risk diagnostics to obtain 510(k) or PMA approval, regardless of their place of origin, putting an end to a battle to regulate laboratory-developed tests that's been waged for several years.
The FDA's Gastroenterology & Urology Devices panel came down firmly against EDAP's Ablatherm system for treating low-risk, localized prostate cancer. The panel voted 9-0 on the device's effectiveness, 5-3 against its safety (with one abstention) and said the risks outweigh the benefits by a vote of 8-0 (with one abstention).
The FDA's Janet Woodcock may be Sarepta CEO Chris Garabedian's favorite person today.
The FDA's General and Plastic Surgery Advisory Panel will meet Aug. 1 to consider the PMA application of Cohera Medical's TissuGlu surgical adhesive in large-flap surgical procedures such as abdominoplasty (tummy tuck surgery).
Given the publicity that has come with FDA bans on a growing list of Indian facilities, even a report of an FDA shortfall at a plant can have consequences these days. That is where India's Cadila Healthcare found itself Thursday when news that it received an FDA Form 483 took a big bite out of its market cap.