Topic:

Regulatory

Latest Headlines

Latest Headlines

Venrock unveils a $450M new fund with eyes on biotech

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 scores 250 new Kalydeco patients with EMA approval

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.

Industry, Dems and GOP clash on looming diagnostics regulations

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. 

FDA panel green-lights Baxter and Halozyme's drug on a second pass

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.

Boehringer plays catch-up in COPD with its latest FDA approval

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.

UPDATED: FDA announces intention to comprehensively regulate lab-developed tests

FDA announced July 31 that it intends to issue a draft guidance soon that would require moderate and high-risk diagnostics to obtain 510(k) or PMA approval, regardless of their place of origin, putting an end to a battle to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.

Ablatherm ultrasound prostate cancer treatment rebuffed by FDA panel

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).

Muscular dystrophy biotechs buoyed by FDA's encouragement on accelerated OKs

The FDA's Janet Woodcock may be Sarepta CEO Chris Garabedian's favorite person today.

FDA advisory panel to consider PMA of TissuGlu surgical adhesive

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).

Report of Form 483 for Cadila wreaks havoc with its shares

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.