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FDA announced July 31 that it intends to issue a draft guidance soon that would require moderate and high-risk diagnostics to obtain 510(k) or PMA approval, regardless of their place of origin, putting an end to a battle to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.
Sanofi and Regeneron just stole a march on Amgen in the race to get their PCSK9 cardio drug through the FDA and onto the market. The two companies revealed Wednesday evening that they had picked up a priority review voucher BioMarin had won for a recent rare disease drug approval, paying $67.5 million for the regulatory shortcut. They'll split the cost and share in the benefit, shaving four months off the regulatory review time for alirocumab.
Ranbaxy, India's largest generic drugmaker, reported a quarterly loss as plant bans sucked out sales and it made a $40 million provision for ongoing legal problems with U.S. authorities.
Medical device manufacturers could soon be looking at additional expenses following proposed changes to the Physician Payment Sunshine Act.
On the heels of FDA's rejection of the AcelRx New Drug Application for sublingually delivered postoperative pain killer Zalviso, CEO Richard King expounded on the "optical system errors" of the opioid drug's handheld, preprogrammed delivery device during a July 28 conference call with investors.