Topic:

Regulatory

Latest Headlines

Latest Headlines

Metal-based bioresorbable vascular closure device obtains CE mark

Transluminal Technologies has announced it has received a CE mark for the bioresorbable Velox CD Vascular Closure Device for hemostatis, or stopping bleeding, in the thigh's femoral arterty following procedures involving needle puncture.

FDA names 107 devices it will exempt under new guidelines

The FDA has released a list of 107 medical devices it will exempt from its 510(k) premarket notification regulations as part of the agency's efforts to streamline its approval process for products similar to those that have already undergone testing and trials.

FDA piles misery onto Impax with 2nd Form 483 in a week

Impax Laboratories has gone 0 for 2 in an FDA plant inspection double header. After acknowledging last week that the FDA had issues with its plant in Taiwan, the California-based Impax said the FDA has now issued a Form 483 for a just-completed inspection at its Hayward, CA, facility.

Cohera's surgical adhesive narrowly wins FDA panel support

Cohera Medical's TissuGlu surgical adhesive took another step towards securing PMA approval from the FDA, following the narrow recommendation of the agency's General and Plastic Surgery Advisory on Aug. 1. The panel voted unanimously that the device is safe, 6-5 that it is effective and 6-4 that it has a favorable risk-benefit profile.

Amgen preps for swift FDA review as Kyprolis/Revlimid combo stymies myeloma

Amgen put out the word Monday morning that Kyprolis--provided in a combo package with Celgene's Revlimid--beat out Revlimid alone in a head-to-head Phase III study for multiple myeloma, hitting the primary endpoint and offering the Big Biotech a shot at expanding its franchise for the drug at a critical moment in the company's history.

Senate bill would set NIH budget floor, raise funding over 7 years

A decade of flat funding compounded by last year's federal sequester cuts has put U.S. biomedical research in a pinch in recent years, but under a new bill the National Institutes of Health would be spared the budget ax.

Sanofi dengue vaccine filings could come as soon as next year's Q1, CEO says

Sanofi's in line to rack up blockbuster sales after hitting a wide-open market with its dengue vaccine, analysts predict. And company CEO Chris Viehbacher thinks those sales could start rolling in before next year is out.

Lilly, Boehringer win FDA approval for once-rejected diabetes drug

After a manufacturing issue scuttled their first attempt, Eli Lilly and Boehringer Ingelheim have won the FDA's blessing to market their new diabetes drug, a late entrant into a crowded space.

FDA comes around on Boehringer, Lilly's diabetes med Jardiance

The FDA is changing its tune on Jardiance, a Boehringer Ingelheim diabetes med it hasn't been so keen on in the past. After rejecting the drug in the face of a manufacturing issue, the agency Friday gave it approval to treat Type 2 diabetes.

Can Boehringer carve out space in a crowded COPD market with new approval?

The COPD market has its fair share of contenders, but that's not stopping Boehringer Ingelheim from joining the party. The German drugmaker has nabbed FDA approval for its own entrant, which will go up against the likes of Glaxo's aging giant Advair in a market-share showdown. But despite the competition, BI is hoping it can still find its corner.