Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA official, panelists challenge Avandia safety trial

Dr. Thomas Marciniak, medical team leader of FDA's Division of Cardiovascular and Renal Products, made some expensive promises Wednesday morning before a panel of outside experts tasked with advising the FDA on whether to lift current restrictions on GlaxoSmithKline's diabetes drug Avandia.

Intuitive faces investor lawsuit as da Vinci claims await

Intuitive Surgical may have won its first liability lawsuit over the da Vinci surgical system, but the company now has to contend with ire from shareholders who claim it made misleading statements to inflate its stock price.

Impax cuts 110 jobs tied to problems at plant

Manufacturing problems at Impax Laboratories'  California plant first cost the company a drug approval, then a $186 million partnership with GlaxoSmithKline. Now, it is costing 110 workers their jobs.

FDA issues warning letter for Novartis Ebewe plant

Any drug manufacturer that fails to take instructions from FDA is inviting trouble, and that is what Novartis got by releasing products from a Sandoz Ebewe plant after the agency said they had been manufactured using unapproved inspection procedures.

Abbott posts positive MitraClip results as FDA looms

After squeaking by an FDA panel in March, Abbott Laboratories' is touting new study results for its MitraClip device, finding it safe and effective for the treatment of mitral regurgitation, a valve disorder that hampers heart function.

Cook wins 510(k) status for next-gen biliary stent

Cook Medical's new gastrointestinal tract stent won a pivotal 510(k) clearance, allowing the company to build on a European regulatory nod it won a year ago.

FDA officials divided on Avandia safety as panel meeting looms

Ahead of this week's FDA advisory panel meeting, staff reviewers backed a readjudication of the controversial RECORD trial, which found that the GlaxoSmithKline diabetes drug Avandia does not increase cardiovascular death risks.

FDA clamps clinical hold on Pluristem PhII stem cell trial

One of the patients enrolled in a mid-stage study for an experimental stem cell therapy from Pluristem Therapeutics suffered a severe allergic reaction, sending him to the hospital and prompting FDA officials to clamp a clinical hold on the study.

Medtronic wins FDA nod, CE mark for angioplasty balloon

Medtronic is expanding its presence in peripheral artery disease, winning FDA clearance and a CE mark for the Pacific Plus balloon catheter, a next-generation vascular treatment.

R&D: Are true drug breakthroughs a thing of the past?

The agency is offering developers essentially an open door at the FDA to any program that qualifies, urging on R&D teams with quick responses and help adapting trials and hurrying the review process with an aim to getting more "transformative" drugs to the market faster.