Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA adds PML death scenario to Tecfidera label

When Biogen Idec reported last month that a patient taking its hot multiple sclerosis pill Tecfidera had developed a rare brain infection and died, the drugmaker said it believed the safety profile of the drug remained solid. Perhaps so, but the FDA has decided the death was important enough to add a description of it on Tecfidera labels.

With Duaklir nod in EU, AstraZeneca scores first new drug from Almirall buyout

With the EU approval of COPD med Duaklir, AstraZeneca is getting exactly what it wanted when it sealed a deal for Almirall's respiratory portfolio earlier this month. The only problem? Calling the market crowded is an understatement.

Covidien reveals that it is under federal subpoena

In its annual 10-K filing with the SEC, Covidien quietly noted that it is under a federal subpoena related to some of its  peripheral vascular products.

AstraZeneca's Almirall buy yields its first new drug--and now, AZ has to sell it

With the EU approval of COPD med Duaklir, AstraZeneca is getting exactly what it wanted when it sealed a deal for Almirall's respiratory portfolio earlier this month. The only problem? Calling the market crowded is an understatement.

Congress considering bill to limit FDA regulation of EHRs, clinical decision support software

A bill circulating the halls of Congress would limit the FDA's oversight of electronic health records and clinical decision support software, but may not have much practical effect since the agency limited its role in the regulation of software in a June draft guidance.

AstraZeneca, Ranbaxy unable to kill Nexium pay-for-delay lawsuit

AstraZeneca and Ranbaxy Laboratories have been unable to wiggle out of a pay-for-delay case that said they colluded to keep generics of AstraZeneca's blockbuster heart medicine off the market until its patent expired in May 2014. The drug is still not on the market but at this point it is not because of backroom deals but because of FDA oversight and Ranbaxy's drug testing mess ups.

J&J hopes third time is the charm for antitumor agent Yondelis

Five years after the FDA formally rejected J&J's Yondelis (trabectedin) for ovarian cancer, and three years after an aborted effort to get it back on track, the pharma giant has finally made its way back to the agency for another try at an approval--this time as a treatment for soft tissue sarcoma.

UPDATED: Covidien gets 510(k) for peripheral balloon catheter aimed at hemodialysis patients

Covidien today announced FDA 510(k) clearance for its Fortrex percutaneous transluminal angioplasty balloon catheter, designed to maintain arteriovenous access in hemodialysis patients suffering from chronic kidney disease or end-stage renal failure.

FDA cracks down on power morcellator devices in updated safety guidance

Amid growing backlash over tools used in minimally invasive gynecological procedures, the FDA is cracking down on the devices in updated safety guidance.

U.K. gatekeepers toughest on cancer meds--and getting tougher all the time

The U.K.'s cost gatekeeper is notoriously strict when it comes to approving drugs, shooting down meds based on strict cost-effectiveness standards or saddling them with restrictions. But cancer drugs could face the toughest road ahead, as a new report shows that the National Institute of Health and Care Excellence is less likely to green-light the meds compared to other classes of drugs.