Topic:

Regulatory

Latest Headlines

Latest Headlines

Bristol-Myers' next-gen HIV med gets FDA 'breakthrough' designation

Bristol-Myers Squibb nabbed a "breakthrough" tag from the FDA for its next-gen HIV therapy aimed at patients who become resistant to the drugs now in use.

'Cures' bill, designed to speed drug approvals, could be too much of a good thing, dissenters say

The FDA has made strides in shortening review times and accelerating the path for breakthrough treatments, but a new bill designed to break down even more regulatory barriers has attracted a chorus of critics worried that it could go too far at the expense of patients.

UPDATED: Amgen beats Regeneron, Sanofi to world's first big PCSK9 drug OK

Amgen may be running a beat or two behind Regeneron and Sanofi in search of the first FDA approval for a PCSK9 drug, but the Big Biotech scooped up the very first approval in Europe today for Repatha (evolocumab), giving the company boasting rights as first mover in what is widely seen as a new blockbuster market in the making.

Medidata's de Vries on disruption in Asia drug research with Japan a focus

Medidata President Glen de Vries said he is a firm believer in putting talent in place on the ground in Asia. The company began with Japan in the region and that existing footprint, he said, has opened up opportunities as technology and biologics combine to disrupt drug discovery in the country.

India's Sun Pharma sees multiyear earnings hit as it fixes plants, integrates Ranbaxy

Sun Pharmaceutical Industries founder and managing director Dilip Shanghvi said earlier this year his first priority after the purchase of Ranbaxy Laboratories was to solve regulatory and integration issues. This week, he presented the bill to investors.

FDA approves Abbott 3-D Lasik system to improve accuracy, expand indication

The U.S. Food and Drug Administration has approved the iDesign Advanced WaveScan Studio System from Abbott Laboratories. The company has already launched the system, which is based on a 3-D map of the eye that's expected to improve the accuracy of Lasik procedures.

ASLAN and Singapore's NCCS plan studies on Asia-prevalent cancers

Singapore-based ASLAN Pharmaceuticals has signed an understanding with the National Cancer Centre of Singapore (NCCS) to study novel combination therapies to treat gastric cancer, hepatocellular carcinoma and cholangiocarcinoma, in its second move in this month to explore wider avenues for its existing clinical trial candidates.

FDA turns to Google for help spotting adverse events

The FDA has approached Google for help identifying adverse drug events in search data. The regulator hooked up with Google to access the insights of Evgeniy Gabrilovich, an engineer at the tech behemoth who has published papers on the subject of mining search queries for adverse event reports.

AdvaMed welcomes legislation to separate India's device and drug oversight

Legislation pending in India's parliament that would draw a sharp line between medical devices and drugs is welcome, the India arm of a key industry body for devices told the  Economic Times,  as passage could come in the next session of parliament due to start this week.

Beijing eyes urban 'super hospitals' in healthcare reform battle

China healthcare policymakers are fighting a losing battle to curb the growth of public urban "superhospitals" that now see expansion as more important than ever to survival in the face of a move in May to scrap a 15% markup on drug prescriptions, Reuters reports.