Latest Headlines

Latest Headlines

FDA calls for beefed-up oversight of lab-developed tests

The FDA is calling for more oversight of lab-developed tests (LDTs) in the wake of a congressional hearing about the agency's ability to regulate the products, pointing to a new internal report that says certain LDTs "may have caused or have caused" harm to patients by producing incorrect results.

Baxalta Singapore plant gets FDA OK to produce Advate hemophilia product

The hemophilia A treatment Advate is the cornerstone to the future of Baxalta, the company that was created when Baxter International spun off its drug operations in July. Now the newbie will be able to produce more of the product at a plant in Singapore it opened just last year.

FDA approves, Medtronic launches the first remote monitoring pacemaker app

Medtronic has launched the first app-based remote monitoring for implantable pacemakers. Remote monitoring of pacemakers has been the standard of care, but this next-gen version goes beyond a dedicated device to do so.

Valeant adds recall to long list of problems

Add to Valeant Pharmaceuticals' growing list of problems a manufacturing mess-up that is leading to a recall of a cholesterol fighter.

U.S. lawmakers step up drug-pricing probes, add Valeant pharmacy to their target list

The U.S. House Committee on Oversight & Government Reform, already casting an uncomfortable spotlight on pharma pricing, set up a task force this month and promised "meaningful action." Now the committee is plotting its next course of action, planning a hearing in 2016 to investigate companies' pricing policies. And activist Rep. Elijah Cummings has added Valeant's specialty pharmacy Philidor to his own investigations.

Indian officials say EU willing to split trade talks from drug spat

Indian commerce officials say the European Union is showing a willingness to restart trade talks and separate those discussions from a ban on 700 drugs tested in India that imperils exports worth billions of dollars, according to a report by India's  Economic Times. 

J&J nabs an early OK for 'breakthrough' multiple myeloma blockbuster contender Darzalex

Johnson & Johnson scored an early FDA approval for its "breakthrough" blockbuster contender daratumumab, earning a swift OK as a new treatment for multiple myeloma four months ahead of the PDUFA date. The drug will be marketed as Darzalex.

Baxalta wins FDA OK for a long-acting Advate, padding its hemophilia biz

The FDA signed off on Baxalta's twice-weekly upgrade on the top-selling Advate, adding another hemophilia A treatment to the company's portfolio as it faces buyout pressure from Shire.

HK-based Chi-Med takes another regulatory step to Nasdaq listing

Hong Kong-based Hutchison China MediTech, or Chi-Med, has moved another notch up the U.S. listing regulatory process, filing an F-1 form with the U.S. SEC and providing a detailed financial snapshot, the company said in a press release.

India looks to push development of biotech startups

A senior Indian official says plans are underway to ramp up the biotechnology sector and add 1,500 startups in the next two to three years, according to a report in the Economic Times.