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