Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA to review modified-release version of Pfizer's Xeljanz for rheumatoid arthritis

Pfizer just announced that the FDA agreed to review a daily, 11-milligram modified-release tablet of its rheumatoid arthritis drug Xeljanz for patients who don't respond adequately to methotrexate (marketed as Rheumatrex and Trexall).

BG Medicine gets FDA blessing for automated chronic heart failure test

BG Medicine got an FDA nod for an automated version of its test for chronic heart failure, a win for the company as it charges ahead with development after laying out some cost-cutting measures last fall.

Theranos nabs FDA clearance for finger-stick herpes test

Theranos moved a step closer to its vision of providing cheap and rapid point-of-care diagnoses based on a few drops of blood thanks to its first FDA clearance. The agency said the Theranos System can be used to detect herpes simplex virus 1.

Alibaba Health plans wider online sales push in China as competition heats up

Alibaba Group Holdings aims for a controlling stake in HK-listed Alibaba Health Information Technology as it seeks to grow in a still-fragmented market in China for online drug sales that increasingly looks like a tough nut to crack as competition grows and regulatory approvals drag, the South China Morning Post reports.

Orthopedic implant makers fight India price law scope, but NPPA says the law wins

Price checks by India's National Pharmaceutical Pricing Authority on certain orthopedic implants have once again raised hackles by companies concerned they are being swept up in a law that was not meant for their industry, Business Standard reports.

Japan's Otsuka eyes MDR-TB drug nod in Indonesia in team with Nipro diagnostic effort

Otsuka Pharmaceutical has applied to sell multidrug-resistant tuberculosis drug Delamanid in Indonesia and join hands with fellow Japanese firm Nipro to ramp up diagnostic efforts, the Nikkei Asian Review reports.

Takeda's Hasegawa out as JPMA VP after firm called to task on Blopress

Takeda Pharmaceutical Chairman Yasuchika Hasegawa was removed as vice president by the Japan Pharmaceutical Manufacturers Association, according to an updated leadership list that was confirmed by a company spokesman.

Congressman pushes to unshackle pharma on social media

A congressman is taking aim at perceived flaws in FDA's long-awaited, much-discussed guidance on the use of Twitter.

USDA amends rules to allow vets to make custom vaccines in their offices

The U.S. Department of Agriculture has amended its rules to allow veterinarians to make vaccines in their offices for individual clients, as long as compounds aren't contracted out to unlicensed manufacturers.

Stormy Australia hearings on transfer pricing by drug firms invoke Sergeant Schultz

Multinational drug firms in Australia faced a string of barbs in hearings held by a Senate panel into transfer pricing that included a reference to a fictitious German World War II prison camp guard.