Topic:

Regulatory

Latest Headlines

Latest Headlines

India's Cipla gets first FDA approval of oral pellet to treat HIV/AIDS in infants

India's Cipla recently got FDA approval for a pediatric formulation of the combo drug lopinavir/ritonavir to treat HIV/AIDS in the developing world, but not in the U.S., where market exclusivity rules apply.

FDA asks experts to weigh in on PCSK9 drugs' market reach for Amgen, Regeneron/Sanofi

The blockbuster race between Amgen and a team from Regeneron and Sanofi for cutting-edge PCSK9 drugs comes down to this: back-to-back panel reviews to discuss the designated endpoint for cutting LDL as a surrogate for cardio benefits as well as the potential negative effect these new drugs could have on the massive demand for statins.

Pfizer apologizes to U.K. docs as Lyrica protection campaign hits snag

Pfizer's bid to protect its pain drug Lyrica (pregabalin), which has lost some patent protection in the U.K., has had some unintended side effects.

Health Diagnostic Laboratory rails against physician kickback claims

Health Diagnostic Laboratory is pushing back at allegations that the company violated antikickback law by paying doctors for ordering blood tests, a couple of months after the lab giant said it would shell out $47 million to settle claims filed by the Justice Department over payments to physicians and Medicare billing.

China's 3SBio returns to market and pulls in $710.7M in HK IPO

Mainland China biotech 3SBio raised $710.7 million through an initial public offering on the Hong Kong Stock Exchange, reaching the high end of expectations two years after delisting from the Nasdaq and going private and highlighting a series of other recent biotech-related capital moves in Greater China.

Complaints trickle in about higher drug prices in China after cap removal

A Chinese press report cited a surge in the price of digoxin tablets, a purified cardiac glycoside, in Shaanxi province as evidence that a shift in national policy has quickly reached the grassroots.

India's Sun says slow and steady on Ranbaxy plants, FDA on Wockhardt at odds with management

Manufacturing woes in India continue in the spotlight, though Sun Pharmaceuticals says it will focus on one plant at a time to restore the fortunes of four Ranbaxy manufacturing units banned by the U.S. FDA.

GSK, Sanofi hauled up by India's competition watchdog on vaccine tenders

India's competition watchdog said that government vaccine procurement rules favored multinational drugmakers Sanofi and GlaxoSmithKline and the companies colluded in pricing, according to the Economic Times, charges that both companies denied in response to queries from FiercePharmaAsia.

NICE sings a different tune for Bayer's prostate cancer drug Xofigo

Bayer has had a tough time winning approval from U.K. cost-effectiveness gatekeepers for its prostate cancer therapy Xofigo. Now, the company is celebrating a bright point for Xofigo as NICE changed its tune and backed the drug for certain patients.

FDA says Sanofi and Regeneron's cardio contender looks approvable. But for whom?

A potential blockbuster from Sanofi and Regeneron has proven its ability to slash rates of cholesterol, the FDA said, but questions remain on just how widely the treatment should be used.