Topic:

Regulatory

Latest Headlines

Latest Headlines

North Carolina compounder is closed and its products are recalled

For more than two years, the FDA has been very clear about the standards its expects U.S. drug compounders to maintain and the very harsh penalties that can await those who don't comply. But some still haven't heeded the message, and last week North Carolina authorities closed one and the FDA warned providers not to use any of its products.

Amgen CEO Bradway collects a $14M pay package on record-breaking revenue

In a year when several of his peers won big payoffs for one extraordinary reason or another, Amgen CEO Robert Bradway earned just about as much as he had the previous year, give or take a few hundred thousand. Small comfort--though some comfort, perhaps--to the thousands of employees facing job cuts as Amgen prepares for biosimilar competition to its top-selling meds.

AstraZeneca gets FDA nod for alternative administration of oral heart med

AstraZeneca's Brilinta can now be crushed and mixed with water or delivered through the nose via a tube, the FDA said, in a move designed to help patients who are unable to swallow the 90-mg tablets whole.

Cytori Therapeutics says licensee Lorem gets CFDA nod for Celution System

Nasdaq-listed Cytori Therapeutics said its exclusive licensee, Lorem Vascular, has been granted regulatory clearance for the Cytori Celution System by the China Food and Drug Administration, triggering a "substantial 2015 product purchase order for Cytori from Lorem Vascular."

Under pressure, Zoetis pulls arsenic-based poultry drug from market

The FDA announced Wednesday that Zoetis has agreed to withdraw the arsenic-based drug Histostat (nitarsone) from the market by this fall. The move follows years of pressure from food safety groups concerned that the drug--used to prevent blackhead disease in poultry--could endanger human health.

Physician heal thyself, New England Journal of Medicine paper says of China healthcare

China's plan to revamp its healthcare system to get costs under control rests in large part on creating a professional culture among doctors and support staff in prescribing drugs and ordering tests, according to an article published last week in the New England Journal of Medicine.

Japan's MHLW seeks candidates for fast-track innovative approval push

Japan's Ministry of Health, Labor and Welfare wants companies to offer innovative drug candidates for its accelerated approval "sakigake" designation system to be launched this fiscal year with a focus on shortened review times.

Samsung Pharma to launch GemVax cancer vaccine in South Korea

Samsung Pharmaceutical will manufacture and sell GemVax & KAEL Co. pancreatic cancer vaccine Riavax in South Korea.

In a quiet move, India ends free drugs, diagnostics to public health units

No fanfare, no press releases for this government action: India has decided to drop its three-year-old practice of providing free drugs and diagnostics in the nation's public health facilities.

India defends GVK Biosciences in falsified trial data allegations

India drug authorities are mounting a full-court press against their European counterparts in defense of GVK Biosciences, a contract research organization under fire for alleged manipulation of trial data. The pushback includes a threat to sue and another to take the matter to the World Trade Organization.