Topic:

Regulatory

Latest Headlines

Latest Headlines

Prosecutors heap more woe on OBI Pharma as 'insider trader' investigation deepens

The bad news just keeps coming for Taiwan's biotech firm OBI Pharma as the country's prosecutor has released new information alleging that the daughter of the head of Taiwan's lead science research agency did in fact sell some of her company stock just three months before it announced the failed trial of its lead cancer drug.

A second Indian vaccine maker under WHO scrutiny raises concern

India's second vaccine maker to get bad marks and stern words in a World Health Organization (WHO) notice this month has come at a bad time not only for offender Ahmedabad-based Cadila Healthcare, but also for a prequalification system essential to global programs.

China FDA sets out GCP guide for medical devices to take effect in June

China FDA has unveiled guidelines on medical device clinical trial supervision and management that will take effect in June, marking the latest effort in the field to ensure quality and safety standards for multinational and domestic products.

UPDATED: China FDA vows to fix vaccine supply 'gaps' in remarks at Boao Forum

China FDA repeated that it will root out any "gaps" in the regulation of vaccines exposed in a case of illegal sales of products in Shandong province, using a public forum to vow a tough response.

Philips shells out $35M to settle sleep apnea mask kickback charges with DOJ

Respironics, the sleep and respiratory business of Royal Philips, has settled with the U.S. Department of Justice for $34.8 million on kickback charges for its sleep apnea masks. It will pay $34.1 million to the federal government and about $660,000 to state governments based on their Medicaid program participation.

China, in typical fashion, arrests dozens as drug oversight draws attention

In a typical response to publicity that its pharma supply chain has been breached, China has rounded up dozens of suspects as it investigates an operation said to have illegally sold vaccines that may have not been safely stored or shipped.

Cadila faces new regulatory problems as WHO piles on the pain

It has been a tough few months for India's Cadila Healthcare. After having two plants slapped by the FDA with a warning letter, the Indian drugmaker has now had a vaccines facility cuffed in a notice of concern by the World Health Organization (WHO) after it was found faking data about contamination issues at the facility.

Novartis settlement with U.S. SEC on China bribes one in a string

Swiss-based Novartis has paid the U.S. SEC for $25 million to settle civil charges it bribed medical personnel in China to boost drug sales during the decade from 2003 to 2013, Reuters reports.

Taiwan's OBI trial results dispute snares top science research executive

An effort to reassure investors after Taipei-based OBI Pharma posted disappointing clinical trial results on breast cancer candidate OBI-822/82 has apparently backfired for the head of Taiwan's lead science research agency after reports his daughter is a top shareholder.

Lilly's new psoriasis med Taltz sets up head-to-head with Novartis' Cosentyx

Move over, Cosentyx--there's a new next-gen psoriasis med in town. On Tuesday, the FDA approved Eli Lilly's Taltz, the second IL-17A med to win its favor behind Novartis' contender.