Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

FDA sets new limits on use of immediate-release opioids

After years of criticism that they were not doing enough to fight the growing abuse of opioids, federal authorities are piling on new guidelines and warnings for the powerful painkillers. The FDA is the latest with box warnings about what it called the serious risks of misuse, abuse, addiction, overdose and death.

NICE gives initial thumbs-down to Vertex's CF combo med Orkambi, citing costs

Vertex Pharmaceuticals has been charging ahead with its cystic fibrosis med Orkambi, but now the company is facing a roadblock in the U.K. The country's National Institute for Health and Care Excellence (NICE) recommended against funding the drug, saying that it did not demonstrate enough benefits to patients to justify its high cost.

China in overdrive on illegal vaccine sales probe

Chinese leadership moved into high-gear to round up dozens of suspects linked to the illegal sale of vaccines in Shandong province, drawing in comment from the State Council and noting World Health Organization interest in the incident on the China FDA website.

India's Commerce Ministry shoots down CL ban claim

India's Commerce Ministry has shot down claims by the U.S.-India Business Council that compulsory licenses for drugs are a thing of the past.

Eli Lilly scores a big win with FDA OK for blockbuster psoriasis contender ixekizumab

Eli Lilly won FDA approval for ixekizumab, a blockbuster hopeful that will compete against a new wave of rival therapies for psoriasis. The drug will be sold as Taltz.