Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

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.

Aerin Medical raises $16.7M to back radiofrequency device to remodel nasal tissue

There aren't a lot of attractive options to treat nasal breathing disorders. Most are limited to unwieldy devices to aid breathing or surgical alteration of the nasal anatomy. Startup Aerin Medical hopes to offer a novel noninvasive approach--the use of nonablative radiofrequency energy to target and remodel nasal tissues to treat breathing orders caused by anatomical obstruction and mucosal dysfunction.

Cancer care triage in Asia shows treatment options gap

A hard look at cancer treatment options in Asia highlighted the gap in treatment pathways for innovative therapies in developing economies with much of the focus now on either screening or palliative care.

BioPharmaSpec plots Asian expansion with a focus on biosimilars

BioPharmaSpec is expanding its business into the potentially lucrative Asian market as new business development teams begin work in India and the Asia-Pacific region this month.

UPDATED: China FDA on the hunt for illegally sold vaccines in Shandong

A mother-and-daughter team allegedly behind a massive illegal sale of vaccines in Shandong province are under arrest as China FDA moves to track down the potentially harmful supplies by calling for immediate help from manufacturers and distributors.