Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATE: Gilead hauled up over ADR reporting in Japan

Japan's Ministry of Health, Labor and Welfare (MHLW) scolded Gilead Sciences Inc. for its failure to report overseas adverse drug reaction (ADR) cases involving three drugs within the required timeframe.

American Chamber survey finds companies less sanguine on China prospects

American businesses, including members of the pharmaceutical industry, appear to be less sanguine about their prospects of doing business or expanding it in China.

23andMe scores FDA OK to market genetic carrier test direct to consumers

23andMe nabbed FDA clearance to market its genetic carrier test directly to consumers, a big win for the company as it continues to get back in the agency's good graces and expand the reach for its genetic tests.

Ex-Merck analyst pleads guilty to insider trading

Former Merck analyst Zachary Zwerko pleaded guilty to federal insider-trading charges on Thursday for passing merger tips to a business school chum. The tips allowed the New York Mellon trader to make $700,000 in profits, Bloomberg reports.

23andMe nabs FDA marketing clearance for direct-to-consumer genetic carrier test

23andMe scored FDA clearance to market its direct-to-consumer genetic carrier test for Bloom syndrome, a crucial win for the company as it continues to make good with the agency and expand the reach for its genetic tests.

Medtronic, Bard secure supplemental Medicare reimbursement for their new drug-coated balloons

Medtronic and C.R. Bard announced that they have obtained supplemental Medicare reimbursement for peripheral artery disease outpatients who are treated using their recently approved drug-coated balloons.

Drug tender in China's Hunan province has industry up in arms

A cross-section of pharmaceutical industry players in China has objected to the steep price cuts of as much as 50% in a late January tender process in China's Hunan province.

India's CDSCO moves to expand access to Tamiflu as H1N1 flu spreads

India's CDSCO has requested local regulators to update a 2009 list of the names of pharmacies that are licensed to sell, stock or distribute oseltamavir phosphate (Tamiflu) in India in an effort to facilitate access to medications to combat swine flu (H1N1).

India Finance Ministry kicks the can on Aurobindo, Glenmark foreign investment

India's Finance Ministry kicked the can down the road for another agency to determine whether $67 million worth of foreign direct investment should be opened for Aurobindo Pharma and Glenmark Pharmaceuticals.

FDA warns of device design amid UCLA superbug outbreak

Amid a drug-resistant "superbug" outbreak at the UCLA Health System in California, the FDA is warning doctors and hospitals that endoscope devices' complex design may hinder proper cleaning, contributing to the spread of deadly bacteria.