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