Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

FDA grants Celgene's Revlimid new use as it moves toward $10B in sales

Celgene's powerhouse cancer drug Revlimid generated nearly $5 billion for the company last year and has now gotten yet another FDA nod which analysts believe will help it double that amount within 5 years.

FDA panel to consider PMA application of spinal implant

The FDA's orthopedic advisory panel will investigate the agency's concerns about fractures to the back of the spine resulting from the investigational VertiFlex Superion Interspinous Spacer as it deliberates on Feb. 20 whether to recommend the device's PMA application for FDA approval.

NICE, drugmakers reject analysis that price watchdog is too generous

Drugmakers are often at odds with the National Institute for Health and Care Excellence (NICE) in England, saying it is stingy in what it will approve as payments for their best new treatments. But the industry and the gatekeeper have pulled together in defending against a study that says NICE is paying drugmakers too much for their best new treatments.

Roche and Exelixis roll toward FDA approval with a melanoma cocktail

Roche and Exelixis are one step closer to FDA approval for their skin cancer-treating combination treatment, as the agency has accepted their application and promised a speedy review.