Topic:

Regulatory

Latest Headlines

Latest Headlines

Sanofi sees Shantha Biotech's Shan5 back in 2014

When Sanofi bought an 80% stake in Indian vaccinemaker Shantha Biotech in 2009, the talk was of the deal accelerating growth in emerging markets.Things played out a little differently though.

J&J gains pivotal PMA for computer-aided surgical sedation device

Johnson & Johnson achieved a pivotal FDA PMA approval for what is being billed as the first computer-assisted sedation system, now available for endoscopy procedures.

J&J's propofol administration device finally wins FDA nod

Johnson & Johnson won FDA approval for its Sedasys device to administer the sedative propofol.

Johnson & Johnson, Pfizer target painkiller revivals as FDA warms to abuse deterrents

The FDA has fueled a pharmaceutical arms race in the painkiller market with the agency's decision last month to bar the sale and production of generic OxyContin, which has become one of the most widely abused opioids among Americans.

Indian watchdogs pull J&J plant's license on baby-powder sterilization issue

South Korean regulators have forced Johnson & Johnson to halt production at an over-the-counter drug plant, and Indian watchdogs are doing the same at a consumer healthcare facility in their country.

Medtronic wins FDA nods for next-gen cardiac devices

Medtronic is padding its fleet of U.S.-approved cardiac devices, winning the FDA's blessing to market new Viva and Evera implants.

AbbVie gains inside 'breakthrough' track at FDA for hot hep C combo

The company says that the FDA has picked its antiviral combo--with and without ribavirin-- as a new breakthrough therapy worthy of a swift review and perhaps a shortened clinical trial process ahead of a regulatory decision.

Novartis promises to test the full value of FDA's 'breakthrough' status

Ever since the FDA started to anoint a short list of drug candidates as "breakthrough" therapies deserving of swift regulatory reviews, the industry has been trying to puzzle out one important question: What does it mean?

Medtronic lops off 230 spinal jobs, endures FDA blemish

Medtronic is following through on its long-held plans to slash jobs in its spinal business, cutting 230 positions as revenues falter. Meanwhile, the FDA slapped its most serious recall label over a potentially deadly flaw with the device giant's deep-brain stimulators.

Biotech financier Blech gets jail time in 'No mercy' sentence

A federal judge wants biotech investor David Blech behind bars. Blech pleaded guilty last year to trading schemes involving stocks in the biotech companies Pluristem Therapeutics ($PSTI) and Intellect Neurosciences ($ILNS), and yesterday he and his attorney asked U.S. District Judge Colleen McMahon in Manhattan for leniency in his sentencing.