Topic:

Regulatory

Latest Headlines

Latest Headlines

Med techs Avinger, HTG file for IPOs

Catheter-based peripheral artery disease treatment company Avinger filed with the SEC to raise up to $69 million, while molecular diagnostics player HTG Molecular Diagnostics filed to raise up to $60 million. In addition, orthopedic regenerative medicine player CollPlant is reportedly seeking a listing on a U.S. market; it is already listed publicly in Israel.

China's Novacyl Wuxi gets FDA warning letter

The FDA has issued a warning letter to a Chinese plant that makes active pharmaceutical ingredients for having suspect testing data after finding a failed test result in the trash and discovering the computer record of it had been overwritten. The letter comes as the agency is working to get more inspectors into the country, which has become the go-to producer of cheap APIs for the global market.

Merck poised for early Keytruda launch in lung cancer, analyst says

New Year, new expectations for Merck & Co. Bernstein Research analyst Tim Anderson predicts an earlier-than-expected expansion for Keytruda, the company's newly approved cancer immunotherapy. And that would mean hundreds of millions in additional 2015 sales, plus an accelerated boost to revenue and earnings for years to come.

FDA deems Halyard's recalled KimVent endotracheal tubes potentially deadly

The FDA slapped Halyard Health's KimVent Microcuff endotracheal tubes with its most severe, Class I recall label, meaning "there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the agency.

Aethlon Medical snags FDA approval for clinical trial of Ebola device

As med tech companies home in on innovative ways to quell the growing Ebola outbreak, Aethlon Medical snagged FDA approval for a clinical trial of its biofiltration device in patients with the virus.

Covance could face fines over animal deaths

A malfunctioning thermostat led to the deaths of 13 research primates at a Covance facility, according to authorities, and the CRO could be in line for federal punishment.

Vertex gets 500-patient boost with FDA's newest Kalydeco nod

Vertex will start the new year with a group of new eligible patients for cystic fibrosis drug Kalydeco, thanks to a Monday green light from the FDA.

FDA outlines industry-focused ambitions as Mini-Sentinel graduates

Having grown to include data from 178 million patients during its 5-year history, the FDA's active safety surveillance system Mini-Sentinel has now graduated into a fully fledged program. And the FDA is already planning future iterations of the technology, including a possible industry-focused offshoot to support drug development and quality improvement.

Biopharma posts a chart-topping 41 new drug approvals in 2014

A burst of new drug approvals at the FDA just before Christmas pushed the total to 41 for 2014, the fastest pace in the past 18 years and a fresh sign that at least a few of the lead players have...

FDA trusts vets to curb antibiotic use, but are ties to drug companies too tight?

Under a new FDA policy that goes into effect this year that's meant to halt the rampage of antibiotic-resistant bacteria that endanger human health, veterinarians will be the gatekeepers who decide whether to prescribe antibiotics to farm animals.