Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATED: Vertex wins a crucial FDA nod for its cystic fibrosis combo, prices at $259,000

Vertex Pharmaceuticals won the FDA's blessing to market a new combination therapy for cystic fibrosis, clearing the way for a drug key to the company's future as it moves away from antiviral treatments.

FDA exempts 120 devices from 510(k) clearance requirements

The FDA said it will not enforce 510(k) clearance regulations on 120 low-risk classes of devices, making life easier for the device industry.

FDA approves a second placement confirmation test for Bayer's controversial Essure birth control device

It may be too little too late. But now the FDA has signed off on the use of transvaginal ultrasound as a means of ensuring the proper placement of the Essure permanent birth control device within three months of its insertion.

Gilead takes a $125M FDA shortcut with its latest HIV combo

Last year, Gilead Sciences paid $125 million for a ticket promising a speedy FDA review. Now the Big Biotech is cashing it in, submitting a combination HIV treatment for approval and lining up for a truncated regulatory process.

Proteus gains first FDA clearance specifically for measuring medication adherence

Proteus Digital Health first won an FDA nod for its ingestible sensor in 2012. But now it's gained an expansion of its label from the agency that indicates that the product can be used in the measurement of medication adherence. That makes it the first and only medical device to have gained this particular indication from the FDA.

GlySure gets CE mark for first continuous intravascular glucose monitor for hospital use

Managing blood glucose levels tightly helps improve morbidity and mortality rates among diabetics. That's particularly true for diabetics who have other major health problems. Now British startup GlySure has gained a CE mark specifically for use in intensive care units with adult cardiac surgery patients. Until now, blood glucose management for these critically ill patients often required frequent manual monitoring by the hospital staff.

Boehringer gets respiratory boost with batch of Spiolto nods in EU

When Boehringer Ingelheim's COPD drug Stiolto Respimat won U.S. approval early last month, the company's head of pharma marketing and sales, Allan Hillgrove, acknowledged that payer arm-twisting happening stateside may make pricing tough. But now, the German drugmaker has nabbed some European approvals that should give the drug a lift.

Stormy Australia hearings on transfer pricing by drug firms invoke Sergeant Schultz

Multinational drug firms in Australia faced a string of barbs in hearings held by a Senate panel into transfer pricing that included a reference to a fictitious German World War II prison camp guard.

China's Universal prices IPO at $447M as HKEx shows attraction to healthcare

China's Universal Medical Financial & Technical Advisory Services priced its IPO at $447 million, FinanceAsia reported, showing further the ability of healthcare-focused companies, including biotechs, to raise cash on the Hong Kong Stock Exchange.

Listen up, eardrop makers: FDA says get products approved or face prosecution

On Wednesday, the FDA announced a federal permanent injunction against a company that continued to sell suppositories after being repeatedly warned they needed to be evaluated and approved by the FDA. Separately, it warned makers of unapproved children's eardrops they may face prosecution if they don't stop selling them.