Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

California strikes down exemptions to vaccination requirements for schoolchildren

Despite virulent opposition, California Gov. Jerry Brown signed a bill this week making the state the largest requiring schoolchildren--public and private--to be vaccinated unless there is a medical reason not to do so.

GSK's ViiV unit to work with China's Desano to make API of Tivicay for access use

The API of GlaxoSmithKline's HIV therapy Tivicay (dolutegravir) will be made in China by Shanghai-based Desano Pharmaceuticals under a deal with the British drug maker's ViiV Healthcare arm, according to a press release.

Novo Nordisk pulls Tresiba in Germany on pricing dispute

Germany's tough price negotiators went too far for Novo Nordisk. The Danish drugmaker is pulling its new diabetes drug Tresiba off the market after authorities said they'd price the long-acting basal insulin on par with old human insulin injections.