Topic:

Regulatory

Latest Headlines

Latest Headlines

Pfizer, Novartis: CDC's MenB nod is too narrow

Pfizer and Novartis have snagged a nod from the CDC's Advisory Committee on Immunization Practices for their recently approved meningitis B vaccines. There's just one problem: It doesn't cover nearly as large a population as the pharma giants would like.

Bayer nabs new Eylea nod to help it toward 2015 sales target

Bayer said earlier this week that it would be counting on eye blockbuster Eylea to provide some serious sales growth in 2015, and now, it has a new indication the company hopes can help it get there.

Paris-based biotech ABIVAX launches pivotal clinical study on hep B candidate in Asia

Paris-based clinical biotech ABIVAX said it has recruited its first patient for an Asia Pacific-based pivotal Phase IIb-III clinical trial of a potential vaccine therapy of chronic hepatitis B.

Japan unit of Novartis sees most sales suspended 15 days over ADR failures

Japan's health ministry on Friday told the local unit of Swiss-based Novartis to suspend most sales operations for just over two weeks.

GSK annual report says China bribery case spawned surge in compliance 'contacts'

It turns out the GlaxoSmithKline whistleblowers who blew the top off the China corruption scandal had hundreds of copycats later on.

China's Tianyin Pharma faces NYSE de-listing on failure to file quarterly report

China's Tianyin Pharmaceutical may be in danger of being de-listed from the New York Stock Exchange for failing to file its latest quarterly report on time.

India's CDSCO board recommends Phase III drug trial waivers for 'well-regulated' therapies

India's Central Drugs Standard Control Organization has recommended new guidelines for Phase III trial drug trial waivers.

Pfizer, Novartis get MenB ACIP nod--but not the one they're really after

Pfizer and Novartis officially have a nod from the CDC's Advisory Committee on Immunization Practices (ACIP) for their recently approved meningitis B vaccines. Problem is, it doesn't cover nearly as large a population as the pharma giants would like.

Boston Scientific launches upgraded endoscope, says it will reduce repeat procedures

Boston Scientific touted its new cleared endoscopic SpyGlass DS Direct Visualization System enabling direct visualization of the biliary tree and pancreatic ducts. With the FDA's 510(k) clearance now in hand, the device can hit the market.

DexCom profitable for the first time, completes FDA submission for smartphone glucose monitor

Continuous glucose monitor company DexCom turned a profit for the first time during the fourth quarter of last year. It also said it completed its FDA submission for its first direct-access smartphone CGM, the G5, which transmits data directly to a smartphone and from the phone to a secure system.