Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

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.

Wall Street endorses Cyberonics, Sorin $3B merger to become neuromodulation, cardiac surgery player

Neuromodulation company Cyberonics and cardiovascular device player Sorin in an all-stock deal that now values the combination at $3 billion.

FDA warns manufacturer of failing to report corrections to its device disinfection system

The FDA has issued a stern warning to infection control specialist Cenorin, advising the company to correct violations such as failing to notify the FDA of a correction sent to users of its medical device disinfection system.

New Jersey compounder indicted over unsanitary manufacturing

The FDA has decided that not only were the operations of New Jersey-based Med Prep Consulting unsterile, they were illegal.

Actavis wins FDA approval for a new 'superbug' antibiotic

Actavis won the FDA's blessing for a new combination antibiotic treatment targeting drug-resistant infections, setting the stage for a showdown with Merck and its $9.5 billion splash into the field.

Wockhardt hit with new FDA concerns at banned plant

FDA inspectors returned to a Wockhardt plant in Waluj that it banned in 2013 and weren't impressed by what they found during the weeklong inspection. New concerns were raised.

FDA OKs Sanofi's Toujeo. Will a diabetes drug price war follow?

Sanofi has received the FDA marketing approval it badly needed for the long-acting basal insulin Toujeo, a product designed to preserve its multibillion-dollar franchise revenue from Lantus. But at least one prominent analyst was quick to question its impact, noting that the label will offer little compelling reason for a switch from the established market blockbuster. And that is likely to set up some early price discounting that will further roil the huge and growing diabetes market for all the key players.