Latest Headlines

Latest Headlines

NEJM: FDA's proposed risk-disclosure guidelines still aren't enough

As the FDA again reviews its guidance on disclosing prescription drug risk information, two New England Journal of Medicine articles are suspicious that new guidelines would change much for patients.

Not so fast, Hillary. Ad industry will fight with pharma against DTC tax moves

Hillary Clinton's plan to take away drugmakers' advertising tax deductions gets a resounding "no" from ad industry trade groups. While the ad executives aren't taking a stance on the rest of Clinton's drug-pricing plan, the advertising proposal gets a thumbs down.

Pathway Genomics comes under FDA fire for liquid biopsy marketing

The FDA is cracking down on Pathway Genomics for improperly marketing its liquid biopsy test, a couple of weeks after the company rolled out its product directly to consumers for the early detection of cancer.

Apotex recalls cevimeline hydrochloride drugs made in India as FDA notes stability issues

Within weeks of getting a conditional nod to resume shipments from two of the company's manufacturing units in India, Canada's largest generics maker has recalled 117,644 bottles of cevimeline hydrochloride capsules in the U.S. that were made by the company's Indian arm, Apotex Research, the Business Standard newspaper reports.

India's Sun Pharma research arm sees FDA nod for Elepsia XR yanked by FDA on manufacturing

The research arm of Sun Pharmaceutical Industries has seen its license for epilepsy drug Elepsia XR revoked by the U.S. FDA because of manufacturing violations at its production site, dealing a blow to its aims of moving beyond generics.

Novo scores a game-changing diabetes approval, reversing an embarrassing rejection

Two years after the FDA's shock rejection of Novo Nordisk's next-generation insulin, the Danish drugmaker has convinced U.S. regulators to change their tune, setting the stage for a market duel with Sanofi.

JDRF, ADA redefine Type 1 diabetes framework to encourage early diagnosis, prevention

In an effort aimed at encouraging earlier diagnosis and even potentially prevention for Type 1 diabetes, the JDRF and the American Diabetes Association have published a new evaluation of the presymptomatic staging of Type 1 diabetes.

Roche, Boehringer and Gilead line up for EU drug approvals

The European Medicines Agency is moving toward approving a trio of novel medicines from Roche, Boehringer Ingelheim and Gilead Sciences, handing down positive recommendations for each.

Novartis scores EU rec for blockbuster-to-be Entresto

Novartis has predicted that its launch of newly FDA-approved heart failure med Entresto would be its "most exciting" ever. And now, it's one step closer to bringing that excitement to Europe.

Sientra off by more than 50% after it discloses CE mark suspension for its contract manufacturer

Breast implant company Sientra saw its valuation cut in half on news that its contract manufacturer Silimed has had its CE mark suspended by the U.K. Department of Health. The move came after German regulators conducted an inspection of a Brazilian manufacturing plant--and regulators found that "the surfaces of some implants were contaminated with particles."