Topic:

Regulatory

Latest Headlines

Latest Headlines

NICE says 'too pricey' to Celgene's Abraxane combo for pancreatic cancer

The U.K.'s cost-effectiveness watchdogs are cracking down on expensive cancer treatments yet again. This time the ax is falling on Celgene, which learned today that the National Institute for Health and Care Excellence (NICE) won't back the company's drug Abraxane to treat metastatic pancreatic cancer.

FTC takes after AbbVie, Teva for pay-for-delay deal on AndroGel

Even as the FDA is questioning the widespread use of testosterone-boosting drugs for men, the Federal Trade Commission has sued AbbVie and Teva Pharmaceutical Industries for keeping a generic of one out of their reach for years. It is one of the first actions brought by the FTC since the Supreme Court last year said that so-called pay-for-delay deals are not inherently illegal.

Europe opens up big new market for Roche's RA therapy RoActemra

Roche just won access to a larger market for its RoActemra treatment for rheumatoid arthritis.

U.K. watchdogs hope to tap social media for drug-safety purposes

Now, it's U.K. drug regulators who are devising plans to eavesdrop on social media. But unlike the FDA, which plans to monitor the world of online sharing to see whether its communications are hitting their targets, the Medicines and Healthcare Products Regulatory Agency plans to search for drug safety info.

Sales layoffs may be ahead as Hospira loses fight against Precedex generics

Hospira's reprieve from generic Precedex competition was short-lived. The U.S. district court that temporarily stopped Precedex generics has now decided to let the copycats roll. And that could mean Hospira will soon be sharpening its job-cutting ax.

First Dx for kidney failure approved by FDA

The FDA cleared the first and only diagnostic for acute kidney injury today, Astute Medical announced. A recent study found that hospitalized patients who got AKI had a 30% mortality rate at one year, twice that of a heart attack.

FDA faces pressure to green-light generic versions of AZ's pricey Nexium

Back in 2008, Indian generics maker Ranbaxy made a deal with AstraZeneca to launch its Nexium copycat in May of this year. So why are Americans still unable to buy cheap versions of the blockbuster heartburn pill, which brought in more than $2 billion in U.S. sales last year?

J&J ordered to fork over $3M in vaginal mesh case

Johnson & Johnson's Ethicon unit lost a battle in its ongoing vaginal mesh litigation as a federal jury in West Virginia ordered the company to pay $3.27 million to a woman who claimed the device caused undue pain and serious side effects.

FDA, DOJ arrest NECC pharmacist about to leave the country

Federal authorities have arrested a pharmacist that worked for the now bankrupt New England Compounding Center. The compounder's manufacturing failures are believed to be responsible for a fungal meningitis outbreak in 2012 that killed 64 people and sickened 751. 

FDA clears Otoharmonic's iPad/iPod app to treat tinnitus

The FDA has given clearance to startup Otoharmonics for its iPad and iPod Touch application that uses sound therapy to teach the brain to ignore persistent ringing caused by tinnitus.