In the latest salvo against the growing problem of prescription drug abuse and misuse, the FDA approved a classwide risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid drugs.
WASHINGTON – Although the SEC told Congress it was doing what it could to amp up the rulemaking process to implement the Jumpstart Our Business Startups (JOBS) Act, it didn't hit its first deadline.
The FTC seems to have come down with a bad case of star envy. Not content with its supporting role as implementer of laws duly passed by Congress, the agency is intent on rewriting the script, casting itself as headliner hero, executive producer, star-making director and congratulatory movie critic. (Bring up music intro.) In its colorized remake of the budget-busting melodrama How Government Functions, the FTC plays the white-hatted good guy come to cut down the gang of biopharma villains while the local sheriff (Congress) sits idly by, his pockets stuffed with Big Pharma bribes. The action climaxes as the...
In determining that the Affordable Care Act (ACA) was constitutional, the Supreme Court last week blew away a cloud of uncertainty that has been hanging over the biopharma industry for the past two years. But other clouds are gathering.
Stop waiting and start implementing. That's the message the Supreme Court sent to drugmakers Thursday when it ruled the Affordable Care Act (ACA) meets constitutional muster.
WASHINGTON – A week ahead of its self-imposed July 4 deadline, the Senate overwhelmingly passed the FDA Safety and Innovation Act (FDASIA) Tuesday, reauthorizing PDUFA for another five years. Now all the user-fee package needs is the president's signature so it can go into effect Oct. 1.
Two days ahead of Wednesday's PDUFA date for obesity drug lorcaserin, shares of Arena Pharmaceuticals Inc. continued to slide after a roller coaster of a ride last week.
Anticipation is making a lot of Supreme Court watchers wait a few more days to see if the court will release its opinion on the Affordable Care Act (ACA) this term.
On their way to the European market with Elelyso, Pfizer Inc. and Protalix BioTherapeutics Inc. tripped over Shire plc's marketing exclusivity for Vpriv.
WASHINGTON – Drug researchers counting on National Institutes of Health (NIH) support could be in for a bit of a drought next year, as a federal budget sequester, set to go into effect Jan. 1, 2013, would dry up funding for about 2,300 grants – one-fourth of the grants the NIH typically awards.
