Pfizer has been lobbying the FDA to back off of the black-box warning on its stop-smoking drug Chantix. But patient groups and others have been pushing back--including a panel of FDA advisers, which voted last year to keep the agency's boldest warning on Chantix's official label.
Billionaire investor Bill Ackman spent quite a large chunk of 2014 talking up Valeant Pharmaceuticals and its business model--and now, he's putting his money where his mouth is.
Bristol-Myers Squibb's incoming CEO will get quite a raise with his new job. But it's likely to be awhile till Giovanni Caforio, now the company's chief operating officer, sees his pay catch up to that of current chief Lamberto Andreotti.
Concordia Healthcare is snatching up Covis Pharma's pharma and injectables units for $1.2 billion in cash, beefing ups its generics portfolio and riding the recent wave of pharma M&A.
The FDA offers incentives for developing products that target life-threatening infections, and Astellas just became the latest drugmaker to take advantage.
When Opdivo showed it could prolong the lives of lung cancer patients, Bristol-Myers Squibb quickly broadcast the data. And the pharma world was sufficiently impressed. But the FDA was so impressed with the survival data on the new immunotherapy, it was already working on a new approval for the drug.
As AbbVie's $21 billion deal to buy Pharmacyclics shows, drugmakers aren't scared to shell out for cancer drugs--and they're not worried about pricing pressure holding their purchases back. Could PD-1 pioneer Bristol-Myers Squibb be next?
GlaxoSmithKline is breaking out the broom once again to clean up its act in China. It's dismissed more than 100 employees there for misconduct in part of what it calls a "zero tolerance" approach--but the fired workers aren't taking their dismissal lying down.
Novartis execs are rolling up their sleeves for another round of cost cuts. "Very significant" cost cuts, CEO Joe Jimenez tells the Financial Times, partly from the company's ongoing overhaul in back-office operations--and partly from its sale-and-swap with GlaxoSmithKline, which closed last week.
Roche handled hazardous chemicals at its now-shuttered facility in Nutley, NJ--and its neighbors say the company didn't do it properly.
It's just Friday, but the Monday morning quarterbacking on AbbVie's Pharmacyclics buy is in full swing. Did AbbVie overpay at $21 billion? Should it have let Johnson & Johnson take the prize instead? Does the rich deal for Pharmacyclics spell trouble for pharmas looking to make biotech buys? And really, did AbbVie overpay?
It's more bad news for Eli Lilly's Alimta in Europe. After losing a patent fight last year with Actavis in England, the Indianapolis drugmaker has now lost another in Germany, paving the way for knockoff versions of its top drug there.
It's been a long, long regulatory road, but the first FDA-approved biosimilar--a copy of Amgen's Neupogen from Novartis' generics unit, Sandoz--is finally here. But that doesn't mean it'll catch on right away, as the Swiss pharma's CEO has been first to admit.
Chalk up another success for a drugmaker setting one of its units free. Novo Nordisk's newly public IT business got off to a flying start Friday, its first day on the Copenhagen stock market, with shares rising by as much as 44%, Reuters reports.
Bristol-Myers Squibb and Pfizer got a positive recommendation from the U.K.'s cost gatekeeper for its new-age clot-fighter Eliquis, giving the companies a boost as they chase $3 billion in sales for the drug and compete with rivals Pradaxa and Xarelto.
To help healthcare providers more easily track drug shortages, the FDA has released a mobile app that will allow anyone to use a smartphone to look up current shortages and discontinuations as well as shortages that have been resolved.
South Africa-based Aspen Pharmacare is looking for more overseas products and companies to snap up. CEO Stephen Saad tells Reuters that he's "looking the hardest" in Asia.
Mallinckrodt will slap down $2.3 billion to buy Ikaria, a privately held drug company, and its respiratory med for babies in neonatal ICUs. The deal will help Mallinckrodt grow its hospital drugs business, with a $150 million boost to revenue this year.
Call it the copay dance. Payers use high copays to steer patients away from pricey brands and toward cheaper alternatives, or even cheaper generics. Drugmakers use copay coupons and cards to steer patients back on course toward their brands.
After nixing his company's $55 billion deal for Shire last fall, AbbVie CEO Richard Gonzalez reminded investors that his company still had the "wherewithal to be active on the M&A front." Now, he's putting his money where his mouth is--and shelling out $21 billion for cancer drugmaker Pharmacyclics.