Drugmaker Questcor has run into questions--sometimes from regulators--about sales and marketing for its high-priced drug for autoimmune disorders, H.P. Acthar Gel. And every step of the way, short seller Citron Research has been there to trumpet those mishaps.
Generic drug companies are fighting back against a new FDA proposal that would require them to update product labeling as soon as they learn of new safety information. The rule would essentially overturn a 30-year-old law--and put companies on the hook for liability lawsuits.
Amarin, which has faced a series of setbacks getting its fish oil pill to market, is lashing out at the FDA for some of its problems, Bloomberg reports.
The FDA has granted its fast-track status to Actelion's Phase III drug for C. difficile-related diarrhea, promising a shorter path to approval for the antibiotic treatment.
The FDA has reduced the number of new drug shortages considerably, and hospitals have gotten much better at responding when they occur. But the total number of drug shortages continues to grow, and patients continue to suffer as a result.
It's Johnson & Johnson's last stand in Arkansas. The drugmaker has its chance Thursday to persuade the Arkansas Supreme Court to toss out the $1.2 billion judgment awarded in a court fight over Risperdal marketing.
With its potential for addiction and its lack of abuse-deterrent features, Zogenix's Zohydro painkiller had its critics even before its regulatory green light in October. Now, with the powerful product on the market, a coalition of activists is taking its protest to the next level.
Merck's Januvia, Novo Nordisk's Victoza and their brethren are in the clear. After a new round of safety reviews, U.S. and European regulators found little evidence that widely used diabetes drugs known as incretin mimetics cause pancreatitis or pancreatic cancer.
Once again, the U.S. government has tallied up its health-fraud haul, and once again, its prosecutions set a record. And as usual, the pharma business accounted for the lion's share of the total.
Drugmakers should clean out their data closets and turn over to regulators every bit of research and analysis they have, according to some healthcare experts, who point to documents released in litigation against Boehringer Ingelheim, with the company's blockbuster anticoagulant Pradaxa as prime evidence.