LEGAL AND REGULATORY
FDA advisers vote against BioMarin's Duchenne drug; the FDA approves Lilly's lung-cancer drug; criticism mounts for Pfizer's proposed deal with Allergan
Opdivo receives another indication; increasing generic prescriptions may boost patient adherence; hep.-C drugs should be prescribed during earlier stages of disease
To hear politicians tell it—especially the ones seeking President Obama's job—pharma is motivated by profit and needs to be brought to heel. The reality of the situation, inside DC and out, is just a tad more complex. Larry Dobrow takes a closer look at what might be coming down the policy pipeline Illustration by Alex Fine
Califf defends his past; Drug spending to increase by 4%-7% per year through 2020; Samsung Bioepis's Enbrel biosimilar faces decision-date Friday
The embroiled drugmaker now faces allegations that it violated securities law and that its staff was embedded in Philidor's day-to-day operations.
Not-for-profit ranks Gilead Sciences and Sanofi as the lowest-scoring drugmakers in terms of clinical trial transparency; Perrigo shareholders to vote on Mylan deal; new Valeant allegations
Dr. Reddy's is blocked from selling generic purple Nexium; the FDA approves Roche's melanoma drug; Novartis says Entresto keeps heart-failure patients from being readmitted to the hospital
The drugmaker had sued the FDA in September over marketing restrictions for its painkiller, Exparel.
Novartis to pay $390 million to settle a lawsuit over drug sales; researchers examine why some patients respond better than others to immuno-oncology drugs; experimental heart-failure drug to get late-stage trial
Valeant made the disclosure as it defends its accounting practices and relationships with specialty pharmacies.