The FDA has held off approval of a new Eli Lilly diabetes drug until partner Boehringer Ingelheim fixes problems at a plant that last year was slapped with a warning letter.
Johnson & Johnson and AstraZeneca will just have to duke it out for share of the market for SGLT2 treatments for diabetes. A potential third competitor from Eli Lilly and Boehringer Ingelheim, empagliflozin, failed to win FDA approval, thanks to problems at a Boehringer manufacturing plant.
The FDA has rejected one of Eli Lilly's top drug prospects partnered with Boehringer Ingelheim, saying that its SGLT2 drug empagliflozin could not be approved for marketing before Boehringer fixed "deficiencies" at one of its manufacturing facilities.
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.
A voluntary recall was issued Friday after there was a report of a single visible glass particle in a vial in a lot that was produced for Genco Pharmaceutical Services.
Which pharma companies are getting it right when it comes to social media? As far as Twitter is concerned, Boehringer Ingelheim is up there.
Biopharma has encountered more critics than cheerleaders as it has cautiously edged into social media, but Boehringer Ingelheim has recently won a high-profile supporter: Twitter. In a case study, the social network praised Boehringer's use of its platform.
Pradaxa has become a bigger legal headache for Boehringer Ingelheim. The German drugmaker says it's facing more than 2,000 lawsuits in the U.S., filed by patients claiming the anticoagulant drug caused severe or fatal bleeding.
Recently unsealed company documents that are part of litigation over the bleeding risks of Boehringer Ingelheim's blockbuster blood thinner Pradaxa show that officials wanted to soften, or even kill, an internal report that suggested a small group of patients would benefit from regular blood monitoring for bleeding risks, The New York Times reports.
When the FDA began drafting plans to meet Congress' drug safety legislation, the agency predicted that postmarket surveillance would ultimately become as big a task as premarket review. Since then, the system those plans spawned--named Mini-Sentinel--has given credence to the prediction by growing to cover more than 160 million patients.