Boehringer Ingelheim GmbH didn’t disclose a data analysis to U.S. regulators that indicated the blood-thinner Pradaxa may have caused more fatal bleeding after it was cleared for sale than the drug did in a study used to win approval, unsealed court filings show.
Medtronic Inc. said it will make the data on its embattled bone-growth product Infuse available to the public and pay for two independent analyses of the information in a move the company says may set a new industry standard.
A new class of cholesterol-lowering medicines from Pfizer Inc. and Amgen Inc. may struggle to meet sales projections, as latest treatment guidelines suggest doctors should prescribe only drugs proven to help the heart.
GlaxoSmithKline Plc ’s study of its once best-selling diabetes pill Avandia doesn’t prove the drug is safe, according to U.S. regulators considering whether to recall it amid doctors’ concerns it causes heart complications.
General Mills Inc. ’s Cheerios are among the foods that should be held to the same scientific standards as pharmaceuticals when promoted as having health benefits, a report ordered by U.S. regulators said today.
Medtronic Inc. ghost-wrote sections of medical papers and paid physician authors hundreds of millions of dollars in “consulting fees” to promote its bone- growth product Infuse, a U.S. Senate investigation found.