A European Medicines Agency panel recommended approving a diabetes drug from Boehringer Ingelheim GmbH and Eli Lilly & Co. that was rejected this month in the U.S. because of manufacturing deficiencies.
A diabetes pill developed by Eli Lilly & Co. and Boehringer Ingelheim GmbH was rejected by U.S. regulators because of previously disclosed manufacturing deficiencies at a German plant that hadn’t been resolved.
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.
Boehringer Ingelheim GmbH Chairman Andreas Barner may use product deals and regional acquisitions to fuel growth as the world’s largest family-owned drugmaker faces competition from lower-priced generics.
Evotec AG rose the most in almost two weeks after saying it received a payment of 1.5 million euros ($1.93 million) for achieving a research milestone under an agreement with Boehringer Ingelheim GmbH.
Boehringer Ingelheim GmbH, the German family-owned drugmaker, withheld or failed to preserve “countless” files sought by patients suing over the company’s blood thinner Pradaxa and must pay a fine of almost $1 million, a judge ruled.
Two children with HIV who were treated immediately after birth have no signs of the virus 9 and 23 months later, scientists said in a report that suggests a potential approach to curing HIV-infected babies.
Boehringer Ingelheim said the National Institute for Health and Clinical Excellence in the United Kingdom has issued a Final Appraisal Determination recommending its Pradaxa oral anticoagulant as a treatment option, the company said in an e-mailed statement today. The licensed indication is for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation with one or more risk factors and the institute’s recommendation is without any restrictions within the indication.