InterMune secured the FDA's breakthrough therapy designation for an in-development treatment for a rare lung disease, evening the regulatory score with rival Boehringer Ingelheim as the two angle for position on the U.S. market.
Boehringer Ingelheim's treatment for a rare and deadly lung disease picked up the FDA's coveted breakthrough therapy designation, a mark that guarantees a speedy regulatory review and could help the company beat its nearest rival to market.
Boehringer Ingelheim's treatment for a rare form of leukemia prolonged survival and beat out chemotherapy in a midstage study on elderly patients, the company said, results that will help make the case for a drug that has already received the FDA's breakthrough therapy designation.
The FDA is guaranteeing a priority review for Boehringer Ingelheim's much-watched treatment for a rare lung disease, likely speeding up the drug's path to market as the German pharma races with biotech InterMune.
To raise awareness about diseases their products treat, some pharma companies launch online marketing campaigns. Others team up with celebrity spokespeople. Boehringer Ingelheim backs Discovery Channel documentaries.
German contractor Evotec has notched another milestone in its years-long arrangement with Boehringer Ingelheim, netting €1 million ($1.4 million) after moving a respiratory compound into preclinical study.
Sanofi's Lantus is not only the best-selling diabetes drug in the world; it is one of the best selling drugs in the world with $7.6 billion in 2013 revenues. But the foundation for this juggernaut is starting to crack. The EU Friday recommended approval a biosimilar of Lantus developed by Eli Lilly and Boehringer Ingelheim.
Eli Lilly and Boehringer Ingelheim have convinced European regulators to recommend their biosimilar of Sanofi's Lantus, the world's top-selling insulin, setting the stage for a near-term approval and launch once the reference product comes off patent next year.
German giant Boehringer Ingelheim is racing to the market with an antidote to its blockbuster blood-thinner Pradaxa, securing the FDA's coveted breakthrough therapy designation for its in-development treatment.
Left far behind in the race to develop cutting-edge drugs for hepatitis C, Boehringer Ingelheim says it is getting out of the field and washing its hands of its lead therapy, faldepravir.