After a manufacturing issue scuttled their first attempt, Eli Lilly and Boehringer Ingelheim have won the FDA's blessing to market their new diabetes drug, a late entrant into a crowded space.
The FDA is changing its tune on Jardiance, a Boehringer Ingelheim diabetes med it hasn't been so keen on in the past. After rejecting the drug in the face of a manufacturing issue, the agency Friday gave it approval to treat Type 2 diabetes.
The COPD market has its fair share of contenders, but that's not stopping Boehringer Ingelheim from joining the party. The German drugmaker has nabbed FDA approval for its own entrant, which will go up against the likes of Glaxo's aging giant Advair in a market-share showdown. But despite the competition, BI is hoping it can still find its corner.
The FDA approved Boehringer Ingelheim's COPD treatment Striverdi Respimat, a once-a-day inhaler the German drugmaker hopes can contend in a crowded respiratory market.
Jordan's Hikma has decided to pull the trigger on a deal to take ownership of the Boehringer Ingelheim plant in Bedford, OH, one of the largest sterile manufacturing sites in the world but one that sits idle after quality issues made it too expensive to operate.
When Boehringer Ingelheim closed its troubled sterile manufacturing site in Ohio, which had been the sole supplier of Johnson & Johnson's ovarian cancer drug Doxil, J&J's Janssen unit worked out a deal to take over manufacturing of the bulk drug product for 6 months. Now, with at least a 9-month supply of Doxil in hand, that arrangement is over.
Early this year Zealand Pharma and Boehringer Ingelheim agreed to start over on their three-year-old collaboration to develop a GLP-1 diabetes drug after they decided to part ways on a lead program. Now the Danish biotech will ramp up a second preclinical peptide program with the German pharma company aimed at cardio-metabolic diseases.
A Johnson & Johnson exercise in creative problem solving has paid off for doctors and patients who rely on its ovarian cancer drug Doxil, availability of which has been uncertain for years. Its Janssen unit has accumulated a significant supply after assuming manufacturing at Boehringer Ingelheim plant that otherwise was closed down at the end of the year.
The BMJ has set off a kerfuffle--and a Twitter campaign--over the safety of Boehringer Ingelheim's blockbuster anticoagulant Pradaxa.
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.