A Lonza plant in the U.S. has been struggling for 18 months to get its manufacturing practices back up to FDA expectations. But the shortcomings are now leading to shortages for one of its key clients.
French drugmaker Ipsen says shortages of its orphan drug Increlex appear inevitable because of ongoing issues at Lonza plant in the U.S. The drug is used to treat a rare condition in children called IGF-1 deficiency, which results in them being very short for their age.
Ipsen is closing a tumultuous foray into the hemophilia area. With its broke biotech partner Inspiration Biopharmaceuticals, Ipsen has agreed to sell a hemophilia drug candidate placed on clinical hold by the FDA last year to Cangene in a deal worth up to $55.9 million in upfront and commercial milestone money.
Baxter International ($BAX) is grabbing a hemophilia A candidate in late-stage development from partners whose collaboration ran aground last year.
Four months ago Inspiration Biopharmaceuticals was preparing for its commercial launch of a late-stage hemophilia therapy. Then in July the FDA clamped a clinical hold on the lead program and today the Cambridge, MA-based biotech's partner and primary financial backer Ipsen ($IPN) revealed that Inspiration had filed for Chapter 11 bankruptcy protection as it prepared for a sale of its assets through the courts.
A little more than a month after regulators clamped a clinical hold on two trials of a leading hemophilia treatment, Inspiration Biopharmaceuticals has restructured its close pact with France's Ipsen, garnering a fresh, $50 million buy-in with another $150 million in milestones up for grabs.
Ipsen's big plans for a new hemophilia drug ran into an unexpected road block today. The French biotech says that the FDA ordered a hold on two late-stage studies of IB1001 after its partner, the U.S. biotech Inspiration Biopharmaceuticals, found that patients taking the treatment developed antibodies to a protein in it.
Last year the top 10 biotechs in the world spent $10.2 billion on R&D, up a whopping 13% over their $8.9 billion track record in 2010.
After burning through more than $122 million, the late-stage osteoporosis drug developer Radius Health is filing to go public in the hope of raising up to $86 million. Radius is betting that it can
Trouble flows downstream swiftly when a CMO finds itself in trouble. Just days after Lonza fired its CEO as it finds itself under the microscope after a warning letter from the FDA on one of its...