Boehringer Ingelheim wants to be considered part of the major league in global drug R&D. And it's been spending some blockbuster cash on a bid to win a big slate of new drug approvals that could eclipse even the biggest rivals.
Pradaxa may not be leading the new-age anticoagulant market, but it's certainly leading Boehringer Ingelheim's growth efforts. The blockbuster med made significant gains in 2013 to help offset currency effects and keep operating income up in the face of dwindling sales, the company said Tuesday.
Boehringer Ingelheim, determined not to let clot-fighter Pradaxa be outdone by Bayer and Johnson & Johnson's Xarelto, has added a couple of new uses to the drug's label, snagging the FDA's okay to treat deep vein thrombrosis (DVT) and pulmonary embolism (PE) in some patients. But it still has a long way to go--and some safety concerns to dispel--before it can retake the anticoagulant throne.
InterMune watched its shares jump more than 15% after Boehringer Ingelheim posted some mixed results for its rival idiopathic pulmonary fibrosis treatment, all while the biotech has nearly tripled in value over the past 30 days.
European regulators are recommending approval for Boehringer Ingelheim and Eli Lilly's latest diabetes offering, shrugging off a manufacturing issue that spiked the drug's FDA approval and putting the pair in line for third place in a new class of treatments.
The FDA has held off approval of a new Eli Lilly diabetes drug until partner Boehringer Ingelheim fixes problems at a plant that last year was slapped with a warning letter.
Johnson & Johnson and AstraZeneca will just have to duke it out for share of the market for SGLT2 treatments for diabetes. A potential third competitor from Eli Lilly and Boehringer Ingelheim, empagliflozin, failed to win FDA approval, thanks to problems at a Boehringer manufacturing plant.
The FDA has rejected one of Eli Lilly's top drug prospects partnered with Boehringer Ingelheim, saying that its SGLT2 drug empagliflozin could not be approved for marketing before Boehringer fixed "deficiencies" at one of its manufacturing facilities.
Drugmakers should clean out their data closets and turn over to regulators every bit of research and analysis they have, according to some healthcare experts, who point to documents released in litigation against Boehringer Ingelheim, with the company's blockbuster anticoagulant Pradaxa as prime evidence.
A voluntary recall was issued Friday after there was a report of a single visible glass particle in a vial in a lot that was produced for Genco Pharmaceutical Services.