Theravance CEO Rick Winningham put out the word today that its drug TD-9855 flunked a mid-stage study for attention deficit/hyperactivity disorder, adding that the biotech planned to scrap the program while continuing a separate study for fibromyalgia.
GlaxoSmithKline and Theravance have nailed down a solid majority of FDA panel votes in favor of marketing their new COPD therapy Anoro Ellipta. The outside experts voted 11 to 2 this afternoon to endorse the therapy, opening the door to the first of several new drug that will likely wind up duking it out in a tough fight for market share.
GlaxoSmithKline and partner Theravance are closing in on an important advisory committee meeting for their experimental lung drug Anoro Ellipta next week. And FDA staff has noted in a briefing document that the combination therapy for COPD was effective at two doses, Bloomberg reported.
Elan shareholders didn't much care for Kelly Martin's $1 billion royalty deal with Theravance. Or any other deals, for that matter, aside from a share buyback. But that doesn't seem to upset Theravance CEO Rick Winningham even a little bit.
This round goes to Elan. In the ongoing battle for control over the Irish drugmaker, a U.S. court judge gave the company a temporary reprieve from Royalty Pharma's hostile bid of $6.4 billion, Bloomberg reported.
The FDA granted approval to GlaxoSmithKline's new respiratory drug Breo Ellipta. By itself, that's a solid victory for GSK, which needs to build up its respiratory franchise before Advair copycats finally make their way to market. Analysts figure Breo for a blockbuster in the U.S., with peak sales at around $1.3 billion.
Elan has struck a deal to pay a billion dollars for a share of Theravance's future royalties on Breo and a slate of other respiratory drugs now in development, announcing the deal right on the heels of Breo's approval in the U.S. on Friday.
GlaxoSmithKline and Theravance have won FDA approval for their drug Breo Ellipta for treating chronic obstructive pulmonary disease, the third-biggest killer of Americans, the agency announced. The approval comes with an undesirable boxed warning from the agency that LABA therapies boost risk of asthma-related deaths.
Theravance announced Thursday afternoon that it plans to break apart into two publicly traded companies: a company dubbed Royalty Management that will take over Theravance's late-stage respiratory drugs and another called Theravance Biopharma focused on small-molecule R&D.
GlaxoSmithKline took its Breo Ellipta program a step forward Wednesday afternoon, winning the endorsement of an FDA committee for approval of the once-daily treatment for patients with COPD.