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.
With two of its respiratory meds under review for potential approvals this year, Theravance stands to grow up significantly in 2013, giving more reasons for large pharma companies to come knocking. GlaxoSmithKline, Theravance's longtime lung drug partner and owner of 27% of the biotech's stock, rose again to the top of the list of potential acquirers in speculation this week. Read the full story >>
The FDA has pledged to do its part to revitalize the ailing antibiotics business, but industry watchers want to see some action from the agency after seeing the damage from measures that have hurt the economics of antibiotics development.
Theravance has won a partial victory in moving along its infection-fighting drug Vibativ.
South San Francisco-based Theravance will put its discovery unit to work on a $153 million deal to find new drugs for cardiovascular disease for Merck. In the pact Theravance gets $5 million upfront and the rest in potential milestones.
Theravance ($THRX) has found a partner to bolster development of an experimental compound against gastrointestinal disorders. Italian drugmaker Alpha Wassermann and the South San Francisco biotech have laid out a mid-stage development program to advance the compound, velusetrag or TD-5108, to treat patients with gastroparesis.