Vertex’s Kalydeco scores FDA panel rec in R117H. Are bigger nods next?

Despite falling short of its primary endpoint in a trial to examine its effects in cystic fibrosis patients with the R117H mutation, Vertex's Kalydeco has scored an FDA advisory committee recommendation for approval in that population. And the way some see it, that's a sign of much, much bigger approvals to come.

Vertex’ Kalydeco scores FDA panel rec in R117H. Are bigger nods next?

Despite falling short of its primary endpoint in a trial to examine its effects in cystic fibrosis patients with the R117H mutation, Vertex' Kalydeco has scored an FDA advisory committee recommendation for approval in that population. And the way some see it, that's a sign of much, much bigger approvals to come.

Novartis hopes to rev up Theraflu relaunch with TV celeb Nick Cannon

Novartis has the face to launch a Theraflu comeback: Entertainer Nick Cannon, who's advising parents to get their kids ready for flu season by getting them vaccinated and stocking up on the over-the-counter remedy.

Top investor bails on Valeant bid, backing Allergan-Shire combo instead

AbbVie faces stumbling blocks after cutting cord on $55B Shire deal

Days after AbbVie recommened shareholders vote against its proposed $55 billion deal for Shire, the company officially cut the cord and terminated its pending merger. And while Shire has big plans to succeed solo, AbbVie could face a few stumbling blocks without the Dublin-based company by its side.

It’s back to basics in M&A, and that’s a good thing, Actelion CEO says

Will Pfizer rebid for AstraZeneca? Keep an eye on U.S. midterm election for clues

Will Pfizer come back at AstraZeneca? That's been the question of the summer, especially since the U.S. Treasury Department rolled out new rules for tax-inversion deals.

Shire CFO jumps ship as post-AbbVie deal talk heats up

Shire is casting off on its own after AbbVie pulled the plug on its $55 billion proposed deal. But the Dublin-based company is losing more than just a merger, as one of its top dogs is jumping ship and joining a U.K. water firm.

Addiction-riddled Kentucky out for blood in $1B suit against OxyContin-maker Purdue

Kalydeco in R117H patients? As AdComm nears, Vertex drug faces doubts

Vertex' orphan drug Kalydeco boasts a comparatively small patient pool that the drugmaker is trying to swell, with an eye on adding cystic fibrosis patients with the R117H mutation. But first, it'll have to get the FDA's OK, and new briefing documents suggest the agency still has some doubts.

View sitemap

ob_end_flush();