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Pharma channel feed
Highlighting a major shift at the FDA, regulators put Amicus' once-spurned drug on fast track
8 years ago
FDA adds two Roche studies to its growing list of partial clinical holds in wake of Keytruda deaths
8 years ago
Bayer boosted as FDA OKs its PI3K drug Aliqopa for relapsed follicular lymphoma patients
8 years ago
FDA commish cheers on biosimilars as Amgen, Allergan score OK for knockoff of Roche's Avastin
8 years ago
The FDA just unveiled its new, pricier fee schedule to review new drugs
8 years ago
Mustang ties the knot with Fred Hutch on next-gen CAR-T for lymphoma
8 years ago
R&D
Looking for an I/O edge, Bristol-Myers fronts $105M to partner with Halozyme as Roche expands pact
8 years ago
Otonomy brings out the ax after a catastrophic PhIII failure
8 years ago
R&D
Mylan attacks Allergan over its Mohawk-allied patent strategy — but the CEO is sticking to his guns
8 years ago
People
Scott Gottlieb is closing a big loophole in the orphan drug law
8 years ago
Alexion is reorganizing R&D, axing 600-plus jobs and moving HQ to Boston as execs prep deal spree
8 years ago
R&D
WATCH: Scott Gottlieb vows to shake up the FDA, backing a trend toward faster drug development
8 years ago
Struggling in R&D, GSK lines up an FDA pitch on COPD with mixed data
8 years ago
Sanofi, Regeneron earn ‘breakthrough’ status for a fast-track drug out to prove PD-1 dominance
8 years ago
Following up on Trump's orders, the FDA wants to know: which regulations and paperwork requirements need to go?
8 years ago
Eli Lilly slashes R&D jobs, shutters 2 research sites as it looks to cut 3,500 staffers worldwide
8 years ago
R&D
Ramping back up on oncology, GSK takes an option on Adaptimmune’s TCR cancer drug
8 years ago
Alnylam slammed after patient death forces investigators to halt dosing of fitusiran, raising new safety fears
8 years ago
Safety fears spur FDA to pause checkpoint combo studies by Bristol-Myers, Celgene
8 years ago
Sarepta readies FDA pitch after a small study spotlights 1% dystrophin add for golodirsen in Duchenne MD
8 years ago
R&D
Emboldened by recent R&D successes, Merck KGaA looks at selling off $1B-plus consumer division
8 years ago
Deals
Troubled Acorda hurries to bar the door against a takeover attempt
8 years ago
Neurotoxicity kills a CAR-T rival pushed by J&J, MacroGenics in $700M deal
8 years ago
Feds scoop up a band of biotech insiders who allegedly bagged a windfall, and now criminal charges
8 years ago
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