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On second thought, Amicus won't be filing its lead drug this year

Amicus Therapeutics, a biotech comeback story, is walking back plans to submit its rare disease treatment for FDA approval this year, rethinking its whole regulatory strategy after follow-up conversations with the agency.

Sanofi steps deeper into RNAi work, opts in on Alnylam hemophilia drug

Sanofi cautiously waded deeper into RNAi development waters this week, following up on last year's big $700 million buy-in at Alnylam. The pharma giant's Boston subsidiary, Genzyme Sanofi, has picked up some regional rights to the hemophilia treatment ALN-AT3, setting up a complicated set of next steps as Sanofi juggles just what it will opt into and where it wants to leap into commercialization.

XenoPort hits reset after a psoriasis setback, cutting jobs and bailing on R&D

XenoPort has changed its tune on an investigational psoriasis therapy, no longer insisting that the drug's middling efficacy and alarming safety profile merit late-stage development. Instead, the biotech is dumping the drug, cutting payroll and waving away its co-founder and CEO.

Regeneron inks a $325M deal, selling Asian rights to a pain treatment

Regeneron is handing off the Asian rights to its in-development musculoskeletal pain treatment for up to $325 million, handing the antibody over to a subsidiary of Japanese giant Mitsubishi.

After a big IPO, Aduro splurges on a Berkeley R&D hub

Aduro Biotech, months removed from a $119 million IPO, is looking to settle down in Berkeley, leasing a four-story R&D complex as it presses forward with a pipeline of cancer treatments.


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Chalk up another approval for Merck & Co.'s Keytruda. And it's a significant one, as it fights for market share against Bristol-Myers Squibb's Opdivo in the PD-1/PD-L1 field. The FDA Friday gave an accelerated approval for Keytruda for use on advanced non-small cell lung cancer (NSCLC). Opdivo is awaiting an accelerated approval.


GlaxoSmithKline is pinning its hopes on consumer health, a unit whose margins it expects to see at 20% by 2020. But just how does it expect to get there?