Merus pulls forward target date for solid tumor data, reiterates intent to file IPO

Nick Paul Taylor Merus has shaved months off the date on which it expects to release data from a Phase I/II trial of its lead bispecific antibody in HER2-expressing solid tumors. The ...

U.K. cost watchdog nixes pricey biologics for moderate rheumatoid arthritis

Carly Helfand The U.K.'s cost effectiveness gatekeepers are giving their final blessing to a slew of rheumatoid arthritis biologics–but only for patients with advanced forms ...

Codiak piles on more venture cash, amassing $92M for exosome R&D

Damian Garde Startup Codiak BioSciences got off the ground in November with ambitious plans to turn exosomes into cancer therapies and venture commitments totaling more than $ 80 million. ...

Amgen’s Humira biosim is one step closer to FDA approval. But how close is it to market?

Carly Helfand On Monday, Amgen said the FDA had accepted its application for its biosimilar of AbbVie's Humira, so-called ABP 501–but earlier this month, the U.S. Patent ...

Galapagos’ bowel drug misses the mark in Phase II

Damian Garde Belgian biotech Galapagos is shutting down an ulcerative colitis program after its top prospect failed to make a difference in a Phase II trial, putting off plans for late-stage ...

Anti-PD-1? Well, no, says Medivation as a partial hold forces a halt to ‘pivotal’ cancer study

John Carroll When Medivation bought out the rights to CureTech's pidilizumab, it trumpeted its entry into checkpoint inhibition with a drug that aimed right at PD-1, unleashing ...

Amgen’s Humira biosimilar nears FDA nod, but legal hurdles remain

Damian Garde Amgen's take on AbbVie's top-selling inflammation treatment is in line for FDA approval this year, but a patent fight between the two companies could keep it off ...

With a Duchenne MD patient struggling for life, little Akashi suspends study

John Carroll Nonprofit-backed Akashi Therapeutics has suspended a trial of its lead drug for Duchenne muscular dystrophy after a patient on the highest dose experienced "life-threatening ...

China’s CARsgen raises $30M for CAR-T work

John Carroll Shanghai-based CARsgen Therapeutics has rounded up a $ 30 million B round to advance its work on CAR-T therapies. The biotech has been working on personalized CAR-T programs, ...

Novo Nordisk rolls out long-awaited Tresiba, aiming for blockbuster market share

Tracy Staton Novo Nordisk finally launched its next-gen diabetes treatment Tresiba in the U.S., approved by the FDA last September. The Danish drugmaker has high hopes ...

Indian pharma mulls deal for U.S. injectables maker Sagent Pharma

Emily Wasserman U.S. injectables maker Sagent Pharmaceuticals is considering putting itself on the chopping block, and if or when it does, at least 5 Indian drugmakers could come calling. FiercePharma ...

Novartis adds 100 jobs at Lek site in Slovenia as it muscles up on biosimilars

Eric Palmer Novartis was the first drugmaker to get a biosimilar approved in the U.S. and has set itself up to be a major player in the growth of the biologic copies. That is going ...
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