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Gilead faces legal action in Massachusetts if it doesn’t cut hep C prices: State AG

Tracy Staton Gilead Sciences is facing more hepatitis C pushback from state officials. The Massachusetts attorney general is warning that it will take legal action against the California-based ...

Big Pharma chalks up victory in Arizona Supreme Court over Rx safety warnings

Emily Wasserman Big Pharma can celebrate a bright point. Arizona's top court ruled that drugmakers don't have an obligation to warn patients directly about safety risks of their ...

Sanofi and Regeneron likely to cough up royalties to end Amgen’s PCSK9 patent suit: Analyst

Tracy Staton One of the hottest races for market share in pharma these days is between Amgen's cholesterol-fighter Repatha and Praluent, from Sanofi and Regeneron. They're apparently ...

Mapi Pharma swings for $50M haul as oft-delayed IPO nears D-Day

Nick Paul Taylor Mapi Pharma has set the terms for its latest crack at listing on Nasdaq. The biotech, which set terms on its first IPO attempt back in April 2014, is aiming to round ...

J&J’s new launches deliver, but overall sales fall short on hep C, strong dollar

Carly Helfand Johnson & Johnson's hep C sales have been nosediving, and the fourth quarter provided more of the same on that front. But in the quarter, a strong dollar ...

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 ...
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