Acorda Therapeutics Inc. has filed for bankruptcy and agreed to sell its assets, including rights to its three commercialized drugs, to German biopharma Merz Therapeutics GmbH for $185 million. Palo Alto, Calif.-based Eiger Biopharmaceuticals Inc. also filed for bankruptcy.
Yes, even a phase III protocol for a “failed” trial can constitute prior art, the U.S. Court of Appeals for the Federal Circuit told a lower court April 1 when it returned Janssen Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc.’s patent squabble for a do-over.
Trouble continues to dog Verve Therapeutics Inc.’s base editor of the PCSK9 gene, VERVE-101, so the company paused enrollment in a phase Ib study in cholesterol lowering to focus on the similarly designed VERVE-102.
Phase II/III results from Gritstone Bio Inc. with Granite, a personalized neoantigen cancer vaccine for colorectal cancer, turned up the opposite of what some investors expected, and the company’s shares (NASDAQ:GRTS) ended April 2 at $1.20, down $1.15, or 49%.
Jumping in for the first time to the hot antibody-drug conjugate (ADC) space, Paris-based Ipsen SA pulled in exclusive global rights to a preclinical ROR1-targeting candidate from Sutro Biopharma Inc. in a deal worth up to $900 million. STRO-003, the first ADC to join Ipsen’s portfolio, contains an anti-ROR1 human IgG1 antibody (SP-11385) conjugated to an exatecan warhead, or payload.
Beijing- and Shanghai-based Sperogenix Therapeutics Ltd. said that China’s regulatory agency accepted the NDA filing and granted priority review of Agamree (vamorolone) for Duchenne muscular dystrophy on March 26.
Disc Medicine Inc. CEO John Quisel said that top-line phase II findings from the study called Aurora with bitopertin in erythropoietic protoporphyria are “hard for us to interpret. This package of data is something that we’re going to have to sort through,” and the Watertown, Mass.-based firm expects to talk with the U.S. FDA about next steps in the second half of this year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Aldeyra, Gilead, Hutchmed, Merck, Milestone, Nested, Projenx, PTC.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2seventy, Beigene, China Medical Systems, Coastar, Confo, Eisai, Elevation, Genfleet, Globestar, Incyte, Ipsen, Kaken, Launch, Merrimack, Mustang, Nexera, Rakovina, Realta, Sohm, Sosei, Teva, Regeneron.
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