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. Read More
The U.S. biopharma and med-tech industries are adding their voice to that of Gilead Sciences Inc. in urging the California Supreme Court to review the Gilead Tenofovir Cases, which seek to hold the drug company liable for how and when it developed its pipeline of HIV drugs. Read More
Voydeya (danicopan), from Alexion, Astrazeneca Rare Disease, racked up its second global approval as the U.S. FDA greenlit it as an add-on therapy for treating extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH), a crowded market with several already approved treatments and more in development. Read More
The possibility for expanding Bristol Myers Squibb Co.’s S1P modulator, Zeposia (ozanimod), into Crohn’s disease took a hit on disappointing data from the initial analysis of its Yellowstone study, the first of two phase III trials. Results showed the study failed to meet the primary endpoint, defined as clinical remission as measured by the Crohn’s Disease Activity Index at week 12. Read More
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. Read More
South Korean confectionary giant Orion Holdings Inc. has completed the acquisition of antibody-drug conjugate developer Ligachem Biosciences Inc., which recently changed its name from Legochem Bioscience Inc. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeovian, Aurion, Biodexa, Iambic, Ironwood, Lipocine, Neurocrine, Sagimet, TFF, Virion. Read More
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. Read More
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. Read More
