After a delay caused by the April complete response letter from the U.S. FDA for Eli Lilly and Co.’s Omvoh (mirikizumab-mrkz), regulators cleared the drug for moderately to severely active ulcerative colitis (UC) in adults. Given by infusion (300 mg/15 mL)/injection (100 mg/mL), Omvoh stands as the first and only interleukin (IL)-23p19 antagonist for the treatment of moderately to severely active UC in adults – as well as the pharma giant’s first drug approval in the space. Read More
Less than two weeks after getting a thumbs-up from the EMA’s Committee for Medicinal Products for Human Use, Santhera Pharmaceutical AG’s vamorolone secured U.S. FDA approval for use in patients, 2 and older, with Duchenne muscular dystrophy (DMD). A first-in-class drug, vamorolone, branded Agamree, is expected to offer a safer alternative to the steroid therapy, which the company has said will remain a foundational treatment of DMD, even with the introduction of gene therapies. Read More
It’s just a discussion next week of Vertex Pharmaceuticals Inc. and Crispr Therapeutics AG’s sickle cell disease (SCD) therapy, with no vote expected from the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee. The FDA isn’t questioning the drug’s efficacy as much as it is concerned about the effects of off-target editing. Read More
Angitia Biopharmaceuticals raised $46 million in a series B round extension, bringing the total raised under the series B to $170 million led by Morningside Group and will enable the company to advance its pipeline of musculoskeletal therapies. Read More
Oncolys Biopharma Inc.’s lead compound Telomelysin (suratadenoturev, OBP-301) met the primary endpoint of exceeding the predefined threshold of local complete response, confirming clinical benefit in a phase II study in locally advanced esophageal cancer combined with radiation. Read More
Fledgling biotechnology company Automera has launched in Singapore with $16 million in series A funding to develop its autophagy-targeting chimera small molecules (AUTACs) platform technology. Automera co-founder and chief technology officer Loong Wang told BioWorld that he and his business partner, Taiyang Zhang, decided to move into the biotechnology space in 2021. Read More
At the 30th Annual Congress of the European Society for Gene and Cell Therapy in Brussels this week, researchers presented both preclinical and clinical strategies for applying gene therapy to a functional HIV cure. At a Wednesday session on Infectious Diseases & Vaccines, Alessio Nahmad, of Tabby Therapeutics Ltd., described using B cells edited to express broadly neutralizing antibodies (bnAbs) 3BNC117 to deliver high titers of antibodies in mice. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dermata, G1, Henlius, Intas, Medicenna, Sanofi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altimmune, Bavarian Nordic, Biosyngen, Immunitybio, Lipocine, Mustang, Nrx, Nymox, Oncternal, Paxmedica, Pfizer, Tenaya, Valneva, Viiv. Read More
