With Alnylam Pharmaceuticals Inc.’s FDA clearance for Amvuttra (vutrisiran) in the rearview mirror, investors are looking ahead to potentially label-widening phase III data related to another, already approved drug: Onpattro (patisiran). Read More
Up to now, the Pfizer Inc.-Biontech SE COVID-19 vaccine has had a lock on the U.S. pediatric market, for ages 5 to 17, but that could change as early as next week. Read More
Eli Lilly and Co. crossed the line in front of three strong competitors with the U.S. FDA’s approval of Olumiant (baricitinib) as a first-in-disease systemic treatment for severe alopecia areata. Two of those three are, like Olumiant, JAK inhibitors and have recent phase III data to run by the FDA. Read More
Tilt Biotherapeutics Ltd. has closed a €10 million (US$10.7 million) round, enabling it to start two phase II trials of its armed oncolytic virus, TILT-123, in combination with checkpoint inhibitor drugs. Read More
Shanghai Henlius Biotech Inc. signed an exclusive licensing deal with Organon LLC under which Organon will in-license rights for two of Henlius’ internally developed biosimilar candidates for global commercialization, excluding China, Hong Kong, Macau and Taiwan. Read More
U.S. FDA Commissioner Robert Califf offered the keynote address at this year’s annual meeting of the Food and Drug Law Institute (FDLI), revisiting recent events that have roiled the agency’s staff and reputation. Califf made a point of emphasizing the need for new statutory authorities in connection with the supply chains for FDA-regulated products, and remarked that his return to the agency will not be a reversion to the norm in this context. Read More
The European Commission and the U.S. Department of Health and Human Services (HHS) recently signed an arrangement to strengthen their cooperation on preparedness and response to public health threats. Read More
New hires and promotions in the biopharma industry, including: Anjarium, Clearside, Hepion, Immodulon, Iovance, Neuron23, Rubedo Life Sciences. Read More
New and updated preclinical and clinical data presented by biopharma firms at the European Hematology Association Congress, including: Abbvie, Affimed, Agios, Ascentage, Canbridge, Crispr, Daiichi, Disc, Genmab, Iaso, Innovent, Mustang, Novartis, Vertex, XNK. Read More
New and updated preclinical and clinical data presented by biopharma firms at the Endocrine Society annual conference, including: Astellas, Bridgebio, Eiger, Horizon, Innovent, Neurocrine, Novo, Orphagen, Rhythm, Versanis. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Atyr, AVM, Bavarian, Orion, Sarepta, Sirona, Umoja, Valneva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Amivas, Amylyx, Beigene, Bluebird, Guerbet, Homology, Ionis, Mallinckrodt, Merck & Co., Novavax, Nrx, Relief, Veralox. Read More
