Adults with generalized myasthenia gravis (gMG) have yet another therapeutic option, this time from UCB SA, with the U.S. FDA’s approval of orphan drug Rystiggo (rozanolixizumab-noli), a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor. Read More
The dose-escalation portion of Black Diamond Therapeutics Inc.’s phase I study of BDTX-1535 for treating non-small-cell lung cancer (NSCLC) produced strong data that moved the market in a big way. Read More
Less than a week after Eli Lilly and Co.’s $2.4 billion, IL-17-based buyout of Dice Therapeutics Inc., Moonlake Immunotherapeutics Inc. offered more news in the space by way of data from the global phase II trial called Mira evaluating the efficacy and safety of the Nanobody sonelokimab in moderate to severe hidradenitis suppurativa (HS). Read More
Later this year, Mendus AB plans to move its allogeneic cell-based cancer vaccine, vididencel, into a phase II combination trial with oral azacitidine to evaluate the regimen’s potential as a maintenance therapy in patients with acute myeloid leukemia (AML). Read More
Japan’s Ministry of Health, Labour and Welfare approved Taiho Pharmaceutical Co. Ltd.’s Lytgobi (futibatinib) for unresectable biliary tract cancer harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions that has progressed after chemotherapy. Read More
Scientists in the U.K. have reacted with dismay to the announcement that the National Cancer Research Institute (NCRI) is to close, 22 years after it was set up to coordinate the efforts of industry, government research agencies and medical charities that sponsor and fund clinical trials. Read More
After nearly 10 years in clinical development and just a few months after an EMA rejection, Ipsen SA will be making its case June 28 before a U.S. FDA advisory committee for its ultra-rare bone disease drug, palovarotene. Read More
Eubiologics Co. Ltd. said it would file for regulatory approval for its COVID-19 vaccine called Eucorvac-19 in the Philippines, after announcing positive interim phase III trial results on June 27.
New and updated clinical data presented by biopharma firms at the American Diabetes Association's 83rd Scientific Sessions, including: Biomea, Carmot, Eli Lilly, Inversago, Novo, Sernova, Vertex, Zealand. Read More
New and updated clinical data presented by biopharma firms at the European Association for the Study of the Liver Congress, including: 89bio, Arrowhead, Mirum, Takeda, Vir. Read More
Biopharmas raising money in public or private financings, including: Contrafect, Foresee, Galderma, Immunogenesis, Immutep, Kinarus, Moonlake. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Alligator, Avalo, Canbridge, Fibrogen, Freeline, Janssen, Lexicon, Pfizer, Portage, Rallybio, Sanofi, Savara, Sorrento, Takeda. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alx, Invivyd, Pharvaris. Read More
