After a previous phase III failure, Savara Inc. kept at it and found success with molgramostim for the rare lung disease autoimmune pulmonary alveolar proteinosis. A second attempt, the pivotal phase III Impala-2 study of molgramostim, an inhaled form of recombinant granulocyte macrophage colony-stimulating factor for adults, hit its primary endpoint and left participants breathing easier. The results led Savara to say it would complete a BLA submission sometime in the first half of 2025, with filings in Europe and Japan to follow.
Continuous glucose monitors continue to post positive results for managing diabetes in an ever-expanding population. Long a mainstay of disease management for those with type 1 diabetes, the devices have also proved themselves in treating type 2 diabetes that requires multiple daily injections of insulin.
Takeda Pharmaceutical Co. Ltd. is progressing mezagitamab to phase III trials after the CD38 monoclonal antibody showed rapid and sustained increases in platelet counts in patients with persistent or chronic primary immune thrombocytopenia (ITP) in a phase IIb trial.
Preliminary data show Biotron Ltd.’s lead compound BIT-225 met the primary objectives of the phase II BIT225-011 trial, a longitudinal, open-label trial designed to characterize the effect of the compound added to ongoing, suppressive antiretroviral therapy in HIV-1-infected, treatment-experienced patients who achieved only partial immune reconstitution.
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor and glucagon receptor dual agonist, mazdutide, saw 80% reduction in liver fat content in patients with more than 10% liver fat content in the phase III Glory-1 obesity trial.
Takeda Pharmaceutical Co. Ltd. is progressing mezagitamab to phase III trials after the CD38 monoclonal antibody showed rapid and sustained increases in platelet counts in patients with persistent or chronic primary immune thrombocytopenia (ITP) in a phase IIb trial.
Top-line phase III data from G1 Therapeutics Inc.’s pivotal Preserve 2 study of Cosela (trilaciclib) in treating metastatic triple-negative breast cancer missed its primary endpoint of overall survival, submerging the stock on June 24.
Any skepticism that might have been lingering in the wake of Alnylam Pharmaceuticals Inc.’s February decision to tweak the analysis plan for the Helios-B trial testing vutrisiran in transthyretin amyloidosis with cardiomyopathy appeared to dissipate as the company reported top-line data showing the study met the primary and all secondary endpoints.
Results presented at the American Diabetes Association’s 84th Scientific Sessions in Orlando this weekend demonstrated significant reductions in blood glucose and insulin requirements in people with type 2 diabetes using Insulet Corp.’s Omnipod 5 automated insulin delivery (AID) system, providing a solid base for the company’s expansion into a much larger market.
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