Another drug from the emerging menin inhibitor drug class has hit safety issues, after the FDA put an early stage acute myeloid leukemia trial of Kura Oncology Inc.’s KO-539 on partial clinical hold because of a patient death. The news from Kura follows safety issues that emerged from Syndax Pharmaceuticals Inc.’s rival SNDX-5613, where an issue with QT prolongation emerged in at least 5% of patients in otherwise encouraging phase I/II trial results announced in April. Read More
What one analyst called “the single most important” nucleoside reverse transcriptase inhibitor in development – Merck & Co. Inc.’s islatravir – has met rocky terrain, with the firm and its partner, Gilead Sciences Inc., pausing combo trials. Read More
It’s decision time for oral drugs that could help the world return to normal even in the midst of the COVID-19 pandemic. The U.K. already has granted emergency authorization to Merck & Co. Inc. and Ridgeback Biotherapeutics Inc.’s antiviral, Lagevrio (molnupiravir), and the EMA is expected to complete its evaluation of the oral drug within the next few weeks. In the U.S., the FDA could announce its decision on Lagevrio shortly after its Antimicrobial Drugs Advisory Committee weighs in Nov. 30 on emergency use authorization. Read More
Bright Peak Therapeutics Inc. has licensed rights to use Livzon Mabpharm Inc.’s anti-PD-1 candidate, LZM-009, to develop its own PD-1 targeted immunocytokines (PD-1 ICs). Bertolt Kreft, chief scientific officer for Bright Peak, told BioWorld that Livzon’s phase II anti-PD-1 “exhibits a promising initial safety and efficacy profile, making it well-suited to the task. Read More
“I was not always someone who would have advertised probiotics,” Michael Otto told BioWorld. And it’s easy to see why. At this point, probiotics are more often dubious wellness offerings than evidence-based therapeutics. Part of the issue is that the mechanisms by which probiotics are supposed to exert their effects are mostly vague. Molecular mechanisms that could account for claimed health benefits are few and far between. But Otto, who is chief of the pathogen molecular genetics section at the National Institutes of Allergy and Infectious Disease, and his colleagues have identified one such molecular mechanism. Read More
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity. Read More
Emergent Biosolutions Inc.’s Bayview facility in Baltimore passed its manufacturing inspection with international regulators, clearing the way for shipment of batches of Johnson & Johnson’s (J&J) COVID-19 vaccine containing drug substance made at the plant. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aptevo, Dnatrix, Galapagos, Ocuphire, Oncotelic, Oramed, Santhera, Scynexis, Transgene. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aligos, Astrocyte, Bluebird, Curative, Dragonfly, Evrys, Kancera, Marvel, Merck & Co., Qurient, Sellas, Simcere, Tonix, Vipergen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aadi, AB, Amryt, BMS, Gilead, Janssen, Neonmind, RDIF, Revive, Seqirus, Sterna, Tonix. Read More
