Respiratory syncytial virus (RSV) continues to be a tough indication. Enanta Pharmaceuticals Inc.’s phase IIb study of otherwise healthy adults treated with EDP-938, an N-protein inhibitor, missed its primary endpoint of reduction in total symptom score compared to placebo. It also missed the study’s secondary antiviral endpoints. Read More
Inceptor Bio LLC, a company developing cell therapies for difficult-to-treat cancers, has closed a $37 million series A financing led by Kineticos Ventures, the second fund founded by Inceptor CEO Shailesh Maingi. Altogether, about 40 investors have supported the company's efforts, he told BioWorld. Proceeds from the round, which follows a $26 million seed financing in 2021, will support moving Inceptor's lead CAR T program into phase I testing, a move targeted for the second half of 2023, and continued development of rare CAR-macrophage and CAR-natural killer cell programs. Read More
Shares in Bavarian Nordic A/S jumped after the company received an order of its monkeypox vaccine from an “undisclosed European country.” The order comes amid a small but growing number of cases of monkeypox in Europe, with nine reported in the U.K. and further cases in Portugal and Spain, bringing the total in the continent to more than 20. Read More
Evotec AG and Almirall SA have entered a multitarget drug discovery alliance focused on severe skin disease, from which Evotec could earn up to €230 million (US$243.5 million) in per-program milestones. It is also receiving an undisclosed up-front payment, research funding and, should any products reach the market, it would also bank sales royalties in the high-single-digit percentage range. Read More
Findings from three recent studies are shedding light on the pathways that are activated in severe cases of COVID-19, paving the way for earlier diagnosis and more targeted treatments. Read More
Two days after the U.S. FDA authorized a single booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine for children ages 5 to 11, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave its blessing to the third dose. Read More
Another spate of U.S. FDA guidances for prescription drug manufacturers includes updates for carton labeling, product-specific advice and recommendations on mitigating potential drug shortages. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acasti, Adaptive Phage, Anji, Cabaletta, Epiendo, Immatics, Imugene, Keros, Moderna, Passage. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelrx, Active Biotech, Alnylam, Calliditas, Cansino, Cytovation, Gedea. Read More
