Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE. Read More
An anticancer approach that leads to improved tumor visibility edged closer to the clinic after Grey Wolf Therapeutics Ltd. scooped $49 million in a series B round. The Oxford, U.K.-based immuno-oncology company plans to use the proceeds to move its lead candidate, GRWD-5769, into a phase I/II trial. Read More
Low enrollment in a phase III trial and a missed primary endpoint sent Aridis Pharmaceuticals Inc.’s shares tumbling by 35% on Jan. 26, although the company’s AR-301 (tosatoxumab) showed superior efficacy over the control group in Staphylococcus aureus ventilator-associated pneumonia (VAP) patients. Read More
Ocuphire Pharma Inc. is marching ahead despite falling short of the primary endpoint in top-line data from the Zeta-1 phase II study testing oral APX-3330 in diabetic retinopathy (DR). The trial did not achieve its goal with regard to the percentage of patients with a ≥2-step improvement in Diabetic Retinopathy Severity Score at week 24 in the study eye. Ocuphire plans to schedule an end-of-phase II meeting with the U.S. FDA to review the results. Read More
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022. Read More
China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akeso, Astellas, Cytomx, Denali Capital, Denali Therapeutics, Evotec, Genkore, J&J, Janssen, Lobe, Longevity, Nogra, Sanofi, Summit, Torii. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alk-Abello, Cidara, Fabre-Kramer, Immuron, Inhibikase, Oncotelic, Poxel, Tango. Read More
