As part of a U.S. FDA evaluation of confirmatory trials for anti-PD-1/PD-L1 antibodies, the agency’s Oncologic Drugs Advisory Committee (ODAC) is being asked this week to consider whether three blockbuster biologics should continue to be available for certain cancer indications for which they received accelerated approval. At question is whether the data from the confirmatory trials for the Roche Group’s Tecentriq (atezolizumab), Merck & Co. Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Co.’s Opdivo (nivolumab) has proved sufficient benefit in particular indications and, if not, whether alternative or ongoing trials could do so. Read More
One of the keys to making a schizophrenia drug work is reducing the side effects, which, if they are powerful enough, will often cause patients to cease the treatment. Laxminarayan Bhat, Reviva Pharmaceuticals Holdings Inc.’s CEO, told BioWorld that new phase II data of the company’s lead candidate shows the drop-out rate was low compared to other schizophrenia drugs. Read More
Respiratory syncytial virus, which puts millions of otherwise healthy infants in the hospital each year, could soon face a new foe. Top-line results from a phase III test of the extended half-life monoclonal antibody nirsevimab, developed by Astrazeneca plc and Sanofi SA, found it reduced lower respiratory tract infections requiring medical attention due to the virus in both healthy preterm and term infants. Read More
A collaboration aimed at identifying and developing potential new antimalarial drug candidate drugs has been announced between Walter and Eliza Hall Institute for Medical Research in Melbourne, Australia, and Janssen Pharmaceutica, with assistance from Johnson & Johnson Innovation. The collaboration has already discovered promising compounds with antimalarial activity from among 80,000 drug-like molecules in the Janssen Jumpstarter Compound Library, a collection of drug-like compounds designed to fast-track discovery of new medicines. Read More
HONG KONG – Pharmcadd Co. Ltd., a developer of an artificial intelligence (AI) and physics-based drug discovery platform, bagged ₩17.3 billion (US$15.5 million) in its series B funding. This brings the total funds raised since its establishment to $22 million. Read More
New hires and promotions in the biopharma industry, including: Aikido, Akero, Antares, Chimerix, Cyclerion, Evgen, Fountain, GT, Himalaya, Orasis, Ryvu, Shoreline. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amydis, Astrazeneca, Axsome, Chugai, Crispr, Cstone, Glenmark, J&J, Karyopharm, Merck & Co., Neoleukin, Scopus, Tarsier, Uniqure, Vertex, Voyager. Read More
