DUBLIN – Shares in AC Immune SA were off more than 40% Sept. 23 on news that its tau-directed antibody, semorinemab, which is partnered with Genentech, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease. Read More
Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee. Read More
As Johnson & Johnson (J&J) made public the launch of a phase III trial with its COVID-19 vaccine, officials from the company and others at the virtual Biopharm America meeting discussed modes of innovation in the pandemic era. Read More
Two studies seek to answer the most pressing question for physicians examining a patient with COVID-19: What's this person's risk of death? Mount Sinai researchers presented their clinical prediction model in The Lancet Digital Health and a team from Johns Hopkins published their risk calculator in the Annals of Internal Medicine. Read More
In the past 10 years, the advances in understanding the etiology of neurodegenerative diseases have been dramatic. “The development of novel biomarkers and other tools as well are key in aiding diagnostic potential and the ability to track disease progression have been phenomenal,” Isaac Veinbergs, CEO of newly created Libra Therapeutics Inc., told BioWorld. Read More
Nutcracker Therapeutics Inc., a startup developing a "push-button GMP-in-a-box" platform to manufacture mRNA therapeutics, has raised $60 million in series B financing led by Arch Venture Partners. Read More
PERTH, Australia – Sydney-based Chimeric Therapeutics Ltd. has acquired exclusive worldwide rights to develop and commercialize the City of Hope Cancer Center’s chlorotoxin chimeric antigen receptor cell therapy that uses a peptide derived from scorpion toxin to direct T cells to target glioblastoma. Read More
HONG KONG – New data from Beigene Ltd. recently presented at the ESMO Virtual Congress 2020 showed its PARP inhibitor pamiparib helped shrink tumors in almost 65% of people with platinum-sensitive ovarian cancer treated with the candidate during a pivotal trial. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Convalescent plasma trials expand; CBD public meeting, generics; ICER updates in CF in MM. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Actinium, Afimmune, Bridge, Clearside, Cytokinetics, Dr. Reddy's, Durect, Enterome, Genentech, J&J, Macrogenics, Morphic, Neximmune, Nicox, Oncimmune, Selecta, Sobi, Takeda, Verona, Vtv. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Cryosystem, Athenex, Athersys, Bluebird, Eagle, GW, Neurorx, Novartis, Pfizer, Sinovac, Symbio. Read More
