CEO David Epstein said Black Diamond Therapeutics Inc. was “delighted” with phase I data testing BDTX-189 in advanced solid tumors harboring EGFR or HER2 alterations, but Wall Street seemed less so. Shares (NASDAQ:BDTX) closed at $13.93, down $8.30, or 37%. Read More
DUBLIN – Numab Therapeutics AG has moved closer to the front rank of European antibody developers by raising CHF100 million (US$111 million) in a series C financing round to accelerate the development of NM21-1480, a trispecific antibody that acts both as a PD-L1 inhibitor and 4-1BB (CD137) agonist. It also contains a human serum albumin recognition group, to extend its circulatory half-life. Read More
Where Ilaris (canakinumab) failed, can Kineret (anakinra) succeed? Swedish Orphan Biovitrum AB is reporting that an investigator-initiated phase III study of its interleukin-1 (IL-1) blocker, Kineret, in 594 hospitalized COVID-19 patients with moderate or severe pneumonia, who had a poor prognosis, uncovered what appear to be dramatic benefits. Read More
LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of either Astrazeneca plc or Pfizer Inc./Biontech SE’s COVID-19 vaccines. Read More
As infections and deaths continue to surge in some countries so does the demand for unfettered access to the technologies behind COVID-19 vaccines and other medical products. In seeking that access, several countries are stressing the need to develop their own manufacturing capacity as they look beyond the current pandemic. Read More
The tech sector's high profile march into life sciences, from Alphabet Inc.'s Verily to IBM Corp.'s Watson, hasn't always been smooth. Successes, such as Exscientia Ltd. and Benevolentai Ltd., have almost universally emerged from within the biopharma sector rather than without. Now Palantir Technologies Inc., a data analysis specialist known best for its counterterrorism and defense work, is looking to bridge the gap with an artificial intelligence platform it is billing as an "operating system" for health care and other companies. Read More
With the advent of targeted therapies, cancer drugs have made strides in safety as well as efficacy. Still, because of the life threatening nature of the illness, safety is less of a focus in cancer drugs than other therapy types. Read More
In their latest submission to Science, Weifeng Shi, director and professor at the Institute of Pathogen Biology at Shandong First Medical University in China, and George Gao, head of Chinese Center for Disease Control and Prevention, have warned that “the global spread of H5N8 avian influenza viruses is a public health concern.” Read More
Anixa Biosciences Inc. and the Moffitt Cancer Center now have details the FDA said it needs regarding their CAR T therapy development program. The collaborators said the information can be provided to the FDA in about 30 days. The agency then has 30 days to respond. Read More
Claiming that convicted felon Martin Shkreli continues to exert control over Vyera Pharmaceuticals LLC from prison, the U.S. Federal Trade Commission (FTC) is seeking sanctions against the former hedge fund manager for intentionally destroying text and WhatsApp messages on his company-issued phone and a contraband phone years after he was instructed to preserve all documents potentially relevant to an ongoing antitrust investigation and litigation. Read More
New hires and promotions in the biopharma industry, including: Alkermes, Atea, Biovaxys, Celularity, Cincor, Cumberland, Cybrexa, Humacyte, MJFF, Mind Cure Health, Neubase, Omega, Pharmather, Rain, Rezolute, Shuttle, Voyager. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelrx, Annovis, Astellas, Black Diamond, Cantargia, Crescendo, Laurent, Merck, Obseva, Pyramid, Recardio, Seagen, Sensei, Transcenta, Xalud. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altavant , Arecor, Biontech, Biopharmics, Codagenix, Eli Lilly, Eurocine, Immunome, Immunoprecise, Lundbeck, Optibrium, Pfizer, Univercells, Verantos, Y-Mabs. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anixa, Everest, Gamadelta, Kintor, Mindmed, Newron, Omeros, Propella, RDIF, Sorrento, Tenaya. Read More
