A new study from researchers at the Washington University School of Medicine In St. Louis demonstrated evidence of a long-lasting immune response, possibly one that could last for years, from receiving Pfizer Inc.’s mRNA COVID-19 vaccine. Read More
LONDON – New data have arrived to allay concerns about shortages of COVID-19 vaccines disrupting dosing schedules, and also answering the question of whether third – booster – doses will restore waning immunity and be effective against viral variants. Read More
PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved. Read More
CEO John Leonard said Intellia Therapeutics Inc. plans “to share information on a cohort-by-cohort basis, so we get a consistent readout” and, as the year goes on, longer-term follow-up findings will emerge from the phase I trial with the company’s lead in vivo genome editing candidate, NTLA-2001. Read More
Swiss biotech Polyphor AG is facing an uncertain future after a pivotal phase III study of the company’s balixafortide in HER2-negative breast cancer showed the drug did not improve response rates compared with standard therapy alone. Read More
Top-line data from a phase II trial of Italfarmaco SpA's givinostat in men with Becker muscular dystrophy found it failed to affect a significant change in total muscle fibrosis vs. placebo, the study's primary endpoint. But whether the outcome reflected a shortcoming of the drug or a function of the rare condition's clinical profile remained uncertain, with the company placing its bets on the latter. Read More
Multiple companies are pursuing CD47-blockade as a tumor immunotherapy approach. Sana Biotechnology Inc., too, is interested in the therapeutic potential of CD47 – but from a very different angle. By overexpressing CD47 on stem cells, researchers at Sana want to make transplanted cells invisible to the immune system. Read More
The FDA’s recent release of documents related to its accelerated approval of Aduhelm (aducanumab) did little to reduce the controversy surrounding that decision and the U.S. pricing of Biogen Inc.’s Alzheimer’s drug. Read More
Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. bowed out of an opioid trial set for June 28 in New York by reaching a last-minute settlement with the state. Read More
New hires and promotions in the biopharma industry, including: Amphista, Astrazeneca, Cabaletta, Esperion, Kinnate, Lengo, Moderna, Novartis, Phico, Ribometrix, Ribon. Read More
New and updated preclinical and clinical data presented by biopharma firms at the 81st Scientific Sessions of the American Diabetes Association, including: Astrazeneca, Boehringer, Diabetology, Eiger, Eli Lilly, Novo, Remd, Scohia. Read More
New and updated preclinical and clinical data presented by biopharma firms at The International Liver Congress – The Annual Meeting of the European Association for the Study of the Liver, including: Arbutus, Arrowhead. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Adelia, Amydis, Bellicum, Bioeq, Cannabics, Catalyst, Crescita, Croma-Pharma, Cybin, Dydo, Galderma, Ilias, Immunitybio, Inceptua, Mass General, Medicinova, Oasmia, Orphazyme, Redhill, Sol-Gel, Teva, UNC Lineberger. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Adial, Astellas, Aurinia, Biomarin, BMS, I-Mab, Incyte, Innocare, Jazz, Lynk, Mirati, Morphosys, Nicox, RDIF, Regeneron, Samsung, Y-Mabs. Read More
