The Biden administration’s rollout of a COVID-19 booster plan before the FDA has even approved a booster admittedly is a “judgment call,” U.S. health officials acknowledged Aug. 18. But rather than a judgment call, “the introduction of booster doses should be evidence-driven and targeted to the population groups in greatest need,” the World Health Organization advised in an interim statement issued a week before the White House COVID-19 Response Team’s announcement. Read More
Coherus Biosciences Inc. and partner Shanghai Junshi Biosciences Co. Ltd. continued to build their case for the anti-PD-1 antibody toripalimab, popping the lid off positive interim data from the pivotal, combination phase III study called Choice-01 in first-line advanced squamous or non-squamous non-small-cell lung cancer (NSCLC). Read More
LONDON – Persica Ltd. is poised to take a new pharmaceutical approach to curing chronic lower back pain, after delivering positive data in a phase Ib study of an injectable antibiotic. The development rests on research showing that, as with stomach ulcers, chronic lower back pain is caused by localized bacterial infection. Read More
PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options. Read More
LONDON – The latest data from the large-scale randomized U.K. COVID-19 infection survey confirm vaccines are less effective against the Delta variant of SARS-CoV-2 that is now dominant across the U.S., Europe and elsewhere in the world. Read More
When SARS-CoV-2 first emerged in 2020, with respiratory symptoms as the most obvious feature of infection, the most obvious comparison was to influenza. COVID-19, of course, was never just another flu. Read More
Visus Therapeutics Inc. has expanded its ophthalmic drug portfolio, in-licensing investigational therapies for glaucoma and age-related macular degeneration from Cella Therapeutics LLC, which will be developed by Finland’s Delsitech Ltd. using its extended-release depot technology. Read More
Illumina Inc.’s acquisition of cancer diagnostic specialist Grail Inc. is on go in a $7.1 billion transaction that is structured so that it can be unwound with limited impact on Illumina. However, a number of regulatory entities are closely scrutinizing the deal for a potential regulatory challenge, a fact of life that shaved nearly 10% off the value of the company’s shares in early Aug. 19 trading, and which could ultimately scuttle the transaction altogether. Read More
An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector. Read More
New hires and promotions in the biopharma industry, including: Amo, Avacta, Bluesphere, Kempharm, Metriopharm, Nanoview, Neurophth, Otonomy, Therapeutic Solutions. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alladapt, Coeptis, ICER, Kyan, Lantern, Plus, Vycellix and Vygen-Bio. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Boehringer Ingelheim, Eli Lilly, Index, Kite, Paratek, Senhwa. Read More
