Positive top-line data from Beyondspring Inc.’s phase III study of plinabulin combined with docetaxel to treat second- and third-line non-small-cell lung cancer (NSCLC) compared to docetaxel alone propelled the company value dramatically higher Aug. 4. Read More
There’s a lot of competition in the regulatory T cells (Tregs) space and that’s a sign that something good is happening. Sonoma Biotherapeutics Inc. CEO Jeff Bluestone likened it to a typical drive leading to an everyday observation. Read More
LONDON – Mestag Therapeutics Ltd. has closed a hefty $45 million seed round to advance development of antibodies targeting activated fibroblasts, in the treatment of cancer and immune diseases. Read More
New top-line results from the phase IIb/III Allegro trial of Pfizer Inc.'s once-daily oral JAK3 inhibitor, ritlecitinib, have met the trial's primary efficacy endpoint of improving scalp hair regrowth in patients with alopecia areata vs. placebo. The new data, to be paired with long-term trial results from Pfizer's long-term Allegro-LT study, move the program one step closer to an expected early 2022 NDA filing. Read More
The U.K.’s National Institute for Health and Care Excellence (NICE) is playing catch-up after seeing its workflow disrupted by the COVID-19 pandemic and has made the first funding approval using a new fast track appraisal process. Read More
Publication this summer of phase II data with Spruce Biosciences Inc.’s CRF1 antagonist, tildacerfont, for classic congenital adrenal hyperplasia (CAH) in the Journal of Clinical Endocrinology and Metabolism (JCEM) highlighted the indication where a handful of players are known to be active. Read More
PERTH, Australia – In a possible world-first decision, an Australian court has ruled that artificial intelligence can be named as the inventor of a patent. Federal Court Justice Jonathan Beach ruled in Thaler v. Commissioner of Patents that under Australian patent law, inventors don’t necessarily have to be human. Read More
For the first time ever, Canada will be granting patent term adjustments beginning in January. That’s welcome news for the biopharmaceutical and med-tech industries, and it’s long overdue, Jeffrey Morton, a partner at Snell & Wilmer LLP, told BioWorld. Read More
Citing a surge in merger filings, the U.S. Federal Trade Commission (FTC) said it is adjusting its process for reviewing mergers, which means more mergers may be reviewed retroactively. Read More
New hires and promotions in the biopharma industry, including: Ancilia, Aro, Cannabics, Fate, Immunoprecise, IMV, In8bio, Onkure, Rarecan, Telix, Theragnostics, T-knife, Vaxil, Vertex. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allegro, Ambrx, Angion, Antibe, Eli Lilly, Evotec, Fate, Jacobio, Janssen, Kiniksa, Lumosa, Lutris, Rhythm, Springworks. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abl, Advita, Aldeyra, Arcturus, Bausch, BMS, CSL, Cytodyn, Marinus, Medexus, Moderna, Monopar, Novartis, Panther, Pharmather, Relief, Roche, UCB. Read More
