Phathom Pharmaceuticals Inc. will begin marketing Voquezna (vonoprazan) in December, thanks to the Nov. 1 approval by U.S. regulators, who cleared the potassium-competitive acid blocker at 10-mg and 20-mg doses for all grades of erosive gastroesophageal reflux disease (GERD), maintenance of healing of all grades of the condition and relief of associated heartburn. Read More
Among the avalanche of abstracts for the upcoming American Society of Hematology (ASH) annual conference released early on Nov. 2 were data from Arcellx Inc.’s phase I study of CART-ddBCMA in patients with relapsed or refractory multiple myeloma. The results caught investors’ attention as the company’s stock (NASDAQ:ACLX) jumped 18.5% upward to close at $40.77 per share. Read More
Instead of the two-step process that’s been the typical path for interchangeables in the U.S., Amgen Inc.’s Wezlana got a green light Oct. 31 from the FDA as both the first approved biosimilar and interchangeable to Johnson & Johnson’s inflammatory disease drug, Stelara (ustekinumab). Read More
As a follow-up to the Biden administration’s executive order for artificial intelligence (AI), the U.S. Office of Management and Budget (OMB) has promulgated a memorandum directing federal government agency use of AI. Read More
What’s it going to take for Australia’s biotech industry to be more self-sufficient? Although Australia is far away from the rest of the world, no one is an island when it comes to biotechnology, Ausbiotech CEO Lorraine Chiroiu said during the Ausbiotech 2023 conference held in Brisbane Nov. 1-3. Investors gathered to riff about what they were looking for in Australian biotech investments and what needs to change for the sector to be sustainable. All agreed that the science in Australia is top-notch but that the ecosystem needs more investment to be competitive. Read More
Biopharmas raising money in public or private financings, including: Aileron, Cara, Impact, Memo, Nanobiotix, Projenx, Terremoto, Tryp, Vyne. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Bayer, Blue Water, Globestar, Jaguar, J&J, Locanabio, Kura, Mirati, Prelude, Protagonist, Quadri, Rani, Sangamo, Siren, Smi, Theriva, Tonix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, DBV, Hibio, Merck & Co., Novartis, Novavax, Ocular. Read More
