Had it been asked to, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee would have voted Oct. 31 to recommend approval of Vertex Pharmaceutical Inc. and Crispr Therapeutics AG’s exagamglogene autotemcel, or exa-cel, as a one-time transformative treatment for severe sickle cell disease in individuals 12 and older. Read More
Astrazeneca plc is making a $220 million equity investment and tossing in $25 million up front to Cellectis SA as part of a new collaboration agreement. The deal is part of Astrazeneca’s efforts, including a July licensing agreement worth about $1 billion with Pfizer Inc., to delve deeper into gene therapy for treating cancer and rare diseases. Read More
Gate Bioscience Inc., a new(ish) company with a new class of drugs in the works, emerged from stealth mode and disclosed a $60 million series A financing led by Versant Ventures and A16z Bio + Health. Arch Venture Partners and GV took part in the financing as well. Read More
The BioWorld Cancer Index (BCI) saw its highest point of the year from April through July, when it had a run above 30%, before falling to 23.5% at the end of August. It closed Q3 up 22.96% for the year, a sharp divergence from the more extensive Nasdaq Biotechnology Index and Dow Jones Industrial Average, which are tracking down 6.16% and up 1.09%, respectively. Read More
Israel’s finance ministry has increased the amount of funding high-tech companies with a short runway, including biotechs, can apply for under a fast-track scheme run by independent, publicly funded agency The Israel Innovation Authority, in response to the country’s war against Hamas. The program has been boosted by an extra ₪300 million (US$74.7 million), bringing the total budget to about ₪400 million, and from this month will assess applications from startups facing financial difficulties. Read More
Israeli biotech Biolinerx Ltd. will hand off the rights to its stem cell mobilizer, motixafortide, in Asia to China’s Gloria Biosciences Co. Ltd. via an out-licensing deal worth up to $280 million, news that sent stocks soaring nearly 13% on Oct. 31. Read More
Australia has a lot to celebrate when it comes to vaccines. The University of Queensland is where Ian Frazer invented the human papillomavirus vaccine Gardasil, and now Australia is projected to be the first in the word to eliminate cervical cancer, Queensland Deputy Premier Steven Miles said during the Ausbiotech 2023 conference held Nov. 1-3 in Brisbane, Australia. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3Sbio, Abbvie, Aileron, Aldeyra, Apnimed, Atara, Cstone, Eli Lilly, Engene, Forbion, Generate, Inhalon, Kyverna, Ligand, Lung, Mei, Pierre Fabre, Reneo, Selecta, Shionogi, Sitryx, Sobi, Tolerance, Vtv. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biora, Cessation, Chimeric, Cocrystal, Galera, Huidagene, Ionctura, Mersana, Sosei, Sparx, X4. Read More