In a global deal worth up to $770.5 million in up-front and milestone payments, Stevenage, U.K.-based Autifony Therapeutics Ltd. signed with Dublin-based Jazz Pharmaceuticals plc for two ion channel-targeting programs aimed at finding and developing new drugs for neurological disorders. Autifony will take selected candidates through preclinical development, while Jazz will cover clinical development, manufacturing, regulatory activities and commercialization. Read More
Eyebiotech Ltd. doubled the size of its series A round, raising $130 million to advance a pair of assets, with a phase Ib/IIa trial dubbed Amarone underway testing the drug called Restoret in patients with diabetic macular edema and neovascular, or wet, age-related macular degeneration. Read More
The BioWorld Infectious Disease Index (BIDI) jumped 13.04% at the end of January and has been mostly on a downturn since, echoing trends that BioWorld analysis noted last year. BIDI ended October down 47.98%, lower than the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which were down 12.31% and 0.28%, respectively. Read More
Bayer AG said it will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market after a confirmatory trial required by the FDA failed to meet the primary endpoint of progression-free survival vs. standard immunochemotherapy in patients with relapsed follicular lymphoma. It marks the latest stumble for PI3K-targeting drugs in the non-Hodgkin’s lymphoma space. Read More
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication. Read More
New hires and promotions in the biopharma industry, including: Assertio, Avicanna, Haemalogix, Nereid, Outlook, Satellos, Senisca, Tevard, Zura. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amarin, Anthos, Bayer, Biosplice, Bridgebio, Lexicon, Longeveron, Novo Nordisk, Valneva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Novo Nordisk, Alaunos, Absci, Almirall, Amydis, Centogene, Galera, Merck, Qsam, Qu Biologics, Telix, Theseus, Trex Bio. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Aurinia, Boehringer, GSK, Mediwound, Sellas, Tenax. Read More