With labeling discussions begun for TG Therapeutics Inc.’s ublituximab to treat relapsing multiple sclerosis, Wall Street was optimistic about the PDUFA date of Dec. 28 assigned to the glycoengineered CD20 monoclonal antibody. Shares of New York-based TG (NASDAQ:TGTX) closed Nov. 11 at $9.34, up 91 cents, or 10.8%, having risen more than 52% over the previous five days. With late-cycle review talks with the U.S. FDA done, ublituximab seemed well on its way. Read More
In August, Pact Pharma Inc. suspended its phase I trial after 16 patients had been treated with its autologous CRISPR-edited T cells “for business reasons,” the company announced at the time. Scientifically, though, the trial broke enough new ground to be concurrently presented in a late-breaking oral session at the 2022 annual meeting of the Society for the Immunotherapy of Cancer (SITC) and published as an accelerated article preview in Nature on Nov. 10, 2022. Read More
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon. Read More
Immutep Ltd.’s lead immunotherapy candidate eftilagimod (IMP-321, efti) met the primary endpoint in its phase II trial evaluating the combination of efti and Merck & Co. Inc.’s Keytruda (pembrolizumab) as first-line treatment of non-small-cell lung cancer (NSCLC), reporting final data that show an overall response rate of 40.4%. Read More
Atriva Therapeutics GmbH, a small firm founded in 2015 to develop a host-targeted antiviral approach for treating respiratory viral infections, seems to have found itself in thick of it. As the U.S. CDC and other health agencies warn of an uptick in respiratory viral infections – the so-called “tripledemic” of influenza, respiratory syncytial virus and COVID-19 – the German company is gearing up to launch a basket trial testing lead candidate zapnometinib in all three indications. Read More
Acting on its new promise to restore “rigorous enforcement” of the U.S. ban on unfair methods of competition, the FTC filed an amicus brief Nov. 10 supporting Avadel CNS Pharmaceuticals LLC’s motion to delist a Jazz Pharmaceuticals Inc. patent from the FDA’s Orange Book. Read More
Viatris Inc.’s chief information officer, Ramkumar Rayapureddy, is facing an SEC insider trading complaint, along with criminal charges brought by the fraud division of the U.S. Department of Justice. Another man, Brian Wong, was charged with illegal trading ahead of Merck & Co. Inc.’s acquisition of Pandion Therapeutics Inc. Read More
Easy access to financing, talent, and connection to sizable potential markets are Hong Kong’s advantages to develop the health care robotics industry, according to speakers at the Asia Summit on Global Health. Read More
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer Annual Meeting including: Apexigen, Aulos, CG, Crispr, Cue, Curevac, Domain, Enterome, Immutep, Invios, Iovance, Medikine, Neoimmunetech. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alpheus, Atom, Biosplice, Cybin, Equillium, Immix, Immunitybio, Inventprise, Janssen, Longeveron, Nanology, Oncosec, Que, Redx, Resolve, Stellas, TME, Unicycive. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Biodesix, Curis, Danaher, Eli Lilly,
EOM, FSD, Harbour Biomed, Immunocore, Kao, Karo, Kirin, Moderna, Nona, Regen, Teva, Xphyto.
