Patients with an aggressive form of lymphoma who have failed prior therapies now have a new option for treatment with the U.S. FDA’s accelerated approval of Columvi (glofitamab-gxbm), which was granted under priority review a few weeks ahead of the July 1 PDUFA date. Read More
Clene Inc. plans to sit down in the third quarter of this year with the U.S. FDA for talks about approval for gold nanocrystal suspension CNM-Au8, bolstered by favorable biomarker findings in amyotrophic lateral sclerosis (ALS) from the phase II/III Healey ALS platform trial – along with a sizeable time-to-event and survival data package that should drive the conversation. Read More
After almost 30 years in business, Sangamo Therapeutics Inc. is finally nearing a BLA filing for one of its programs. But the company, wounded by the recent loss of alliances with Biogen Inc. and Novartis AG, is also running out of cash and investor interest – and it badly needs a new deal to stay afloat. Read More
Azitra Inc. made its debut on the public market June 16, in the hopes of raising a relatively modest $7.5 million to enable it to fund clinical trials, manufacturing and R&D, as well as working capital and other general corporate purposes. Read More
The U.S. FDA greenlighted Highfield Biopharmaceuticals Co. Ltd.’s IND, paving way for the Chinese immunotherapy firm to begin clinical testing its immunoliposome cancer therapy. Read More
In its first untitled letter in more than a year, the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) took Xeris Biopharma Holdings Inc. to task for two webpages promoting the company’s Recorlev. Read More
The first five months of the year showed a slight increase in U.S. FDA approvals, though numbers are down compared to the previous four years. Worldwide approvals are down 16.67% through May, but up 5.42% compared to the previous seven years’ average. Read More
The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend COVID-19 vaccines for the 2023-2024 vaccination campaign be monovalent vaccines that target the XBB variants, currently the most prominent variants of the SARS-CoV-2 virus. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Aldeyra, Anokion, Atea, Eloxx, Hepion, Iovance, Neurocrine, Osivax, Pulmatrix, Tonix, Verge, Vyriad. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Beyond Air, Bio-Thera, Biomm, Cantex, Cholesgen, Clearmind, Coherus, Edesa, Flamingo, GSK, Lundbeck, Novartis, Scisparc, Surface, Vtv. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altamira, Anavex, Avenge, Biostar, Glycomimetics, Ipsen, Mabwell, Medexus, Mersana, NS, Seagen, Takeda, UCB. Read More
