The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents. Read More
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib. Read More
Science ministers from 13 countries in Europe are calling on the European Union to offer a home to researchers affected by the Trump Administration’s cuts. They have written to EU research and innovation commissioner Ekaterina Zaharieva asking her to organize a welcome “for brilliant talents from abroad who might suffer from research interference and ill-motivated and brutal funding cuts.” Read More
The U.S. FDA approved 16 drugs in February, up from 12 in January but still falling short of the 2024 monthly average of 19 approvals. Just two of those were new molecular entities (NMEs), continuing a slower pace compared to the year’s average of slightly more than four NMEs per month. Read More
After finishing 2024 with a 15.25% decline, the BioWorld Drug Developers Index rebounded 6.93% in January, only to fall back to a modest 1.06% gain by the end of February. The Nasdaq Biotechnology Index and the Dow Jones Industrial Average followed a similar pattern, each rising about 5% by the end of January, before closing February at 3.13% and -2.48%, respectively. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Briacell, Corvus, Hyloris, Medera, Monte Rosa, Neurocrine, PTC. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech, Candel, Domain, Evofem, Idea, Optinose, Paratek, Windtree, Xbrane. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioinvent, Hikma, Longeveron, Plus, Rhythm. Read More
