Incyte Corp.’s Zynyz (retifanlimab-dlwr) has received another U.S. FDA approval and put some distance between it and a 2021 complete response letter. The FDA gave the humanized monoclonal antibody targeting PD-1 the nod for first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal. That makes it the only approved first-line treatment for this cancer. Read More
The BioWorld Drug Developers Index underperformed both the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA) throughout February and March. However, it showed some recovery by the end of April, finishing the month down 4.67%, slightly worse than the DJIA’s 4.41% decline. The NBI ended April slightly up from both, with a year-to-date drop of 1.16%. Read More
Even before the Trump administration’s executive order wiping out the concept of diversity, equity and inclusion, the statistics on female representation in the biotech industry painted a story of stagnating progress. But for Jane Wall, managing director of the U.K. Bioindustry Association (BIA), the available statistics also begged a question: Where was the U.K. specific data that could inform attempts to change things? There was “much frustration around stats being recycled without context or background – and very little our community could relate to,” Wall said. Read More
Therini Bio raised an additional $39 million in its series A financing round, bringing the total for the round to $75 million. The capital will be used to advance its fibrin-targeting immunotherapies for neurodegenerative diseases. Read More
It’s been a big week for Inozyme Pharma Inc. On the heels of a promising interim readout for phase III-stage enzyme replacement therapy (ERT) candidate INZ-701 in ENPP1 deficiency, the firm agreed to be acquired by Biomarin Pharmaceuticals Inc. in a deal valued at about $270 million, putting the rare disease ERT in the hands of an experienced commercial team. Read More
Gene and cell therapies (GCTs) can target the kidney to treat congenital, acute or chronic diseases affecting this organ. However, its complex structure poses a challenge for these technologies. To be precise and effective in the long term, new approaches should circumvent the specificities of renal tissue, with novel methods of delivery and gene transfer to offer new therapeutic options for patients who lack them. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ADC, Amgen, Eli Lilly, Nanoscope, Novo Nordisk, Regeneron, Sanofi, Telomir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Biocryst, Biohaven, Brainchild, Cabaletta, Cure Rare, Ips, Kaerus, Merck, Mesoblast, Poltreg, Xspray. Read More
