With a PDUFA date less than four weeks away, Urogen Pharma Inc. has been having a rough ride on the Street since the U.S. FDA released a joint briefing document for the May 21 Oncologic Drugs Advisory Committee meeting on UGN-102 (mitomycin).
Frets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s COVID-19 vaccine Nuvaxovid, indicated for adults 65 and over and people 12-64 years old with at least one underlying condition that puts them at risk of severe outcomes from infection by the virus.
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.
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.
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.
A pair of studies published in Diabetologia demonstrate that use of continuous glucose monitors (CGMs) reduces hospitalizations in people with type 1 diabetes and in those with type 2 diabetes who use insulin compared to use of capillary blood glucose monitoring. Abbott Laboratories’s REFLECT real-world studies showed that use of its Freestyle Libre CGMs reduced the severity of cardiovascular conditions associated with diabetes and, consequently, led to fewer in-patient stays.
PhaseV Inc. raised $50 million in a series A funding round to further develop its machine learning (ML) platform which helps companies reduce the cost and duration of clinical trials, and increase their possibility of success.
Royal Philips NV unveiled its Future Health Index report for 2025, and it reveals the widening trust gap between health care professionals and patients concerning the adoption of AI in health care.
The U.S. Centers for Medicare & Medicaid Services reported a request for information for a modernized digital health ecosystem that would presumably improve beneficiary access to digital health technologies.
Rznomics Inc. scored a potential ₩1.9 trillion (US$1.35 billion) global license option agreement with Eli Lilly and Co. to codevelop a novel RNA editing gene therapy to treat hereditary hearing loss.
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