Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Avadel, Formycon, Hutchmed, Innovent, Sydnexis, Telix, Tempest, Vigeneron.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech, Basilea, Casma, Cullinan, Dr. Reddy’s, Genrix, Harmony, Immunoprecise, Lupin, Neurop, Ocugen, Pincell, Pfizer, Scinai, Seyltx.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Corcept, Duality, Immunic, Maia, Novartis, Regenxbio.
Biopharma financings totaled $21.38 billion through May 2025, down sharply from $62.57 billion during the same period in 2024, but roughly in line with levels seen in 2023 and 2022. Biopharma companies raised $5.55 billion in May, more than doubling the $2.4 billion raised in April.
As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner. ATX-101, a configuration of sodium ion channel blocker bupivacaine and a biopolymer, which is in a phase IIb registration study, is designed to offer pain relief following total knee arthroplasty.
The EMA’s safety committee has issued a warning that the GLP-1 receptor agonist Ozempic (semaglutide, Novo Nordisk A/S) can cause an acute eye condition in which the optic nerve is damaged by a sudden loss of blood supply. After reviewing several large epidemiological studies, clinical trial and in-market data, EMA’s Pharmacovigilance Risk Assessment Committee has concluded non-anterior ischemic optic neuropathy is a “very rare” side effect of Ozempic, that “may affect up to one in 10,000 people taking semaglutide.
The BioWorld Biopharmaceutical Index extended its downward trend over April and May, closing the latter month down 6.47% after reaching a peak gain of 9.64% at the end of February. The Nasdaq Biotechnology Index followed a similar trajectory, finishing May with a 5.37% decline. Meanwhile, the Dow Jones Industrial Average dipped through April but rebounded slightly in May, ending the month down 0.64%.
Researchers from the University of Arizona have unveiled that coordinated Y chromosome loss in both cancer cells and immune cells may explain the worse prognosis in people with this alteration. The loss of the Y chromosome (LOY) is one of the most frequent somatic mutations in men, particularly with advancing age. Investigating the mechanisms and effects of LOY in peripheral blood mononuclear cells
and its association with immune and tumor cells, they “found a relationship between the Y chromosome loss in normal cells inside the tumor and the Y chromosome loss inside the cancer cell,” Dan Theodorescu, senior author of the study, told BioWorld.
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