Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adcentrx, Atsena, Connect, Eli Lilly, Iaso, Simcere, Trethera.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Eledon, Iambic, Jasper, Lupin, Novartis, Qanatpharma, Revolution Medicines, Sernova, Sironax, Zentiva.
Historically, Q2 has often been one of the strongest quarters for biopharma financing, but 2025’s figures suggest a more cautious investment climate. Biopharma companies raised $16.02 billion in the second quarter (Q2) of 2025, a modest increase from the $13.11 billion brought during Q1. While the uptick signals some recovery from Q1, the sector is still pacing well behind the highs of recent years.
Nuclidium AG is poised to circumvent the complex production and supply issues that have held back access to radiopharmaceuticals after closing a CHF79 million (US$99.3 million) series B, to advance the clinical development of its copper isotopes and extend the global manufacturing network.
Ultragenyx Pharmaceutical Inc. and Mereo Biopharma Group plc, along with investors, had hoped for an early halt to the phase III study of setrusumab in treating brittle bones. They didn’t get it, as the clinical trial’s data monitoring committee wants the study to roll on through its final analysis.
It’s been more than seven years in coming, but the U.S. FDA is at last making public at least some of the complete response letters (CRLs) it’s sent to drug and biologic sponsors to notify them of deficiencies in their approval applications.