There was a curate’s egg for Sanofi SA from this month’s meeting of the EMA’s Committee for Medicinal Products for Human Use, with a recommendation to approve one of the French pharma’s drugs – and the rejection of another.
Biopharma companies announced $73.38 billion in deals from 240 transactions during the third quarter (Q3) of 2025, bringing the year-to-date total to $212.44 billion, up from $149.87 billion in the same period of 2024. The total marks the highest deal value through Q3 ever recorded by BioWorld.
The U.S. FDA named the first nine recipients of the recently unveiled commissioner’s national priority voucher (CNPV) program aimed at addressing unmet public health needs by shortening regulatory review times to as little as one to two months. For one of those firms, Disc Medicine Inc., which submitted an NDA for bitopertin for rare genetic disorder erythropoietic protoporphyria in September, that could mean a potential approval before the end of 2025.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Belite, Chiesi, Minovia, Transpire.
Biopharma happenings, including deals and partnerships, and other news in brief: Amphista, Apollomics, BMS, Enveric, Gilgamesh, GSK, Insitro, Scisparc, Scynexis.
Antibody-drug conjugate (ADC) specialist Aimedbio Inc. announced Oct. 16 the signing of a potential $991 million deal with Boehringer Ingelheim GmbH to license out its novel preclinical ADC asset targeting solid tumors, including KRAS mutations, which is set to enter phase I study next year.
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