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. Read More
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. Read More
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. Read More
The full rights to Taysha Gene Therapies Inc.’s lead gene therapy candidate are coming back to the company. In 2022, Astellas Pharma Inc. invested $50 million in Taysha for 15% of the company and the exclusive option to license TSHA-102 for treating the rare disease Rett syndrome. That option has expired, according to Taysha. Read More
Caught between the rock and the hard place of most-favored nation (MFN) pricing and the threat of a hefty biopharma sector tariff, drug companies marketing in the U.S. are exploring their options. Several large firms already have committed millions and billions of dollars in investment in new or expanded U.S.-based manufacturing facilities to avoid tariffs on finished drugs. Read More
BioWorld Staff Writer Tamra Sami says it’s impossible to talk about changes to the biotech and med-tech landscape in Asia without discussing China, which is eclipsing the region. In the last two decades, China has shifted from imitator to innovator. Read More
Clinical updates, including data readouts and publications: Aicuris Anti-infective Cures, Aptose, Aqilion, Johnson & Johnson, Ketabon, Merck, Novartis, Praxis Precision, Remegen, Vor. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Actor, Aculys, Delix, Evoq, Formycon, Jacobio, Jacoray, Klinge, Megalabs, Sanofi, Viatris. Read More
