The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews.
In January 2025, BioWorld tracked 171 phase I-III clinical trial updates, down from 212 in December. The month delivered 12 successful phase III outcomes, six of those in cancer, while two trials ended in failure.
Antibody-drug conjugate developer Duality Biotherapeutics Inc. is gearing up for a second IPO attempt this year, having filed on Feb. 27 a new prospectus on the Hong Kong Stock Exchange. Two other biotechs – Genuine Biotech Ltd. and Cloudbreak Pharma Inc. – also are having another go at a listing in Hong Kong in 2025.
After Study 1’s independent data monitoring committee said the experiment will likely fall short of its primary endpoint with ulixacaltamide in essential tremor, Praxis Precision Medicines Inc. plans to wait for full data from Study 1 as well as Study 2 in the Essential 3 phase III program before deciding on regulatory moves.
The EMA’s Committee for Medicinal products for Human Use (CHMP) is standing by its opinion on Leqembi (lecanemab) after the European .mission pushed back against a recommendation in November 2024 that the Alzheimer’s disease drug be approved
About 17 months after emerging from stealth with its Trueglue discovery platform, Magnet Biomedicine Inc. has joined with Eli Lilly and Co. to discover, develop and commercialize molecular glue therapeutics for oncology. “It’s a really important deal, especially given the discovery of Trueglues is something Magnet is pioneering,” CEO Brian Safina told BioWorld. The deal includes $40 million in up-front and near-term payments, including an equity investment, as well as potential milestone payments, bringing the deal total to more than $1.25 billion, plus tiered royalties.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adicet, Ocugen, Sobi.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosymetrics, Epimab, Eli Lilly, Hansoh, Ligand, Medigene, Renovaro, Schrödinger, Silence, Verve, Vertex, Zerve.
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