Legislators in Washington again are considering a pair of bills that would affect how patents are obtained and sustained including the Patent Eligibility Restoration Act of 2025. This would constitute a big win for companies in the life sciences thanks to provisions that clarify just what is and is not eligible for patent protection.
In a throwback to the Obama administration, U.S. President Donald Trump signed an executive order pausing federally funded research using infectious pathogens and toxins that may pose a danger until a safer, more enforceable and transparent policy governing such research can be developed and implemented.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Grin, Italfarmaco, Opus.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aché, Alchemab, Bavarian, Biomea, Eli Lilly, Firstgene, Hovione, Lipocine, Mersana, Sitryx, Xlife Sciences.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actuate, Aldeyra, Cantargia, Celldex, Ferring, OSE, Redx, Tharimmune, Thetis, Tiziana, Topas.
With positive phase IIa cardiovascular disease results in hand, Marea Therapeutics Inc. said it is ready to move on to a phase IIb study sometime in the second quarter of 2025. MAR-001, a monoclonal antibody targeting the protein coding gene ANGPTL4, produced an up to a 52.5% placebo-adjusted mean reduction in remnant cholesterol and up to a 52.7% placebo-adjusted mean reduction in triglycerides at 12 weeks.
Theriva Biologics Inc.’s stroma-targeting oncolytic virus approach yielded positive findings in metastatic pancreatic ductal adenocarcinoma, with the top-line readout of phase IIb data showing VCN-01 (zabilugene almadenorepvec) in combination with chemotherapy bested chemotherapy alone on primary and secondary endpoints, which included overall survival.
South Korean government and biopharmaceutical industry representatives urged American policymakers May 7 to refrain from imposing tariffs on pharmaceutical imports, and to spare allies if pharma tariffs are deemed necessary. Both Korea’s Ministry of Health and Welfare on May 4 and the Korea Biotechnology Industry Organization on May 6 submitted comments to the U.S. Department of Commerce in response to its ongoing investigation of pharmaceutical imports.