South Korea will implement a new regulation on synthetic biology in April 2026, aiming to foster innovations across both biotechnology and biomanufacturing.
Confirmed news of Eli Lilly and Co. purchasing Ventyx Biosciences Inc. for $14 per share arrived within a day of swirling rumors that drove shares of the San Diego-based biopharma company up by more than 52% at one point on Jan. 7.
As widely expected, GSK plc and Ionis Pharmaceuticals Inc. reported positive findings from two pivotal trials testing bepirovirsen in chronic hepatitis B, showing the antisense oligonucleotide therapy achieved a statistically and clinically meaningful functional cure rate, indicating a potential transition in CHB treatment beyond the current viral suppression-focused standard of care.
Monte Rosa Therapeutics Inc. followed up December’s positive prostate cancer data with strong interim findings from a phase I study with MRT-8102, a NEK7-directed molecular glue degrader in the works for inflammatory conditions driven by the NLRP3 inflammasome, IL-1, and IL-6.
Amgen Inc. has swooped on two European cancer specialists, buying Dark Blue Therapeutics Ltd. for up to $840 million plus royalties, and sealing a $618 million license agreement with Disco Pharmaceuticals GmbH for rights to a novel cancer cell surface target.
The chaos Health and Human Services Secretary Robert Kennedy has injected into the U.S. vaccine market could have long-term consequences as vaccine makers reevaluate business decisions and pipelines.
Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Altimmune, GH Research, GSK, Humacyte, Idorsia, Kelun-Biotech, Maplight, Moderna, Protagonist, Sanofi, Scinopharm, Takeda.
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