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. “It creates confusion. And confusion and ambiguity is not good in any respect,” David Dodd, president and CEO of Geovax Labs Inc., told BioWorld. It’s particularly troubling when companies have to decide where to allocate limited R&D dollars, he said. Meanwhile, a federal judge cleared the way yesterday for several medical groups to continue with their court challenge to Kennedy’s vaccine changes and his reconstitution of the CDC’s Advisory Committee for Immunization Practices. If that challenge is successful, all vaccine recommendations made by Kennedy’s hand-picked committee could be overturned.

Amgen swoops on European science in two deals worth up to $1.46B

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. At a time when peer companies are looking for mature programs to head off the impending patents cliff, both deals exemplify Amgen’s strategy of growing its portfolio by investing early in programs involving novel targets. Dark Blue CEO Alastair MacKinnon and Disco CEO Mark Manfredi spoke with BioWorld about their respective deals, both of which validate their efforts.

Monte Rosa jumps on positive phase I data with cardio drug

Shares of Monte Rosa Therapeutics Inc. (NASDAQ:GLUE) were trading at $24.49, up $8.48, or almost 53%, on positive interim data from the 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. Rapid, deep, and sustained degradation of NEK7 turned up in peripheral blood T cells (about 80-90%) in the single ascending dose, multiple ascending dose, and part 3 cohorts across all dose levels. Boston-based Monte Rosa said the compound could “transform” the treatment of atherosclerotic cardiovascular (CV) disease as well as other CV and cardiometabolic illnesses.

Bepirovirsen hits functional cure endpoint in hepatitis B trials

Full data will read out later, but GSK plc anticipates regulatory filings this quarter seeking approval of bepirovirsen, an antisense oligonucleotide therapy, in chronic hepatitis B (CHB) after both pivotal phase III studies hit the primary endpoint of functional cure rate. Bepirovirsen, licensed from Ionis Pharmaceuticals Inc., marks the most advanced oligonucleotide approach in development for CHB, for which the existing standard of care, nucleoside/nucleotide analogues, typically involves lifelong treatment and offers low functional cure rates. If approved, GSK and Ionis have pointed to bepirovirsen’s potential to become the first “finite, six-month therapeutic option” for a disease estimated to affect more than 250 million people worldwide.

South Korea enacts world’s first regulation on synthetic biology

South Korea will implement a new regulation on synthetic biology in April 2026, aiming to foster innovations across both biotechnology and biomanufacturing. On April 2, 2025, the National Assembly enacted the Synthetic Biology Promotion Act as the world’s first legislation dedicated to synthetic biology. With the Cabinet’s approval and promulgation on April 22, 2025, the legislation will be effective after a one-year grace period on April 22, 2026. Synthetic biology, defined as the application of engineering technologies such as genetic assembly, cell culture and genetic engineering has grown in strategic importance globally. Major countries, including the U.S. and China, have launched strategic initiatives, such as the U.S. executive order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy and China’s 14th Five-Year Plan for Bioeconomy Development. The legislation is expected to establish a national R&D ecosystem.

BioWorld 2025 Year in Review

BioWorld looks back at the year’s biggest news. Find all of our 2025 Year in Review articles here.

Also in the news

Aclaris, Actuate, Alloy, Alumis, Alvotech, Apogee, Arrowhead, Artbio, Astrazeneca, Atsena, Biolojic, Boehringer Ingelheim, Bostongene, Bright Minds, Cartography, Cognition, Compass, Convergent, Day One, Demerx, Encellin, Factor, Fractyl, Galapagos, Galecto, Gasherbrum, Genentech, Gilead, Huyabio, IGC, Idorsia, Iksuda, Immuneonco, Instil, Johnson & Johnson, LB, Lineage Cell, Mersana, Metavia, Mezzion, Nanjing Delova, Nanology, Northstar Medical Radioisotopes, Novabridge, Onconano, Outlook, Pfizer, Remix, Repligen, Seres, Splicebio, Spyglass, Syncromune, Variant

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