Individual liberty and choice vs. wider public health became one predictable hinge upon which swung the often-acerbic debates at the CDC’s Advisory Committee for Immunization Practices (ACIP) meeting, which took up – again – the matter of hepatitis B virus (HBV) vaccine scheduling, a day after the panel voted not to vote on such guidance. Read More
After a more than 13-year period of stability with Janet Woodcock as the head of CDER, with Patrizia Cavazzoni taking charge during the next four years of former U.S. President Joe Biden’s tenure, the FDA division has had no fewer than five different people in charge throughout 2025. Up to bat now as acting director is Tracy Beth Høeg, a physician and epidemiologist who co-authored a paper in 2022 with CBER Director Vinay Prasad, FDA Commissioner Marty Makary and others demonstrating that COVID-19 boosters and college vaccine mandates were harmful to young men due to myocarditis risks. Read More
Crescent Biopharma Inc. teamed with Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. to generate “parallel” data of its PD-1/VEGF bispecific antibody, CR-001. The goal is to get 2027 readouts of the bispecific as a monotherapy and as a combination therapy with antibody-drug conjugates in both the U.S. and China. Read More
Positive efficacy results led to Praxis Precision Medicines Inc.’s phase II Embold study in developmental and epileptic encephalopathies (DEEs) being halted early, propelling the company’s shares dramatically upward. Read More
Kazia Therapeutics Ltd. raised AU$50 million (US$33.15 million) in a private placement of equity securities to advance lead candidate paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor in clinical trials for brain cancer and advanced breast cancer. Read More
The first phase of the U.K. synthetic human genome project has successfully completed, realizing key steps in chromosome synthesis. The work has demonstrated a multistep method for transfecting mouse stem cells with native human chromosomes, where they are stably maintained and can be manipulated to replace native DNA with synthetic DNA. The engineered chromosomes can then be transferred into a human cell in place of the native chromosomes. Read More
Biopharma financing activity from January through November reveals an environment that has cycled through dramatic peaks and subsequent normalization. In November 2025, $9.94 billion was collected through 96 transactions, down in both value and volume from $13.23 billion from 137 transactions in October. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Alexion, Alzinova, Atossa, Astrazeneca, Formycon, Jyong, MS Pharma, Neurimmune, Orano, Propanc, Replicate, Roche, Sichuan Kelun, Vycellix. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: J&D, Eli Lilly, Merakris, Uniqure. Read More
