A day after the CDC’s Advisory Committee for Immunization Practices (ACIP) voted not to vote on guidance for scheduling hepatitis B virus (HBV) vaccines, the group is taking up the matter again. Members spent their first hours of the meeting on a renewal of squabbling over language in the two voting questions, and some posited more questions of their own. “Are we vaccinating for a child or for herd immunity?” asked ACIP member Kirk Milhoan, pointing to a “paucity of data” regarding safety and efficacy as the debate continued over benefit vs. harm with HBV shots for newborns or for children at 2 months of age. ACIP voted 8-3 to do away with the universal recommendation for the hepatitis B vaccine at birth. Balloting was 6-4, with one abstention, that parents of older children should consult their physicians about hepatitis B antibody testing before considering further HBV shots.

Høeg appointment as acting CDER director tied to vaccine strategy?

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. RBC Capital Markets analyst Brian Abrahams said Høeg’s appointment “is clearly negative for vaccine makers.” It follows a leaked internal email from Prasad earlier this week laying out a new vaccine approval path.

Crescent in PD-1/VEGF bispecific race with Kelun, raises $185M

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 (ADCs) in both the U.S. and China. According to the two-way deal announced Dec. 4, Kelun gained exclusive rights to research, develop and commercialize CR-001 in mainland China, Hong Kong, Macau and Taiwan for $50 million, including a $20 million up-front payment and up to $30 million in milestone payments, plus tiered low to middle single-digit royalties on net sales of CR-001. Crescent gained exclusive global, ex-China, rights to Kelun’s preclinical integrin beta-6 (ITGB6)-directed ADC candidate, SKB-105 (CR-003), in a $2 billion deal. That included an $80 million up-front payment and up to $1.25 billion in milestone payments.

DEE-lightful: Praxis’ phase II results allow stock to flex its muscle

Positive efficacy results in Praxis Precision Medicines Inc.’s phase II Embold study in developmental and epileptic encephalopathies (DEEs) has been halted early, propelling the company’s shares dramatically upward. Positive results from the registrational cohort of the phase II Embold study of relutrigine (PRAX-562), a sodium channel blocker, for treating patients with SCN2A and SCN8A DEEs led a data safety monitoring committee to make the call after an interim analysis. The company’s stock (NASDAQ:PRAX) had surged 30% at midday, with shares going for $248.50 each.

Kazia raises AU$50M to advance PI3K/mTOR inhibitor paxalisib

Kazia Therapeutics Ltd. raised AU$50 million (US$33.15 million) in a private placement of equity securities (PIPE) to advance lead candidate paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor in clinical trials for brain cancer and advanced breast cancer. The offer consists of AU$50 million of ordinary shares and prefunded warrants priced at $5 per American depositary share (ADS), with each ADS representing 500 ordinary shares. The financing was led by Adar1 Capital Management LLC, Ikarian Capital LLC, Stonepine Capital Management, Velan Capital Investment Management LP and Revach Capital Management LLC. Kazia expects the funding will extend its cash runway into the second half of 2028.

First phase of synthetic human genome project successfully completes

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.

Biopharma funding normalizes as 2025 outperforms post-pandemic lows

Biopharma financing activity from January through November reveals an environment that has cycled through dramatic peaks and subsequent normalization. The sector saw an unprecedented surge during the pandemic-driven investment boom, with totals more than doubling to $122.4 billion in 2020 and remaining high in 2021 at $109.6 billion. Activity cooled considerably in 2022, rebounded in 2023 and 2024, before moderating to $72.1 billion in the first 11 months of 2025.

Also in the news

Alexion, Alzinova, Apellis, Astrazeneca, Atossa, Bioage, Bioarctic, Crescent, Denali, Eli Lilly, Estrella, Etheros, Formycon, Genmab, Hemostemix, Immvira, J&D, Jyong, Merakris, MS Pharma, Neurimmune, Nona, Orano, Pliant, Propanc, Replicate, Roche, Royalty, Scineuro, Sichuan Kelun, Sobi, Sudo, Trevi, Uniqure, Vaxil, Viromissile, Vycellix