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BioWorld - Monday, June 29, 2026
Breaking News: FDA says yes to Viridian’s Lumvoa in TEDBreaking News: Science fiction realized: BCI tech is here
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Tracy Beth Høeg, acting CDER director

Høeg appointment as acting CDER director tied to vaccine strategy?

Dec. 5, 2025
By Karen Carey
No Comments
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.
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Vial and syringe with blue hues

Hippocratic loath? ‘Harm’ threat from ACIP’s proposed HBV shift

Dec. 5, 2025
By Randy Osborne
No Comments
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.
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Biopharma money raised by quarter in 2025 (US$M)

Dec. 5, 2025
Biopharma money raised to-date and by month in 2025, including public, private and other financings.
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ACIP continues to struggle with HBV vaccine scheduling

Dec. 5, 2025
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A preview of the next edition of BioWorld, Dec. 5, 2025
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Illustration of chromosome unraveling down to the DNA
Drug design, drug delivery & technologies

First phase of synthetic human genome project successfully completes

Dec. 5, 2025
By Nuala Moran
No Comments
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.
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Regulatory actions for Dec. 4, 2025

Dec. 4, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Aobiome, Celltrion, Polypid.
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Other news to note for Dec. 4, 2025

Dec. 4, 2025
Biopharma happenings, including deals and partnerships, and other news in brief: BCM, Biontech, Curevac, Corrixr, Formosa, Inhatarget, Iolyx, Merxin, Rxilient, Vaximm.
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In the clinic for Dec. 4, 2025

Dec. 4, 2025
Clinical updates, including data readouts and publications: ADC, Biogen, Black Diamond, BMS, Capricor, Clene, Eisai, Elevar, Iliad, Lantern, Muvon, Nuvation, Onco3r, Oncotelic, Pharvaris, Quadriga.
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Financings for Dec. 4, 2025

Dec. 4, 2025
Biopharmas raising money in public or private financings, including: Auxilius, Iolyx, Junevity, Triana.
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Appointments and advancements for Dec. 4, 2025

Dec. 4, 2025
New hires and promotions in the biopharma industry, including: Actithera, Biocardia, Dimerx, March, Realta, Thryv.
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