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BioWorld - Sunday, May 31, 2026
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Regulatory actions for Dec. 5, 2025

Dec. 5, 2025
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: J&D, Eli Lilly, Merakris, Uniqure.
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Other news to note for Dec. 5, 2025

Dec. 5, 2025
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.
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In the clinic for Dec. 5, 2025

Dec. 5, 2025
Clinical updates, including data readouts and publications: Apellis, Bioage, Bioarctic, Estrella, Immvira, Pliant, Sobi.
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Financings for Dec. 5, 2025

Dec. 5, 2025
Biopharmas raising money in public or private financings, including: Crescent, Denali, Etheros, Genmab, Royalty, Scineuro, Vaxil.
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Appointments and advancements for Dec. 5, 2025

Dec. 5, 2025
New hires and promotions in the biopharma industry, including: Hemostemix, Nona, Scineuro, Sudo, Trevi, Viromissile.
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Coins and charts
Biopharma financings November 2025

Biopharma funding normalizes as 2025 outperforms post-pandemic lows

Dec. 5, 2025
By Amanda Lanier
No Comments
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.
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Australian coins and bills

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

Dec. 5, 2025
By Tamra Sami
No Comments
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.
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Green and red bispecific antibodies

Crescent, Kelun in two-way deal, including PD-1/VEGF bispecific

Dec. 5, 2025
By Marian (YoonJee) Chu
No Comments
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.
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Brain and encephalography

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

Dec. 5, 2025
By Lee Landenberger
No Comments
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.
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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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