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Moderna Flu Filing Rejected, Sanofi Replaces CEO, AbbVie Sues Over Botox Medicare Pricing – This Week in Biotech #89
CBER’s Refusal to File jolts FDA predictability, Sanofi swaps CEOs, AbbVie sues over Botox Medicare pricing, and BridgeBio’s Phase 3 win contrasts with…
 • Katerina Roznik
Hims Launches Compounded GLP-1 Pill, CVS Forces Biosimilars – This Week in Biotech #88
Compounded semaglutide draws FDA scrutiny as Novo Nordisk guides 2026 lower and Eli Lilly leans into a $50 Medicare copay (Jan 30-Feb 5, 2026).
 • Katerina Roznik
Regenxbio FDA Hold, Sanofi Vaccine Demand Softness, and CMS Negotiation Expansion – This Week in Biotech #87
FDA pauses two AAV programs, Sanofi reports US vaccine uptake slipping, and CMS widens negotiations to more blockbuster drugs (Jan 23-29, 2026).
 • Katerina Roznik
Moderna Merck V940 Shows Five Year Melanoma Durability, Biopharma Deal Activity Picks Up – This Week in Biotech #86
KEYNOTE-942 durability, plus GSK’s $2.2B RAPT food allergy deal, BMS partners Janux, Corcept's overall survival win, and Corvus posts Phase 1 eczema…
 • Katerina Roznik
Drug Pricing Returns, AI Labs Scale Up, Gene Therapy Pushes Mainstream – This Week in Biotech #85
(Jan 9-15, 2026)
 • Katerina Roznik

Deep Dives

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Inside NImmune’s Phase 3 Push in Ulcerative Colitis
Founder Josep Bassaganya-Riera on omilancor, a gut-restricted oral therapy, precision biomarkers in inflammatory bowel disease, and the TITAN-X AI…
 • Katerina Roznik
Inside Sensible Biotechnologies: Reinventing mRNA Manufacturing
How an Oxford-born, YC-backed startup is betting that cell-based production will define mRNA’s next decade.
 • Katerina Roznik
How mRNA Could Defeat Latent Viruses and Train Immunity Against Cancer
Moderna and BioNTech deploy AI-driven mRNA to target CMV, EBV, HSV, and personalized neoantigen cancer vaccines. These trials could redefine…
 • Katerina Roznik and The Biotech Capital Compass
The mRNA Revolution: Beyond COVID to Cancer, Flu & Herpes Vaccines
How Moderna and BioNTech are expanding from COVID into CMV, EBV, HSV, and next-gen flu, while scaling personalized cancer vaccines (part 1 of the mRNA…
 • Katerina Roznik and The Biotech Capital Compass
Sarepta, Elevidys, and the Future of AAV Gene Therapy
Part 2 of a mini-series on gene therapies, from the perspective of a scientist and an investor.
 • Katerina Roznik and The Biotech Capital Compass
CRISPR in 2025: Clinical Use, Regulatory Pressure, and Future Promise
Part 1 of a mini-series on gene therapies, from the perspective of a scientist and an investor.
 • Katerina Roznik
Organoids, AI, and the FDA’s Move Away from Animal Models
Inside the FDA’s push to replace lab animals with human tissues & algorithms — with scientist Dr. Patrick Creisher.
 • Katerina Roznik
New contenders, old headwinds: global biotech looks to China
Western biotech faces a tougher funding climate, while Chinese firms move faster and aim higher, reshaping the industry’s global balance.
 • Katerina Roznik and Erin Mihealsick
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Moderna Flu Filing Rejected, Sanofi Replaces CEO, AbbVie Sues Over Botox Medicare Pricing – This Week in Biotech #89
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CDC Vaccine Schedule Shifts, Practice-Changing Phase 3 Wins, and Deal Heat – This Week in Biotech #84
Revolution takeover rumors, Amgen and Lilly pay early for platforms, plus phase 3 wins in gastroesophageal cancer, psoriasis, and hepatitis B amid a CDC…
 • Katerina Roznik
Biotech Heads Into 2026: Obesity, Vaccines, Pricing & Risk — This Week in Biotech #83
A year end / new-year update on what actually moved during the holiday stretch (Dec 19, 2025 – Jan 1, 2026).
 • Katerina Roznik
CEPI Rescues Moderna’s Bird Flu Vaccine and Takeda’s Delivers in Psoriasis — This Week in Biotech #82
From pandemic preparedness to late stage clinical wins, plus key FDA approvals and trial readouts that will shape 2026 (Dec 12-18, 2025).
 • Katerina Roznik
Fed Rate Cut Tailwind, Lilly’s Triple Agonist Delivers Big, Vaccine Policy Turmoil — This Week in Biotech #81
Plus Biohaven’s next-gen Trop2 data, Kymera’s STAT6 surge, AC Immune’s Parkinson’s signal, Mirum’s hepatitis delta bet, the CDC’s new Covid vaccine…
 • Katerina Roznik
Inside NImmune’s Phase 3 Push in Ulcerative Colitis
Founder Josep Bassaganya-Riera on omilancor, a gut-restricted oral therapy, precision biomarkers in inflammatory bowel disease, and the TITAN-X AI…
 • Katerina Roznik
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