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FDA official overruled her own review team to approve Replimune’s drug – This Week in Biotech #116
Internal memos reveal how Tudriqev got approved, three undisclosed deaths in Chinese trials trigger an FDA response, and Ultragenyx’s Angelman drug…
Sep 4
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Katerina Roznik
7
1
August 2026
FDA Approves a Pancreatic Cancer Drug in 35 Days – This Week in Biotech #115
Revolution Medicines’ Rasonque doubles survival in metastatic pancreatic cancer, Most favored nation pricing deals reach mid cap biotech, and Genentech…
Aug 28
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Katerina Roznik
10
2
Moderna mRNA cancer vaccine won Phase 3 in melanoma. The numbers come next
The stock tripled on a press release with no numbers in it. My read on what the trial proves, what it doesn't, and why thirty years of cancer vaccines…
Aug 27
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Katerina Roznik
7
1
3
42:09
Moderna gains 176% in a day on a melanoma vaccine trial – This Week in Biotech #114
Merck-Moderna's mRNA cancer vaccine hits Phase 3, three patient deaths surface in Chinese trials, and Trump nominates a new FDA commissioner (Aug 14-20…
Aug 21
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Katerina Roznik
8
NEJM retracts a registrational trial for the first time, plus Trump's childhood vaccine executive order – This Week in Biotech #113
Amgen's Tavneos pivotal study pulled after 9 patient endpoints were changed post-unblinding, Jazz buys Actio Biosciences, and Replimune's approval label…
Aug 14
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Katerina Roznik
7
FDA Approves Moderna's mRNA Flu Vaccine, Takeda's Orzeyful, and Replimune's Tudriqev – This Week in Biotech #112
Three first-in-class approvals in seven days, Lilly's $23B quarter crushes Novo again, and a rumored $400B AstraZeneca-Bristol Myers merger knocks 9…
Aug 7
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Katerina Roznik
4
July 2026
argenx's $2.2B Immunology Buy, J&J's In Vivo CAR-T Bet, and the FDA's Adcomm Revival – This Week in Biotech #111
argenx pays 86% premium for Forte's CD122 antibody, J&J commits $785M on in vivo CAR-T, and FDA panels turn on Capricor and Replimune (7/24-7/30, 2026).
Jul 31
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Katerina Roznik
13
2
Retatrutide Underdelivers, Novo Sues Lilly, and GSK Wins a Fast Lung Cancer Approval – This Week in Biotech #110
Lilly's triple agonist misses on cardiovascular outcomes, Novo Nordisk takes Lilly to court over "deceptively false" ads, and Trump threatens 200…
Jul 24
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Katerina Roznik
12
Merck's Oral PCSK9 Cholesterol Pill, Lilly's $2.8B Psychedelics Buy, and Makary's Regulatory Ghost – This Week in Biotech #109
Lipfendra becomes the first oral drug to match injectable cholesterol lowering, Lilly enters psychedelics with an $2.8B AtaiBeckley acquisition, and the…
Jul 17
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Katerina Roznik
20
2
4
AstraZeneca's Amyloid Miss, Vertex's $10B Crinetics Buy, and Kidney Disease's Two-Drug Race – This Week in Biotech #108
Eplontersen fails in a market its competitors already own, Vertex makes its biggest deal ever to diversify beyond cystic fibrosis, and Vera Therapeutics…
Jul 10
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Katerina Roznik
9
Happy 4th of July – This Week in Biotech #107
Roche beats two KRAS drugs at once, Anthropic starts making its own drugs, and biotech's XBI hits a five year high (June 26-July 2, 2026).
Jul 3
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Katerina Roznik
11
1
June 2026
Washington Tries to Outcompete China, Lilly’s $1.9B Abbisko Bet, and Pfizer’s $43B Seagen Question – This Week in Biotech #106
HHS unveils a clinical trial reform blueprint as Lilly doubles down on Chinese discovery, Pfizer's lung cancer ADC fails, and US health spending hits…
Jun 26
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Katerina Roznik
7
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