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Four phase 3 wins with no numbers disclosed – This Week in Biotech #119
Roche, Amgen, Merck and Otsuka all announced Phase 3 wins without effect sizes, Telix pays $1.65B for a rejected drug, and Lilly’s once-weekly insulin…
Sep 25
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Katerina Roznik
15
1
1
The best small cell lung cancer data in 30 years, and the argument over whether to believe It – This Week in Biotech #118
Two B7-H3 antibody drug conjugates cut death risk 54% in relapsed SCLC, Gilead and Merck's trial only worked in Chinese patients, and Novartis loses its…
Sep 18
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Katerina Roznik
10
3
1
Novartis had the worst day in its history and the FDA approved a drug its advisers rejected, again – This Week in Biotech #117
Pelacarsen misses in 8,323 patients, del-desiran fails five months after a $12B acquisition, and the FDA approves a drug its own advisers voted 6-3…
Sep 11
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Katerina Roznik
8
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
8
1
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
8
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
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