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26 manufacturers struck MFN pricing agreements. Pfizer’s Albert Bourla anticipates neither changes nor codification. Leerink Partners notes the tariff exemptions expire Dec. 31, 2028. What does Leerink expect?
Watchdog Wednesday. Read it here...
capsul.news/watchdog-wednesd…
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PDUFA reauthorization expires Sept. 30, 2027. In 2022, Congress cut the last renewal so close that FDA warned user-fee-funded staff they might lose their jobs. “The real danger is timing.”
Watchdog Wednesday. Read it here..
capsul.news/watchdog-wednesd…
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Democrats will have subpoena power, and likely targets include the MFN deals and the CNPV program, as well as the Administration’s mifepristone and vaccine policies. What should sponsors do?
Watchdog Wednesday. Read it here...
capsul.news/watchdog-wednesd…
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Democrats will take both chambers of Congress in January, yet Republicans still have the Presidency, and with it the veto pen and the regulatory machinery. What does that mean for biotech executives?
Watchdog Wednesday. Read it here...
capsul.news/watchdog-wednesd…
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The UK ranked seventh for Phase III in 2025, behind Spain, Germany, Italy and Poland. ABPI’s Joe Edwards says it “must now deliver that across the whole trial, not just at the first site.” What does the ABPI want?
Trial Tuesday. Read it here...
capsul.news/trial-tuesday-uk…
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Capsul News retweeted
@CapsulNews isn't written for people who follow biopharma. It's written for the people who already work inside it.
A follower wants the summary. If you work in this industry, what you actually need is the signal underneath it.
You're already part of the story, whether you're sitting in the partnership meeting, reviewing the clinical data, or keeping an eye on the regulatory calendar.
What's often missing is the context that never made it into the announcement itself.
So that's who we write for: the people deciding which partnerships are worth pursuing, which data actually holds up, and which regulatory signal is worth acting on before the rest of the market catches on.
One newsletter, six minutes, and the rest of what you needed to know.
Capsul. Biopharma's Daily Dose. Free for a limited time.
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Industry’s share of NHS interventional trial enrollment: 3.8% in 2025/26, down from a high of 13.2% in 2017/18. The ABPI calls the trend “worrying” and offers its reading of the cause.
Trial Tuesday. Read it here...
capsul.news/trial-tuesday-uk…
In 2025/26, 35% of UK commercial studies opened to patients within 60 days of approval. The target: 90%. The ABPI argues the government’s metric gives only a partial picture. What’s missing?
Trial Tuesday. Read it here...
capsul.news/trial-tuesday-uk…
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The UK now averages 112 days to set up a trial, down from more than 250 in 2022. Yet enrollment in NHS commercial contract trials has fallen for a fifth consecutive year. What happens after the yes?
Trial Tuesday. Read it here...
capsul.news/trial-tuesday-uk…
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AbbVie went back to a familiar partner. Nxera licensed it an EP4 agonist program for IBD: $100m up front, up to $1.37 bn in milestones, plus royalties. A $100m second chance for a shelved drug.
Milestone Monday. Read it here...
capsul.news/milestone-monday…
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One Karyopharm Phase III trial met one co-primary endpoint but missed the other. Another missed its primary endpoint. On Nov. 2, it filed for Chapter 11 and agreed to merge with Ayrmid. That's only part of the story.
Milestone Monday. Read it here...
capsul.news/milestone-monday…
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