The Latest
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China competitionDrugs from China are reshaping biotech. Track the licensing deals here.
Crescent BioPharma has licensed an ADC from China’s Kelun Biotech in a deal that will also see Kelun gain rights to a dual-acting cancer immunotherapy targeting the proteins PD-1 and VEGF.
Updated Dec. 5, 2025 -
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Hemophilia gene therapies are struggling on the market, even as innovation soars
The business case for hemophilia gene therapy still isn’t adding up due to persistent market barriers.
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Vaccines12 former FDA chiefs blast Prasad’s move to toughen vaccine standards
In an article published in NEJM, nearly all living ex-FDA commissioners lambasted the CBER head’s plans to use a probe into COVID vaccine safety to upend longstanding regulatory protocols.
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Tracey Beth Høeg, top Makary deputy, named head of FDA drug office
Høeg, a COVID-19 vaccine critic who’s been serving as a special assistant to the commissioner, will be the fifth person this year to run CDER amid heightening scrutiny of the agency.
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News roundupPraxis soars higher; Bristol Myers’ CAR-T therapy wins broader use
Praxis shares climbed another 40% on a pair of positive updates on two different drugs. Elsewhere, Bristol Myers’ Breyanzi was cleared for its fifth cancer indication and AstraZeneca expanded a rare disease deal.
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Emerging biotechAn Arch-backed biotech raises $53M to fight neurodegeneration
SciNeuro Pharmaceuticals represents the latest in a string of Arch investments directed at the nervous system, a notoriously challenging area of drug development.
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Courtesy of UniQure
UniQure slides further on outlook for Huntington’s gene therapy
Finalized minutes from a late-October meeting with the FDA confirm the agency doesn't see the data collected so far as enough to support an approval filing.
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Capricor soars on positive results for Duchenne cell therapy
Shares quadrupled now that the company appears on track to reverse an earlier FDA rejection of what could be the first treatment for heart-related complications of Duchenne.
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Deep Dive // Emerging biotechBiotech startups are built on venture capital. Track funding rounds here.
Three biotech startups, led by “molecular glue” specialist Triana Biomedicines, have raised more than $240 million combined in a trio of financing rounds announced over the last two days.
Updated Dec. 4, 2025 -
Permission granted by Bristol Myers Squibb
After finding ‘irregularities,’ Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis
Data from the "ADEPT-2" study, which analysts had hoped would arrive before year's end, are now expected sometime in 2026.
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Pharvaris’ pill succeeds in late-stage trial for rare swelling disorder
Phase 3 data could make the Dutch biotech's drug competitive in the increasingly crowded market of hereditary angioedema treatments.
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Richard Pazdur, FDA drug czar, to retire from agency
Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating what’s already been a turbulent year at the FDA.
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FDA details plan to scale back animal tests for some antibody drugs
The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.
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UK agrees to boost drug prices to dodge US pharma tariffs
A deal announced Monday will see the U.K. temporarily sidestep levies on Britain-originated drugs by loosening rules that restrain prices for new medicines.
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Emerging biotechWith $130M, Protego pushes forward a new type of amyloidosis drug
The startup’s lead prospect stabilizes abnormal proteins in patients with amyloid “light chain” amyloidosis, an approach that could represent a step forward compared to current therapies.
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Adeline Kon/BioPharma Dive
Deep DiveBiotech’s M&A outlook is uncertain. Track the deals that are happening here.
Since July, at least two dozen biotech acquisitions worth $50 million or more have been signed, and data compiled by BioPharma Dive show a third of those deals employed contingent value rights.
Updated Dec. 2, 2025 -
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Eli Lilly becomes first drugmaker to hit $1 trillion in market value
The pharmaceutical company’s success developing medicines for obesity has swelled its worth to levels associated with tech titans like Apple and Google and dwarfed that of its drugmaking peers.
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News roundup
Janux sinks on ‘overreaction’ to prostate cancer data; RFK Jr. replaces ACIP chair
Janux’s “masked” T cell engager had a lower response rate than reported last year. Elsewhere, Lilly dropped Zepbound’s price and ACIP named a new chairman days before a key vaccine meeting.
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Courtesy of Regeneron Pharmaceuticals
Gene editingRegeneron inks gene editing deal with startup Tessera
The big biotech, which has made genetic medicine a focus in recent years, is paying Tessera $150 million for rights to a potential one-and-done treatment for alpha-1 antitrypsin deficiency.
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Belite continues ascent as Stargardt drug hits mark in late-stage trial
The results position Belite, one of the sector’s top-performing companies since 2022, to seek approval of what could be the first marketed medicine for the rare eye condition.
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Adeline Kon/BioPharma Dive
Deep Dive // Emerging biotechBiotech IPOs are the industry’s lifeblood. Track how they’re performing.
Belite Bio raised only $36 million in a tiny IPO three years ago. But since then, shares have skyrocketed from $6 apiece to more than $150, giving the company a nearly $5 billion market value.
Updated Dec. 1, 2025 -
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Otsuka gains approval for first-of-its-kind treatment against rare kidney disease
In a rapidly heating market, Otsuka is the first to secure FDA clearance for an "anti-APRIL" therapy targeting IgA nephropathy.
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Novartis cuts hundreds of jobs; Novo’s dual-acting diabetes drug heading to Phase 3
The layoffs affect Swiss manufacturing facilities. Elsewhere, the FDA pushed back an approval deadline and a mid-stage study showed Novo’s amycretin helps regulate blood sugar.
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CMS sets 2027 Medicare prices for Wegovy, Trelegy and 13 other drugs
The second round of negotiations cuts spending an aggregate 44% over 2024 list prices as the federal government extends restraints over more medicines.
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How do Big Pharma employees rate their CEOs?
Top executives can steer large pharma companies in many ways. Here are the ones who employees approve of the most.
