Daiichi and Merck's I-Dxd lung cancer study faces partial hold due to deaths
The FDA placed a partial hold on Daiichi Sankyo and Merck’s Phase 3 study of a lung cancer drug after the companies paused enrollment for what they called a "higher than anticipated incidence" of...
View ArticleUK committee demands ‘much-needed clarity’ on UK-US pharma trade deal
The head of a UK government committee has demanded more details on how the country is planning to fund the higher prices it will pay for medicines under its trade deal with the US. ...
View ArticleUS commission urges action as China's biotech sector advances
A US congressional commission is escalating its warning that the US could soon be eclipsed by China in biotech, after lawmakers took up some of its recommendations earlier this year. In a report...
View ArticleNovo obesity partner nabs Pfizer vet as CBO; CureVac's leadership clears out...
This is our final Peer Review in 2025. Thank you for reading the latest comings and goings for another year. Enjoy the holidays, and we’ll see you again on Jan. 9! → Kathy ...
View ArticleEndpoints at JPM 2026: What we'll be talking about
We’re a bit less than a month out from the JP Morgan meeting, where we'll host our own event on Monday and Tuesday that week in San Francisco. Every year is a ...
View ArticleCatalent handed two Form 483s, including for Sarepta gene therapy site
Prior to last month’s series of mass layoffs in Maryland, Catalent was issued two Form 483s for its gene therapy facilities in the state, which make products for Sarepta. The FDA handed both forms to ...
View ArticleJoe Jimenez's Aditum goes to Fosun for major biobuck-loaded collaboration
Aditum Bio, the biotech company creation firm from former Novartis leaders Joe Jimenez and Mark Fishman, has returned to China for another deal. This time, Aditum is forming a new company called ...
View ArticleAltimmune advances in MASH; New China obesity biotech; Ipsen Phase 2 fail
Plus, news on: EpimAb, Boehringer and Nxera, Syneron, Amphix Altimmune goes to Phase 3 in MASH: The drug developer's Phase 2 trial of pemvidutide, a GLP-1/glucagon agonist, failed in June. But based on...
View ArticleSenators point fingers over who blocked the rare disease voucher reauthorization
Sens. Bernie Sanders (I-VT) and Markwayne Mullin (R-OK) are not seeing eye to eye on why the Senate failed to pass legislation reauthorizing the FDA's rare pediatric priority review voucher program....
View ArticleBioMarin to pay $4.8B for Amicus and its rare disease drugs
BioMarin plans to dish out $4.8 billion to acquire Amicus Therapeutics and its two approved rare disease medicines, the California biotech said Friday. By gaining access to Amicus' meds for Pompe ...
View ArticleGalapagos' last asset posts mixed results as future remains in flux
Galapagos is flush with billions in cash, but it's not moving forward with its own pipeline. So what’s the Belgian biotech going to do with all of that money? The question resurfaced after Galapagos ...
View ArticleWhite House unveils nine more ‘most favored nation’ deals
The White House on Friday announced new deals with nine major drugmakers, finalizing an end-of-year push by President Donald Trump to make good on his “most favored nation” pledge for lower medicine...
View ArticleFDA approves Cytokinetics’ heart drug, giving it an edge over BMS rival
Cytokinetics has finally achieved its long-awaited goal of getting its first US approval. The company’s drug for a heart disease was approved in the US on Friday under ...
View ArticleNine more MFN deals; Western drugmakers turn to China; Chai Discovery's...
Welcome back to Endpoints Weekly! Before we get into this week’s headlines, here’s a holiday programming note: We won’t be sending our Saturday newsletter on Dec. 27 or Jan. 3. Our daily newsletters...
View ArticleAktis Oncology files for IPO to fund Lilly-partnered radiopharma pipeline
After a dormant couple of months, the biotech IPO market might crack open at the start of 2026. Aktis Oncology, a biotech in the buzzy radiopharmaceutical space, submitted its pitch for ...
View ArticleAstraZeneca bets up to $2B on Jacobio’s pan-KRAS inhibitor for cancer
AstraZeneca is spending $100 million upfront to secure ex-China rights for an early-stage cancer drug developed by Jacobio Pharma. The UK drugmaker will be responsible for advancing and selling the...
View ArticleBoehringer taps Rectify to create pills for chronic kidney disease
Boehringer Ingelheim will work with a Boston startup to develop oral medicines for chronic kidney diseases in a partnership worth up to $448 million in biobucks. The move boosts the profile of the...
View ArticleIpsen gains access to ADC from Shanghai biotech Simcere Zaiming
Ipsen extended its 18-month dealmaking streak, lining up an antibody-drug conjugate from Shanghai-based Simcere Zaiming. Paris-based Ipsen will pay $45 million upfront for access to an antibody-drug...
View ArticleShionogi to pay $2.5B to acquire one of the only approved ALS drugs
Japanese drugmaker Shionogi announced Monday that it will be taking ownership of one of the only approved ALS drugs in a multibillion-dollar deal, with implications for its broader ambitions in rare...
View ArticleWindward gets bispecific from Qyuns in its second China deal of the year
Swiss biotech Windward Bio is picking up a second drug candidate from a China biotech this year, seeking to bring multiple medicines to market for respiratory and dermatology conditions. Windward is...
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