Vertex pauses study of mRNA therapy for cystic fibrosis
Vertex paused an early-stage trial of its inhaled treatment for cystic fibrosis that came from a partnership with Moderna. The biotech said Monday in its first-quarter press release that it's...
View ArticleAnti-aging biotech NewLimit raises $130M Series B round
NewLimit, an anti-aging biotech startup backed by Coinbase CEO Brian Armstrong, has raised a $130 million Series B round to get its lead drug candidates closer to human testing. The South San...
View ArticleControversial doctor Vinay Prasad named CBER director
FDA Commissioner Marty Makary named Vinay Prasad as the next director of the Center for Biologics Evaluation and Research, Endpoints News has learned. In an email to staff reviewed by Endpoints, Makary...
View ArticleEurope pledges €500M to attract global science talent
The European Union is committing €500 million ($556 million) over the next two years to make Europe a “magnet” for researchers from around the world. The funding was announced Monday by European...
View ArticleTrump, FDA zero in on foreign factories to give domestic sites an edge
With several large pharma companies promising billions of dollars to reshore manufacturing to the US, President Donald Trump and the FDA have started on plans that would give current and future...
View ArticlePlans to match US drug prices to those overseas gain steam in Washington
House and Senate lawmakers from both parties are working with the Trump administration on proposals that would use drug prices paid by other developed countries as a reference for the US, an idea that...
View ArticleSEC expected to drop investigation of Illumina's $8B Grail deal
The SEC is expected to drop an investigation into Illumina's $8 billion acquisition of cancer test developer Grail, Endpoints News has learned. In 2023, Illumina disclosed in a regulatory filing that...
View ArticleStates sue US over plan for reorganization of federal health agencies
Attorneys general from 19 states and Washington, DC have filed a lawsuit against the federal government alleging that its plan for a broad restructuring of health agencies is “an unlawful effort to...
View ArticleSarepta’s stock plummets after Prasad appointment, low Elevidys sales
Sarepta Therapeutics had a bad day in Washington. And then a worse one on Wall Street. On Tuesday, the company's stock fell 27% following the news that Vinay Prasad would be the new head of ...
View ArticleMarea heads to Phase 2b after updated biomarker data show CV drug’s promise
Marea Therapeutics said on Wednesday that its lipid-lowering antibody cut both remnant cholesterol levels and remnant triglycerides — both indicators for cardiovascular disease in at-risk patients. The...
View ArticleVinay Prasad's FDA appointment sends biotech stocks lower
How did biopharma stocks react to Vinay Prasad’s appointment as director of one of the FDA's top jobs? Not well. Prasad, a hematologist-oncologist by training who gained prominence for criticizing the...
View ArticleNovo Nordisk Q1 earnings: Growth forecast trimmed as GLP-1 compounder ban yet...
Novo Nordisk said on Wednesday that compounding pharmacies’ production of its GLP-1 medicine semaglutide had reduced its market penetration more dramatically than it had expected — causing it to cut...
View ArticleCRISPR Therapeutics' gene editing therapy reduces bad cholesterol and...
CRISPR Therapeutics has revealed promising but early data from its first clinical study of a gene editing therapy to lower the risk of heart disease, setting the stage for competition with other...
View ArticleEndpoints livestream: What Vinay Prasad means for CBER and FDA
Today on our livestream, we talked about the surprise news that Vinay Prasad will replace Peter Marks at the FDA, and lead the Center for Biologics Evaluation and Research. You can ...
View ArticleTheriva’s oncolytic virus succeeds in pancreatic cancer study, but stock falls
Theriva Biologics' experimental oncolytic virus treatment and chemotherapy helped patients in a mid-stage study stay alive longer than chemotherapy alone. The company said Wednesday that the Phase 2b...
View ArticleCedars-Sinai partners with Redesign Health to build health tech startups
Los Angeles-based health system Cedars-Sinai is partnering with venture studio Redesign Health to build health tech startups from scratch, among other initiatives. The non-profit network of hospitals...
View ArticleNewAmsterdam's pooled Phase 3 data; C4 seeks partners for solid tumor degrader
Plus, news about Vivo Capital, Arcus Biosciences, Rigel and Voyager Therapeutics: NewAmsterdam shares pooled Phase 3 data: The company’s experimental CETP inhibitor obicetrapib reduced lipoprotein(a)...
View ArticleCharles River launches ‘strategic review’ alongside activist investor Elliott
Charles River Laboratories is set to start a strategic review and add four new board members after it settled on a “cooperation agreement” with Elliott Investment Management. The Wednesday announcement...
View ArticleJudge hands win to FDA, Lilly in tirzepatide shortage case
A federal court handed the FDA and Eli Lilly a major win in a case challenging the end of the tirzepatide shortage. On Wednesday, The US District Court for the Northern District of Texas denied ...
View ArticleDrugmakers to push back on Trump plan for 'most favored nation' prices
It was Wednesday afternoon last week at the White House, and President Donald Trump was working the room. There with him were CEOs from the world’s biggest companies, all of whom had pledged billions...
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