FTC chairman seeks to revive PBM case
Federal Trade Commission Chairman Andrew Ferguson said he wants to bring back the agency’s case against pharmacy benefit managers, one day after the matter was put on hold because of the Trump...
View ArticleNovavax’s approval delay may signal warning for vaccine makers
On the precipice of FDA approval, Novavax's Covid vaccine is now in limbo while a decision to approve or reject it is held up. The delay reinforces a fear from other vaccine makers about how ...
View ArticleMarks was asked to provide non-existent vaccine risk data: WSJ
Ousted FDA biologics and vaccine chief Peter Marks was asked to provide non-existent data on the risk from measles vaccines, he told the Wall Street Journal in an interview describing the events...
View ArticleGSK and Pfizer resolve RSV vaccine patent fight
GSK and Pfizer have settled a lawsuit alleging Pfizer’s RSV shot Abrysvo infringed GSK’s patents. A Pfizer spokesperson told Endpoints News that as part of the settlement,“Pfizer has been granted a...
View ArticleTrump administration leaves obesity coverage expansion out of new Medicare rule
The Trump administration finalized new policies for some Medicare programs on Friday, but left out provisions that would have expanded coverage of anti-obesity drugs to millions of patients. Provisions...
View ArticleStaff cuts sweep across FDA; Tariff rollout raises questions; The R&D 15 is...
Welcome back to Endpoints Weekly! Much of this week’s headlines dealt with the fallout of cuts at the FDA and across HHS, notably including the ouster of CBER chief Peter Marks. Marks said he was ...
View ArticleQ&A: David Liu talks about science under pressure, teases “disease-agnostic”...
Gene editing pioneer David Liu was awarded one of three Breakthrough Prizes in Life Sciences for his invention of base and prime editing. The two CRISPR technologies, first published in 2016 and 2019,...
View ArticleGLP-1 weight loss discoverers win Breakthrough Prize: Q&A with Jens Juul Holst
Medicines based on glucagon-like peptide-1 (GLP-1) have revolutionized the treatment of diabetes and obesity. On Saturday, five scientists involved in the discovery and characterization of the peptide...
View ArticleGSK’s newest neuro pact is with ABL Bio, a Sanofi-partnered South Korean biotech
South Korean biotech ABL Bio has lined up another platform license agreement with a European pharma giant in the area of neurodegenerative diseases. ABL Bio has now garnered the interest of GSK, which...
View ArticleCell and gene therapy CDMO AmplifyBio shuts down over 'scarcity' of funding
Another CDMO has been hit by the slowdown of cell and gene therapy R&D. AmplifyBio closed its doors after struggling for months to find investor support and failing to find a buyer. “At the time ...
View ArticleRhythm touts Phase 3 win for rare obesity drug in people with brain damage
Rhythm Pharmaceuticals is looking to expand the potential market for its rare obesity treatment Imcivree beyond genetic disorders. The company said Monday the medicine reduced body weight in a...
View ArticleADC startup DualityBio seeks Hong Kong IPO amid precarious market
Multi-partnered ADC startup Duality Biologics is moving forward with its initial public offering plans on the Hong Kong Stock Exchange (HKEX). DualityBio expects to get net proceeds of about $176...
View ArticleLexeo discloses new data for heart drug; Spark Therapeutics to lay off workers
Plus, news about Kashiv BioSciences: Lexeo Therapeutics reveals early data for heart disease drug: The New York biotech said LX2006 produced “clinically significant improvements” in heart function...
View ArticleRayThera secures $110M in Series A raise
RayThera has collected $110 million in a Series A raise to help it advance a preclinical pipeline of small molecule drugs for immunological diseases. The San Diego-based biotech will use the proceeds...
View ArticleStock market melts down over Trump’s tariffs, and biotech's pain keeps growing
As President Donald Trump’s tariffs roil financial markets, biopharma is no exception. The XBI, an index fund viewed as the biotech’s market barometer, was down 3% in early trading Monday after closing...
View ArticleRFK Jr. won’t testify before key Senate committee this week on HHS overhaul
HHS Secretary Robert F. Kennedy Jr. won’t be appearing before a Senate panel on Thursday to testify on the massive restructuring of the health agency, despite an invitation from the committee’s...
View ArticleDrug tool and packaging makers to feel brunt of Trump tariffs, analysts say
Pharma tool and packaging production companies are readying themselves for direct impact from President Donald Trump’s tariffs, which could then have a knock-on effect on their biopharma and CDMO...
View Article‘This is self-inflicted’: Leerink’s David Risinger on the market shock and...
As the markets continued to fall Monday in response to the Trump administration’s tariff proposals, biotech has particularly been hit hard. The industry was already being hammered by firings at the FDA...
View ArticleRare disease hub at CDER and CBER faces new reality with staff crunch
Amy Comstock Rick joined the FDA last November, and she not only survived the widespread staff cuts last week, she's one of only a handful of FDA officials to speak at a live conference since ...
View ArticlePureTech rejects cash exit proposal from Nordic Capital after deal talks
PureTech Health, a Boston biopharma company that has created drug developers like Karuna Therapeutics and Seaport Therapeutics, confirmed on Monday that it was in discussions with Nordic Capital...
View ArticleFederal judge in Minnesota dismisses drugmakers' 340B lawsuits
A federal judge in Minnesota knocked down challenges from two drugmakers against a state law that the companies argued overly expanded the scope of the government's 340B drug discount program. Judge...
View ArticleHHS says it may revisit policy for anti-obesity drugs
The government said it “may consider future policy options” for anti-obesity medications, after declining to finalize a Biden-era proposal that would have expanded coverage to millions of Medicare...
View ArticleTrump administration hikes Medicare Advantage payments by $25B
The Trump administration will hike payments to Medicare Advantage insurers by more than $25 billion next year, according to an annual rate announcement released Monday afternoon. CMS said payments to...
View ArticleUS commission calls for $15B biotech investment to blunt China
A congressional commission is calling for at least a $15 billion federal investment in America’s biotechnology sector, warning that the US could soon be eclipsed by China in a key frontier of...
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