Teva, Novartis get new FTC warnings over Orange Book listings
The FTC is continuing its campaign against drug patents that it claims are improperly listed in an FDA database known as the Orange Book, carrying over an approach started under the Biden...
View ArticleFDA announces efforts to facilitate drug importation from Canada
The FDA said it is making “enhancements” designed to help states develop programs for importing cheaper drugs from Canada. The move follows an April 15 executive order directing HHS Secretary Robert ...
View ArticleFDA asks Covid vaccine makers to add more myocarditis data to labels
The FDA has asked for two Covid-19 vaccines made by Moderna and Pfizer/BioNTech to include new safety warnings on a type of heart risk, according to letters posted by the agency. The FDA asked the ...
View ArticleHinge Health prices IPO at $32 a share, $3B valuation
Hinge Health priced its shares at $32 per share, valuing the virtual physical therapy startup at around $3 billion in a closely-watched debut for the health tech industry. The share price is on the...
View ArticleFDA adcomm votes unanimously against Pfizer's prostate cancer drug combo
The FDA’s Oncologic Drugs Advisory Committee voted 8-0 against a new indication for Pfizer’s Talzenna in combination with Xtandi for first-line treatment of adults with non-homologous recombination...
View ArticleSanofi makes $470M move for Vigil's Alzheimer's drug, while another asset...
Sanofi plans to buy Vigil Neuroscience, a drugmaker advancing TREM2 agonism programs that derive from Amgen. The French pharma will acquire Vigil for its oral small molecule TREM2 project, dubbed...
View ArticleSelf-guided mental health apps can improve outcomes and lower costs: report
As the need for mental health treatment continues to grow, self-guided programs and digital therapeutics can lower spending and improve outcomes, a new report has found. The assessment, conducted by...
View ArticleSamsung Biologics to separate manufacturing and biosimilar businesses
Samsung Biologics is splitting apart its contract manufacturing and biosimilar development activities in a bid to enhance their competitiveness. Samsung Bio will become a pure-play CDMO while a new...
View ArticlePost-Hoc: AI bio needs to heed the overhyped history of CRISPR
John Evans can now reminisce about the days of unrealistic expectations. As CEO of the gene editing biotech Beam Therapeutics, Evans remembers when CRISPR buzz was at its apex, fielding questions at...
View ArticleEndpoints News is getting a new web address https://endpoints.news
Endpoints News is moving to a new website domain on June 1, 2025. The front door is now at: https://endpoints.news The goal is a seamless transition to a URL that is an exact match to our brand. If you...
View ArticleAn unpredictable year for healthcare
Every year, the venture firm Venrock conducts its annual “Healthcare Prognosis” survey that gauges how nearly 300 people across the healthcare industry feel about what’s ahead. This year, Venrock gave ...
View ArticlePharma companies consider 'first sale' rule to ease tariff impact
A little-known — but legal — trade principle is likely to be on pharma companies’ radars as they search for strategies to reduce exposure to President Donald Trump’s planned tariffs on the industry....
View ArticleThe ‘MAHA report’: What it says about vaccines, medicine and the pharma industry
The White House released its MAHA Commission report, detailing some of the Trump administration’s top priorities for revamping the US healthcare system and issuing a “call to action.” The 69-page...
View ArticleFDA names acting head of inspections; J&J again advocates for tax policies as...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. The FDA has selected Elizabeth Miller as its acting associate...
View ArticleCigna, Novo Nordisk offer lower GLP-1 prices
The sun is setting on compounding pharmacies’ ability to make copies of hot weight loss drugs. Pharmacy benefit managers, drugmakers and telehealth companies are lowering their costs to bring patients...
View ArticleHinge Health pops 23% as the digital health IPO market reawakens
Hinge Health shares {$HNGE} jumped 23% in its first day trading as a public company, setting the tone for digital health after a drought of IPOs in the sector. Shares of the virtual physical therapy ...
View ArticleMakary to senators: FDA staff cuts won't delay user fee targets
FDA Commissioner Marty Makary defended thousands of staff cuts during his first congressional hearing since taking office, seeking to reassure senators that review timelines for new drugs and devices...
View ArticleHouse passes Trump tax bill with PBM and orphan drug reforms included
The House of Representatives on Thursday morning passed President Donald Trump’s tax cut package, with steep Medicaid cuts, PBM reforms and changes to the government's drug price negotiation program...
View ArticleFDA vaccine advisors update Covid strain guidance following new framework
Almost three years ago, Vinay Prasad called a meeting of FDA vaccine advisors a “show trial.” On Thursday, as the director of the FDA center that regulates vaccines, he struck a ...
View Article#ASCO25: Jazz outlines full survival data for lung cancer drug Zepzelca
A drug from Jazz Pharmaceuticals that has yet to read out confirmatory data in lung cancer succeeded in another Phase 3 trial, as the company is slated to present overall survival data at the American ...
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