UniQure restates FDA's negative feedback on Huntington's trial; Neurimmune's...
Plus, news about Pliant Therapeutics, Replicate Bioscience, Denali, Laigo Bio and Auxilius Pharma: 📉 UniQure's shares fall as it reiterates FDA's negative feedback on Huntington's study: The FDA
View ArticleBioNexus gets $500M to step into manufacturing; Thermo Fisher, AtomVie expand
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Blood testing company BioNexus Gene Lab has secured $500 million in...
View ArticleTrump administration pushes end-of-term deadline for ‘most favored nation’...
Large pharma companies that have made “most favored nation” deals with the White House will have until the end of President Donald Trump’s current term to fulfill some of their commitments to invest in...
View ArticlePrasad's claim of 10 Covid vaccine deaths may be an overcount: FDA sources
The number of child deaths allegedly caused by Covid-19 vaccines likely will be lower than the 10 initially mentioned in an internal email from FDA vaccines and biologics head Vinay Prasad, two agency...
View ArticleACIP delays vote on hepatitis B birth dose to Friday
The CDC’s vaccine advisory panel delayed a Thursday vote on when children should receive the hepatitis B vaccine, the second time they’ve postponed action in a period of confusion and frustration over...
View ArticleA year of scrutiny for health insurers
A year ago, we started our day chasing down the shocking news that UnitedHealthcare CEO Brian Thompson had been shot and killed outside a Midtown Manhattan hotel. The news, and especially the following...
View ArticlePraxis stops pivotal trial of rare epilepsy drug early for efficacy
Praxis Precision Medicines has stopped a trial of its sodium channel modulator in a rare brain disease early for efficacy. An interim analysis of the Phase 2/3 EMBOLD study found the once-daily pill,...
View ArticleEx-Intercept CEO takes over at Altimmune; Carolyn Bertozzi leaves Alnylam's...
→ Altimmune CEO Vipin Garg will pass the baton to chairman Jerry Durso on Jan. 1. Durso has been a member of the board since February and replaced Mitchel Sayare as ...
View ArticleGerman court stops Merck from selling subcutaneous Keytruda in patent battle...
Halozyme said a German court has blocked Merck from selling a subcutaneous version of Keytruda in the country. The decision marks an advance for Halozyme, which is in a broader patent dispute with...
View ArticleOTR Therapeutics gets $100M from Pfizer Ventures, others to build asset...
A new biotech has raised $100 million to build a mix of assets from inside and outside China, while developing its own drug candidates. The Shanghai-based startup, called OTR Therapeutics, is a new...
View ArticleBiopharma sentiment hit a turning point in October
Inside the two-week stretch that marked a reversal in biopharma sentiment. During the two weeks that our biopharma sentiment survey was in the field in mid-October, something unusual happened: The mood...
View ArticleRapport shares updated results from Phase 2 study of seizure drug
Rapport Therapeutics shared new data from a mid-stage trial of its seizure drug, saying that it demonstrates consistent efficacy over time and “across the spectrum of disease severity.” The results...
View ArticleDenali drug hold; Intercept layoffs; Capital raises for Immatics, Capricor...
Plus, news about Vanda, Hangzhou Highlightll Pharmaceutical and Guard Therapeutics. 🛑 FDA places hold on Denali Pompe drug: The FDA asked the biotech to update its protocol for a Phase 1 of its...
View ArticleNICE adds further details on how the UK will pay more for drugs
The UK’s National Institute for Health and Care Excellence (NICE) told stakeholders this week that previously rejected drugs won’t automatically fall under its new cost-effectiveness threshold....
View ArticleACIP drops universal hepatitis B birth dose recommendation
A panel of CDC vaccine advisors has stopped recommending that all children receive the hepatitis B vaccine at birth, overruling scientific consensus and public health officials who pleaded that there...
View ArticleBristol Myers expands Breyanzi approval to marginal zone lymphoma
Bristol Myers Squibb’s CAR-T therapy Breyanzi has become the first such treatment approved for patients with a rare, slow-growing type of non-Hodgkin lymphoma. The drug was approved Thursday for...
View ArticleORIC’s lung cancer pill shows promise in some settings but is dropped for...
ORIC Pharmaceuticals’ lung cancer pill showed encouraging efficacy as a first- and second-line treatment in lung cancer patients who have a specific genetic mutation targeted by the drug, part of a...
View ArticleACIP vote, more FDA turnover; Introducing Endpoints Signal; ARCH, Parker...
Welcome to Endpoints Weekly! We’re glad to be back after the holiday weekend. We have a lot to recap this week, starting with more change at the FDA. The agency tapped Tracy Beth Høeg as ...
View ArticleApple Tree Partners scores legal win against alleged holdout Russian investor
Investor Apple Tree Partners has won a crucial court victory against its main funder, after months of uncertainty about whether it would be able to continue putting money into the biotechs it has...
View Article#ASH25: As one door closes for Regeneron’s lymphoma bispecific, another reopens
ORLANDO — Regeneron is facing another twist in its roller-coaster ride to win US approval of its lymphoma treatment, odronextamab, after a series of regulatory and manufacturing hurdles. Earlier in...
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