#ASGCT25: Lower conference attendance mirrors challenged cell and gene field
NEW ORLEANS — The annual American Society of Gene & Cell Therapy meeting felt quieter this year, amid federal funding cuts and a tough time for the sector as a whole. While conference organizers...
View ArticleAmarin urges Supreme Court to decline Hikma's drug label spat
The US Supreme Court should decline to review a generic drug labeling fight between Amarin and Hikma Pharmaceuticals because the case is “intensely fact-bound” and Hikma’s arguments are...
View ArticleFDA raises issues with four cancer drugs ahead of adcomm
The FDA on Friday raised efficacy, safety and trial design issues surrounding three new cancer drug indications and one new cancer drug ahead of a two-day meeting of its Oncologic Drugs Advisory...
View ArticleDeputy FDA chief mulls shaking up PDUFA reauthorization structure
The FDA is prepping to renegotiate its multibillion-dollar, quinquennial user fee agreements with the drug industry later this summer, and a new deputy commissioner on Friday suggested the structure of...
View ArticleHHS can require approval for drugmakers to apply 340B rebate models, court rules
The government “did not act contrary to the law” by requiring drugmakers to seek approval before implementing proposed new 340B rebate models, a federal judge ruled. The decision marks a key win for...
View ArticleSarepta seeks to expand Duchenne gene therapy Elevidys use to toddlers
Sarepta Therapeutics is meeting with the FDA in June to discuss expanding the use of its Duchenne muscular dystrophy gene therapy to patients younger than 4 years old. The outcome could serve as a...
View ArticleWhat we know about ‘most favored nation’; GSK’s $1.2B MASH deal; Bayer...
Happy Saturday and welcome back to Endpoints Weekly! We had a flurry of news this week, so let’s dive in. Our team has the latest news and analysis around the Trump administration’s executive order...
View ArticleNovavax wins FDA approval of Covid shot after delay, with restrictions
After more than a month of waiting and negotiations with US regulators, Novavax has gained FDA approval for its Covid shot. But it’s for a tighter population than the company had asked for, and signals...
View ArticleApnimed posts first set of Phase 3 sleep apnea results, aims for approval...
Apnimed's oral drug met the efficacy bar in the first of two Phase 3 studies in obstructive sleep apnea, the biotech said Monday morning. It plans to report results from a second Phase 3 trial ...
View ArticleCellCentric raises $120M to treat multiple myeloma with capsule
CellCentric has raised a $120 million Series C round to support a potential accelerated approval in multiple myeloma, the UK biotech exclusively told Endpoints News. The company, more than two decades...
View ArticleRegeneron plans to buy 23andMe for $256M
23andMe has found a buyer. Regeneron will buy the struggling 23andMe through its court-supervised sale for $256 million, the companies disclosed Monday morning. The move comes after a roller coaster...
View ArticleIonis details late-stage data for heart drug; Armata’s promising staph...
Plus, news about Applied Therapeutics and Acadia: ❤️ Ionis’ Phase 3 data for cardio drug: It said that two different doses of olezarsen reduced triglycerides by a placebo-adjusted 61% and 58 ...
View ArticleDavid Liu, Sam Sternberg unveil new way to insert big genes in human cells
Researchers have devised another way to insert large genes into precise spots in human cells, adding a serious contender to the increasingly heated race of technologies broadly known as targeted gene...
View ArticleIntellia's CRISPR therapy likely causes 'permanent' gene knockdown in ATTR...
Intellia’s CRISPR-based therapy maintained reductions in the levels of a misfolded protein in the nerves of patients with a rare disease called transthyretin amyloidosis. Functional improvement was...
View ArticlePrime Medicine sidelines only clinical program, replaces CEO and lays off...
In gene editing, scientific milestones and promising early data do not always mean a program is valuable. Prime Medicine announced Monday morning what it called “breakthrough” clinical results from the...
View ArticleBoehringer Ingelheim’s late-stage data for lung disease candidate underwhelm...
Boehringer Ingelheim claimed two Phase 3 wins for its PDE4 inhibitor in fibrotic lung diseases, but some Wall Street analysts said the candidate’s “modest” efficacy and limited combination potential...
View ArticleStelara biosimilars look to gain traction, helped by recent lessons from Humira
AbbVie's defense of its megablockbuster Humira may go down in the history books as the poster child for blocking biosimilar competition, but the launch of six Stelara biosimilars this year shows how...
View ArticleWhy Regeneron is buying 23andMe
Regeneron is doubling down on its genetics research ambitions by agreeing to buy most of 23andMe’s business out of bankruptcy. Regeneron is best known for developing blockbuster drugs like Dupixent and...
View ArticleRetro Biosciences inks blood disorder deal as Sam Altman-backed biotech seeks...
A longevity startup called Retro Biosciences is working on personalized blood disorder therapies thanks to a partnership with the Murdoch Children's Research Institute in Australia. The California...
View ArticlePfizer joins PD-1xVEGF race with $1.25B upfront to Chinese biotech 3SBio
Pfizer is set to enter the heated VEGF bispecific arena. Much like its peers, the New York drug giant is doing so by going to China in the battle for one of oncology's hottest classes ...
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