Apnimed 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 ...
View ArticleEndpoints 100 biotech survey: Welcome to the summer of biotech’s discontent
Biotech execs don’t quite know what to make of the new FDA chief. There’s been plenty of head-shaking about the controversial provocateur he named to run CBER. Robert F. Kennedy Jr. at ...
View ArticleAt-home screening startup Reperio Health raises $14M
Telehealth is becoming more comprehensive than a quick online visit. Portland, OR-based Reperio Health got its start in 2020 selling at-home testing kits for employers and health plans, but this year...
View ArticleOptura raises $6.5M to help evaluate healthcare AI programs
Healthcare is figuring out what AI to use in a crowded market. Optura says it can help tell you if what you are trying is worth it. The startup, offering a system designed to analyze ...
View ArticleWeight loss startup Calibrate replaces CEO in leadership shakeup
Calibrate has replaced its CEO and made several other executive changes, Endpoints News has learned, the latest leadership reset at the once high-flying weight loss company. Rob Rebak, a veteran CEO of...
View ArticleTrump administration reveals 'most favored nation' drug price country targets
The Department of Health and Human Services provided the first details for how it plans to tie US drug prices to rates paid in similarly developed countries as part of President Donald Trump’s most...
View ArticleSV Health’s $269M dementia fund; Schrödinger lays off 7% of staff
Plus, news about Beckley Psytech, Regenxbio, Blueprint Medicines, VantAI, NovelMed and Bayer: 💰 SV Health closes second dementia fund: The London-based biotech investment firm closed its second...
View ArticleTourmaline Bio's heart drug cuts inflammation as it seeks to compete with...
Tourmaline Bio's experimental drug for atherosclerotic heart disease reduced markers of inflammation in the blood in a mid-stage study. The company must now show the drug cuts key events such as heart...
View ArticleFuture Covid vaccine approvals may narrow to older adults, high-risk people
FDA chief Marty Makary and new CBER Director Vinay Prasad said that future Covid-19 vaccine approvals will focus on adults over 65 and high-risk people 6 months to 64 years old, aligning US policy with...
View ArticleRFK Jr. spars with senators over HHS budget and research cuts
Senate Democrats grilled HHS Secretary Robert F. Kennedy Jr. on Tuesday over gaps in his budget and funding cuts that have halted or eliminated key clinical research. For the most part, Kennedy pleaded...
View ArticleCRISPR Therapeutics partners with siRNA company, showing that gene editing...
The gene editing company CRISPR Therapeutics struck a deal worth $95 million upfront with China-based biotech Sirius Therapeutics to jointly develop its experimental gene-silencing siRNA drug for blood...
View ArticleUpdated: FDA adcomm splits votes on Genentech and J&J cancer drugs
The FDA's Oncologic Drugs Advisory Committee voted 8 to 1 against whether Genentech's pivotal trial is applicable to the US patient population for a Columvi label expansion. In the afternoon session,...
View ArticleVinay Prasad makes first major imprint on FDA with new vaccine policy
Two weeks into his tenure leading the FDA’s biologics center, Vinay Prasad has made his mark with a new framework for approving future Covid-19 vaccines that he feels will counteract existing “dogma.”...
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