Regeneron gets another CRL, predicts delayed August PDUFA for Eylea HD
Regeneron's bispecific antibody has been rejected a third time, and the drugmaker expects delays to other pending FDA approvals for Eylea HD, it said during a second-quarter earnings announcement...
View ArticleAllogene says lymphodepletion drug caused patient death, changes CAR-T study...
Allogene Therapeutics reported that a patient in its pivotal off-the-shelf CAR-T trial died from liver failure after receiving an experimental lymphodepletion drug. The patient’s death occurred nearly...
View ArticleUnited Therapeutics' $1B share buyback; Layoffs at a Roivant subsidiary
Plus, news about Spine BioPharma, AbbVie, Novartis’ Leqvio, Novo Nordisk's Alhemo, TenNor Therapeutics, Vigonvita Life Sciences, Orchestra BioMed, I-Mab and Oculis: United Therapeutics' $1B share...
View ArticleSanofi buys China rights to Arrowhead’s lipid drug for $130M upfront
Sanofi will take the rights to Arrowhead Pharmaceuticals’ late-stage lipid-lowering asset plozasiran in China for $130 million upfront and up to $265 million in biobucks. The deal was struck through...
View ArticleAnalysts wary of Moderna's CMV fate after new endpoints added
A pivotal readout of Moderna’s cytomegalovirus vaccine candidate is on the horizon, with enough cases now accrued in the Phase 3 study for a final analysis this fall. But the company plans to add new ...
View ArticleRegeneron CEO speaks on Trump's 'most favored nation' pricing
Regeneron's CEO and co-chair said he agreed with President Donald Trump's view that European nations should pay more for new drugs. Leonard Schleifer's remarks on Regeneron's second-quarter earnings...
View ArticleFDA requires opioid label updates to highlight long-term risks
The FDA on Thursday required new safety label updates for all opioids to "further emphasize and characterize the risks associated with long-term use," following a May advisory committee meeting that...
View ArticleModerna gets UK appeals court win in Covid patent battle with Pfizer, BioNTech
A UK appeals court upheld the validity of a key Moderna patent, in a win for the biotech in its long-running legal fight against Pfizer and BioNTech over the three companies' rival Covid-19 vaccines. ...
View ArticleLilly to sell New Jersey facility as it nears picks for new US sites
Eli Lilly is selling its Branchburg, NJ manufacturing facility as it shifts capacity away from monoclonal antibodies and toward more complex forms of biologics, the drugmaker told Endpoints News. The...
View ArticleCMS considers pilot plan for covering weight loss drugs — report
CMS is considering a new program that would allow some state Medicaid plans and Medicare Part D to voluntarily cover GLP-1 drugs for weight management, according to a new report. The Washington Post
View ArticleReplimune says it's waiting for FDA on a path forward for rejected cancer...
Replimune is waiting for the FDA to further explain last week's surprise rejection of its advanced melanoma treatment before engaging in the formal process that pharma companies typically take to...
View ArticleEating disorder telehealth startup Equip raises $47M
Virtual eating disorder treatment startup Equip has secured $47 million in new funding, Endpoints News has learned. The fresh funding was led by private equity firm Adams Street Partners with...
View ArticlePrasad departs FDA; Merck cuts $3B in costs; Trump renews call for 'most...
Welcome back to Endpoints Weekly! I’m excited to be back after taking a couple weeks off to get married. Without further ado, let’s jump into this week’s headlines. Our team reported on Vinay Prasad’s...
View ArticleBioNTech sales grow, braces for FDA decision on updated Covid vaccine
BioNTech saw its sales rise and its net loss shrink in the second quarter of 2025 compared with the same period last year, the company said Monday. And the German company and its partner Pfizer ...
View ArticleBiogen is building a 'ventures' team to 'keep early portfolio externalized'
Biogen, which has spent the past few years attempting to reshape itself, is putting together a so-called "New Ventures" team that will invest in external research that it could one day bring in-house,...
View ArticleHansa says small trial shows its investigational drug could expand use of...
Hansa Biopharma said data from a handful of Duchenne patients suggest its drug candidate could open the door for more people to be treated with Sarepta’s gene therapy Elevidys. In an open-label trial,...
View ArticleThermo Fisher to lay off 85 workers in San Diego County; Lepu Biopharma inks...
Plus, news about Prime Medicine: Thermo Fisher is laying off 85 manufacturing workers: The cuts are spread across two Thermo Fisher sites in Carlsbad, CA, with 52 staffers being laid off from a site on...
View ArticleRoyalty market accelerates as XOMA acquires two biotechs and OrbiMed bags...
The royalty market is heating up, with two acquisitions and one of biopharma's largest investors announcing another major royalty fund on Monday morning. XOMA Royalty is acquiring vaccine developer...
View ArticleResearchers behind Replimune's melanoma study offer a rare protest of FDA's CRL
Typically, when the FDA sends out a CRL to a biotech for something other than, say, a routine manufacturing issue, the biotech puts out a vaguely-worded response about seeking clarity and then hunkers...
View ArticlePraxis' epilepsy drug cut seizure frequency in mid-stage trial
Praxis Precision Medicines' sodium channel drug cut seizure frequency in a Phase 2 trial, and the company expects to start a second registrational study for the experimental epilepsy therapy in the...
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