UnitedHealth says it's facing a DOJ investigation
UnitedHealth Group is complying with formal criminal and civil requests from the Department of Justice about its Medicare program, the company said in a securities filing. The Thursday filing did not ...
View ArticleLEO Pharma’s eczema cream is approved in the US; Abivax’s $650M offering
Plus, news about Leads Biolabs and Gate Bioscience: FDA approves LEO Pharma’s eczema cream: The company’s JAK inhibitor, called Anzupgo, was approved in Europe in September. It’s now approved in the US...
View ArticleSarepta would have to conduct new studies to get back on market, FDA official...
Sarepta Therapeutics would need to conduct new studies to show the FDA that its Duchenne muscular dystrophy therapy Elevidys is safe, a senior FDA official told Endpoints News, amid what they described...
View ArticleRocket cuts 30% of staff as it plots path forward for gene therapies
Rocket Pharmaceuticals is laying off at least 80 employees over the next two weeks as it works on resolving a clinical hold, responding to a CRL from last summer and trimming its pipeline. The gene ...
View ArticleVaccine maker Bavarian Nordic confirms it's in potential takeover talks
Riding a recent wave of wins, Bavarian Nordic confirmed on Thursday that it has "been in discussions" with private equity firms over a potential takeover offer. The Danish vaccine maker said ...
View ArticleTwo House lawmakers seek biotech investments to counter China
WASHINGTON — US lawmakers are slowly coalescing around biotech as a national security imperative, building off a report released earlier this year that industry has touted as a blueprint for future...
View ArticleHow Sarepta's crisis over patient deaths unfolded, and what happens next
The call came just days before a 7-year-old boy was set to receive Sarepta Therapeutics' gene therapy Elevidys for his deadly disease. His family, which in May received a Duchenne muscular dystrophy...
View ArticleMemo Therapeutics plots Phase 3 trial for kidney infection drug despite...
Memo Therapeutics said Friday it is planning to advance its monoclonal antibody for kidney transplant patients with a viral infection into Phase 3 even though the drug didn’t pass a mid-stage test. The...
View ArticleCHMP recommends against Elevidys’ approval in Europe
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) said Friday that Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys should not be approved in Europe. The...
View ArticleGenerate's head of R&D returns to Merck; Galapagos shuffles leadership team
→ Alexandra Snyder has bid adieu to Flagship's Generate:Medicines, which slashed its headcount by 10% last week, after three years as CMO and EVP, R&D, and is returning to her old stomping ...
View ArticlePharma companies slow down their manufacturing projects in Ireland, data show
As President Donald Trump continues to threaten pharma tariffs, Ireland is starting to see a decline in foreign direct investments (FDI) from pharma companies as they start to relocate future...
View ArticleUpdated: Bristol Myers snags Cristian Massacesi from AstraZeneca as its new...
Bristol Myers Squibb is getting a new chief medical officer to steer its pipeline. Former AstraZeneca CMO Cristian Massacesi is set to take over from Samit Hirawat on Aug. 1, the ...
View ArticleEverest Medicines raises $200M; Epirium Bio targets $55M Series B
Plus, news about Lyell Immunopharma, ImmunityBio, Ab&B Bio-Tech, Sobi, Absci, Adicet Bio, Omeros, Pharvaris and Abivax: Everest Medicines raises $200M: The Shanghai-based drug developer forged a...
View ArticleFDA developing new flu vaccine framework to tackle 'problems,' senior...
The FDA is working on a new flu vaccine framework, which a senior FDA official told Endpoints News would address "a lot of problems" related to strain selection, year-over-year changes in efficacy, and...
View ArticleFDA delays decision date on Bayer’s hot flash drug
Bayer said the FDA has extended its review of the company’s hot flash treatment by up to three months. The FDA concluded that it needs additional time to review the nonhormonal drug elinzanetant, the...
View ArticleFDA investigates death of boy who got Elevidys, Roche says death unrelated to...
The FDA said Friday night that it is probing the June 7 death of an 8-year-old boy who received Elevidys, the Duchenne muscular gene therapy from Sarepta Therapeutics. A Sarepta spokesperson ...
View ArticleSarepta fallout continues; MAHA is angry as Loomer points fingers; A CAR-T...
Welcome to another edition of Endpoints Weekly! My usual weekly co-writer Nicole DeFeudis is still on vacation for her wedding, so this week I’m being helped out by Kyle LaHucik. Let’s get into the...
View ArticleShanghai biotech VelaVigo snags $60M after landing two licensing deals
VelaVigo has lined up another $60 million in venture funding to broaden its pipeline and continue hunting for additional partners, the biotech startup said Monday. The Shanghai-based biotech previously...
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