Hello, neffy: FDA approves first nasal spray for severe allergic reactions
Over the last 40 years, twin packs of EpiPens became a fixture for people and parents with children experiencing severe allergic reactions. Now, ARS Pharmaceuticals hopes that a new intranasal option...
View Article'Amgen India' to be operational later this year
With operations beginning in the fourth quarter, Amgen said Friday that it is opening a new site in Hyderabad, India, with 3,000 employees. Dubbed a tech and innovation facility to “accelerate digital...
View ArticleOhio federal judge dismisses IRA suit brought by US Chamber of Commerce
The federal government has defeated another lawsuit against the Inflation Reduction Act, this time brought by the US Chamber of Commerce. An Ohio federal judge dismissed the case on Thursday,...
View ArticleLykos’ MDMA-assisted PTSD treatment rejected by FDA after troubled trial and...
The FDA has rejected Lykos’ MDMA-assisted treatment for patients with post-traumatic stress disorder, a major setback for the company that had hoped to translate more than two decades of research into...
View ArticleLatest on MDMA rejection; Novo vs. Lilly earnings; Recursion, Exscientia to...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleTenax raises $100M; Sanofi buys into MeiraGTx
Plus, news about scPharmaceuticals and BiVictriX: Tenax Therapeutics’ $100 million PIPE: The company plans to put the money toward a second Phase 3 trial of an oral heart failure drug called...
View ArticleThree papers on MDMA are retracted by medical journal, just a day after...
Three articles detailing the mid-stage trial results of Lykos Therapeutics’ MDMA-assisted therapy were retracted by the medical journal that published them, citing a failure by the authors to disclose...
View ArticleNovo Nordisk gears up for FDA filing with late-phase insulin plus semaglutide...
Novo Nordisk, with data on-hand from a late-stage trial of IcoSema, is preparing for an FDA filing in type 2 diabetes slated for the second half of the year. IcoSema is a combination of Novo’s insulin...
View ArticleRevance to be acquired for $900M+ as Botox trade secrets lawsuit continues
Revance Therapeutics, the maker of Botox competitor Daxxify, will be acquired for more than $900 million. Crown Laboratories will buy out all of Revance’s stock for $6.66 per share, valuing Revance at...
View ArticleLegend continues Carvykti factory builds to cement CAR-T territory with J&J
Legend Biotech says it plans to further boost Carvykti manufacturing as the company and its partner Johnson & Johnson look to stay ahead in the CAR-T race against competitors Bristol Myers Squibb...
View ArticlePressure from anti-China legislation begins to ripple through biopharma
A latest round of SEC filings from biopharma companies shows at least a dozen companies highlighting the Biosecure Act as a major incoming risk, as they would have to transition away from many Chinese...
View ArticleJ&J receives support for $6.5B talc settlement — report
Ovarian cancer claimants have voted in favor of Johnson & Johnson’s proposed $6.5 billion talc settlement plan, clearing the way for its subsidiary to file for bankruptcy, Bloomberg reported...
View ArticleLawmakers renew calls for government to finalize march-in guidance
Sens. Elizabeth Warren (D-MA) and Angus King (I-ME), and Rep. Lloyd Doggett (D-TX) are once again urging the federal government to “immediately strengthen and finalize” the Biden administration’s...
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Why a new health tech venture firm is investing only in founders with a...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Create Health Ventures said Monday that it closed its first fund of $21 million to invest in health tech...
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Exclusive: Gates Foundation backs startup using optogenetics to manufacture...
A biotech startup called Prolific Machines believes that it can help cut manufacturing costs with carefully choreographed light shows that coax cells to keep pumping out drugs. And now it’s got backing...
View ArticleGalderma wins FDA approval for IL-31 drug in chronic skin disease
Galderma has secured FDA approval for a drug it licensed from Chugai Pharmaceutical in 2016 for a chronic skin disease known for its itchy bumps. On Tuesday, the US regulator greenlit Galderma’s...
View ArticleCSL Behring says uptake of hemophilia B gene therapy slower than expected
More than a year after launching the first-ever gene therapy for hemophilia B, CSL Behring revealed that it’s treated more than 12 patients so far and that it’s taken longer than expected to make...
View ArticleKyverna shares safety data for CAR-T; Evotec gets $75M milestone
Plus, news about Boundless Bio, Pelage, Actuate Therapeutics and Mersana Therapeutics: Kyverna Therapeutics touts early safety of CAR-T therapy: The biotech said the first 36 patients with autoimmune...
View ArticleIRA price negotiation results to be released Thursday — report
The Biden administration plans to share at least some results of IRA drug price negotiations on Thursday, according to a Politico report that cited anonymous sources. Negotiations were scheduled to end...
View ArticleFederal judge rules against Novartis in Entresto generic lawsuit
Novartis’ attempt to stop MSN Pharmaceuticals from launching a generic version of its blockbuster heart drug Entresto has hit yet another roadblock after a federal judge denied Novartis’ request for a...
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