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Halda adds $126M to test oral drugs for prostate, breast cancer

Connecticut biotech Halda Therapeutics, created by Arvinas founder Craig Crews, has reeled in another $126 million to start clinical testing of its oral molecules for solid tumors. With the new money,...

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Pfizer touts strength of RSV vaccine in subgroup of younger immunocompromised...

A few months after touting its RSV vaccine’s effects on younger adults, Pfizer said a sub-study focusing on immunocompromised adults is also positive. The data could offer another boost to its efforts...

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Ascendis scores FDA approval for hypoparathyroidism candidate to replace...

Ascendis Pharma announced Monday that it won FDA approval for its hypoparathyroidism drug, offering the small community of those suffering from insufficient levels of parathyroid hormone another...

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Tenax 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...

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Three 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...

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Novo 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...

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Revance 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...

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Legend 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...

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Pressure 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...

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J&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...

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Lawmakers 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...

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Galderma 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...

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CSL 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...

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Kyverna 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...

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IRA 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...

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Federal 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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Rivus posts a win for its experimental obesity drug in heart failure patients

Rivus Pharmaceuticals’ experimental cardiometabolic drug, HU6, nailed a mid-stage trial in obese patients with heart failure, finding that patients notched a statistically significant reduction in...

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Lexicon cuts about 75 sales jobs to prep for drug launch early next year

Ahead of an FDA decision date later this year, Lexicon Pharmaceuticals is trimming its workforce. The company will lay off roughly half of its sales and commercial teams, it announced Tuesday,...

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