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  • 3D Rendering of a Natural Killer Cell (NK Cell) destroying a cancer cell.
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    Marcin Klapczynski via Getty Images
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    With revised IPO pitch, Artiva touts ‘natural killer’ cell therapy for autoimmune disease

    Like many of its cell therapy peers, Artiva, which originally sought an IPO in 2021, has shifted its strategy to ride a wave of investor interest in autoimmune disease research.

  • Employees of biotechnology company UniQure work in a laboratory.
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    Courtesy of UniQure
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    UniQure, with sale of plant, outsources Hemgenix manufacturing

    The gene therapy developer, which cut jobs in October, expects the sale of a Lexington, Massachusetts, facility to Genezen to lower its cash burn.

  • The U.S. Supreme Court building's facade with flowers blurred in the foreground.
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    Andrew Harnik via Getty Images
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    Supreme Court overturns Chevron doctrine, limiting reach of federal agencies

    Federal courts will no longer have to defer to agency regulations for interpretation of ambiguous statutes, a ruling that could have significant impact on the FDA and CMS.

    FDA
  • A wall showing a Merck & Co. logo in Kenilworth, New Jersey
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    Courtesy of Merck & Co.
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    Merck’s pneumococcal vaccine gets CDC panel backing

    Advisers to the agency unanimously recommended use of Capvaxive in older adults and in certain younger ones, putting it in the same tier as Pfizer's competing Prevnar shot.

  • A stack of newspapers are seen against a blue background.
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    Daniel Tadevosyan via Getty Images
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    News roundup

    PTC faces another Duchenne drug rejection; Coherus sells Humira biosimilar

    European drug regulators voted for a third time not to renew the approval of Translarna. Elsewhere, Sanofi invested in a brain disease biotech and Esperion sold royalties to help pay off a loan. 

  • FDA headquarters with sign in foreground
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    Sarah Silbiger via Getty Images
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    Rocket gene therapy rejected by FDA over manufacturing

    The complete response letter follows other recent manufacturing-related rejections, including one for a cell therapy from Abeona Therapeutics.

    FDA
  • A photo of the street sign for Wall Street, in front of a row of American flags.
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    hapabapa via Getty Images
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    Emerging biotech

    ​​​​​​​Alumis cuts IPO size, but nets $250M for immune drug work

    Alumis’ public offering comes during an uptick in interest in immune drugs. Still, the company sold fewer shares than intended, and added a concurrent private stock issuance to boost its total haul. 

  • A podium showing the logo for the Centers for Disease Control and Prevention is seen.
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    Kevin C. Cox via Getty Images
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    RSV vaccines

    RSV vaccine makers’ shares fall as CDC adjusts shot guidance

    The new guidance more strongly urges vaccination in adults who are older or at higher risk, but removes a prior recommendation for adults aged 60 to 74 years without certain risk factors.

  • An AbbVie sign is seen on the outside of a building in California.
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    Courtesy of AbbVie
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    AbbVie expands its IBD prospects with $250M Celsius deal

    The pharma’s acquisition of Celsius is the latest in a string of deals by major drugmakers hunting anti-inflammatory medicines.

  • An illustration of CRISPR-cas9 gene editing
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    del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
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    First-of-its-kind Intellia data suggest CRISPR drug could be given more than once

    The findings provide early proof that multiple doses of a gene editing medicine can be safely administered with additive effects, overcoming a key constraint of the complex therapies.  

  • A photo of Bluebird bio employees in a laboratory.
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    Courtesy of Bluebird bio
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    2seventy slims down with sale of hemophilia assets to Novo

    Novo will pay $38 million in cash under the deal, which will also see 2seventy employees working on the program transfer to the Danish drugmaker.

  • Two prescription drug cartons are seen standing vertically on end, bearing the word Wegovy.
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    Scott Olson via Getty Images
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    Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?

    Obesity drugs like Wegovy are proving useful in many diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.

  • A sign reading Novo Nordisk is seen on the side of a building.
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    Victor Golmer via Getty Images
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    Novo nixes trial of blood pressure drug it bought in $1.3B deal

    The failure of a Phase 3 study led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.

  • A stack of newspapers are seen against a blue background.
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    Daniel Tadevosyan via Getty Images
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    News roundup

    Zealand hauls in $1B off obesity drug data; Curie.bio zeroes in on Series A’s

    Zealand capitalized on a stock surge following the release of early study results. Elsewhere, U.S. regulators rejected an AbbVie medicine and another well-funded AI drug discovery startup emerged. 

  • Faye Feller, executive vice president, chief medical officer, Geron
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    Permission granted by Geron
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    After 33 years, Geron’s first approval marks a turn in Nobel-winning science

    The decades-long story of how a novel type of blood cancer drug went from a scientific idea to an approved product.

  • An image of a neural cell, colored red, is seen on a black background.
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    koto_feja via Getty Images
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    Wave, with new data, plots path forward for Huntington’s drug

    The company plans to make a case to regulators for a new accelerated approval pathway. But investors didn't seem as hopeful, sending shares down by double digits.

  • An illustration of DNA against a blue abstract background
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    Olena_T via Getty Images
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    Emerging biotech

    Exsilio debuts with $82M, pitching a ‘leap’ forward for genetic medicine

    The company claims it can address some of the field’s limitations with medicines delivered via messenger RNA and lipid nanoparticles.

  • A large group of dosing pens for subcutaneous injection of anti-obesity medication piled in a heap.
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    aprott via Getty Images
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    Novo to spend $4B on US plant, adding to obesity drug production push

    The planned facility in North Carolina is Novo’s latest multibillion-dollar investment in the manufacturing of weight loss drugs, demand for which continues to outstrip supply.

  • An anatomical model of the heart sits on a desk in a doctor's office
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    Ivan-Balvan via Getty Images
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    Alnylam says heart drug succeeds in closely watched study

    Positive results from a Phase 3 trial of vutrisiran in transthyretin amyloidosis cardiomyopathy come eight months after the FDA rejected another medicine Alnylam developed for the condition.

    Updated June 24, 2024
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    Daniel Tadevosyan via Getty Images
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    News roundup

    Obesity drugs from Altimmune, Hengrui show potential; Lilly details Zepbound sleep apnea data

    The American Diabetes Association’s annual meeting provided a forum for early trial results on several would-be weight loss drug competitors.

  • A Novo Nordisk sign is seen on the side of a building.
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    hapabapa via Getty Images
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    Novo fills in positive picture for preventive hemophilia drug

    Phase 3 trial results should support an approval application for the drug, which analysts view as a competitor to Roche’s blockbuster medicine Hemlibra.

  • A photo of FDA CBER Director Peter Marks delivering remarks at a public workshop on March 3, 2020.
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    Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
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    Duchenne approval exposes FDA rift over Sarepta gene therapy

    Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.

    FDA
  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta
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    Sarepta Duchenne gene therapy wins broader use from FDA

    The approval makes Elevidys available to most Duchenne patients at least 4 years of age, despite mixed trial results that have led to skepticism about its effectiveness. 

    Updated June 21, 2024
    FDA
  • A logo of Gilead Sciences
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    Permission granted by Gilead Sciences
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    Twice-yearly shots of Gilead HIV drug effective in large prevention study

    Researchers recommended Gilead end testing early as lenacapavir proved 100% effective in protecting cisgender women in the Phase 3 trial.

  • A stack of newspapers are seen against a blue background.
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    Daniel Tadevosyan via Getty Images
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    News roundup

    Jazz drug for tremor fails study; Radiopharma drug developer ITM swaps CEOs

    A medicine Jazz acquired in 2019 missed the goal of a Phase 2 study. Elsewhere, Vanda rejected two takeover bids and Ashibio emerged from stealth with an antibody licensed from Gilead.