Biotech: Page 41


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    5 questions facing emerging biotech in 2024

    An unusual FTC challenge could have implications for startups, while industry watchers gauge whether the sector’s recent momentum will end a lengthy funding crunch.

    By Jan. 8, 2024
  • A photo of Ionis CEO Brett Monia and Metagenomi CEO Brian Thomas.
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    Permission granted by Ionis Pharmaceuticals and Metagenomi
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    Gene editing startup Metagenomi files for an IPO

    The Emeryville, California-based gene therapy developer has several preclinical programs in development with Moderna, Ionis and Affini-T.

    By Jan. 6, 2024
  • Colorized scanning electron micrograph of a natural killer cell from a human donor. Explore the Trendline
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    National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
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    Trendline

    Cell therapy

    The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

    By BioPharma Dive staff
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    An unusual drugmaker raises north of $100M for ecstasy-based PTSD therapy

    Lykos Therapeutics, formerly known as MAPS Public Benefit Corp., recently submitted its MDMA capsules for FDA approval, following two positive studies.

    By Jan. 5, 2024
  • Intellia Therapeutics headquarters in Cambridge, MA
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    Courtesy of Intellia Therapeutics
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    Intellia to lay off staff, cut some early research

    The CRISPR specialist joins some of its genetic medicine peers in trimming staff, announcing an “organizational streamlining” to focus resources on prioritiy drug programs.

    By Jan. 4, 2024
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    Allogene to shift strategy in bid to reposition CAR-T

    The company plans to restructure and will start a new late-stage study testing whether its “off-the-shelf” therapy can boost cure rates when used early on.

    By Jan. 4, 2024
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    Novo taps Flagship startups to develop drugs for obesity, MASH

    The research deals with Omega Therapeutics and Cellarity are the first under a broad alliance Novo struck with Flagship last spring.

    By Kristin Jensen • Jan. 4, 2024
  • A photo of the Moonwalk Biosciences founding team.
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    Permission granted by Erin Beach/Moonwalk Biosciences
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    A new startup from Feng Zhang and an ex-Illumina executive zeroes in on the epigenome

    Moonwalk Biosciences, the latest biotech co-founded by Zhang, joins other startups aiming to alter gene expression without changing DNA.

    By Jan. 4, 2024
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    Michael M. Santiago via Getty Images
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    Goldman Sachs gets into biotech investing with new venture fund

    The $650 million fund exceeded Goldman’s target and comes amid cautious optimism that biotech could rebound from a lengthy downturn.

    By Kristin Jensen • Jan. 3, 2024
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    Roche joins startup Remix in bet on another way to drug RNA

    The deal is the third Roche has formed with startups developing pills that target RNA, following similar pacts with Arrakis and Ribometrix.

    By Jan. 3, 2024
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    Tome acquires startup Replace, gaining new genome editing tools

    The deal is the second startup sale engineered by University of California, Berkeley scientist Shakked Halperin, and gives Tome a way to insert or delete small DNA sequences into the genome.

    By Jan. 2, 2024
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    Sara Silbiger via Getty Images
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    Ionis, Astrazeneca win FDA approval of competitor to Alnylam drug

    The clearance of Wainua for transthyretin amyloidosis opens up a new front in a long-running commercial battle between Ionis and Alnylam. 

    By Dec. 22, 2023
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    Clene says its ALS drug data is not yet enough for FDA

    The agency said initial trial evidence wouldn’t support an accelerated approval, according to the company, which plans to provide more data next year.

    By Dec. 21, 2023
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    Mario Tama via Getty Images
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    J&J bets bigger on MeiraGTx’s eye gene therapy

    Ahead of a Phase 3 readout that could come next year, the pharma is paying $130 million in upfront and near-term cash for rights to the retinitis pigmentosa treatment that it didn’t already own.

    By Dec. 21, 2023
  • Workers gather inside BioMarin’s gene therapy manufacturing plant in Novato, California.
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    Courtesy of BioMarin Pharmaceutical
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    BioMarin strikes deal with Elliott, agrees to review business

    Under pressure from the activist investor, BioMarin will add more independent directors and set up an operational review committee.

    By Kristin Jensen • Dec. 21, 2023
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    Argenx autoimmune drug study fails in blow to expansion hopes

    The Dutch biotech’s star product has lost some luster after a second failed Phase 3 trial in two months, this time for a skin condition called pemphigus.

    By Kristin Jensen • Dec. 20, 2023
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    Permission granted by Biogen
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    Biogen holds onto Tecfidera market in Europe for a little longer

    A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.

    By Ned Pagliarulo • Dec. 19, 2023
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    Point radiopharma drug results disappoint in prostate cancer study

    While the study met its goal, the drug’s benefit was less than analysts had predicted, an outcome that could hasten a planned takeover by Eli Lilly.

    By Ned Pagliarulo • Dec. 18, 2023
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    Structure shares sink as obesity pill misses expectations in small study

    Results from a Phase 2 trial fell short of what’s been seen with a similar Eli Lilly medicine, causing the closely watched biotech’s shares to plummet.

    By Dec. 18, 2023
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    Pivotal Life Sciences reloads with $389M, hunting for deals in a downturn

    The firm is tracking startups that launched during the biotechnology sector’s peak a few years ago but now need fresh funds to move their programs forward, one of its investors said.

    By Dec. 18, 2023
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    Carl Court via Getty Images
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    European regulators push Biogen, CRISPR drugs toward approval

    While a positive recommendation for the gene editing treatment Casgevy was expected, a clearance for Biogen’s Skyclarys has been no sure bet.

    By Dec. 15, 2023
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    Vir to lay off staff, cut costs amid setbacks building on COVID success

    The biotech is letting go of 75 employees and closing two R&D facilities, continuing a strategic reset under new CEO Marianne de Backer. 

    By Dec. 14, 2023
  • An image of Apellis Pharmaceuticals' vision loss drug Syfovre
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    Courtesy of Apellis Pharmaceuticals
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    Apellis eye drug likely to be rejected in Europe, company says

    According to Apellis executives, reviewers in Europe are skeptical of the benefits of its geographic atrophy medicine, Syfovre, and appear poised to recommend against approval at a meeting next month.

    By Dec. 14, 2023
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    Permission granted by Bristol-Myers Squibb
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    Bristol Myers pays SystImmune $800M and adds to pharma’s ‘ADC’ deal spree

    The lucrative alliance, potentially worth more than $8 billion, continues a run of dealmaking for a class of cancer drugs that’s surged in popularity in recent years. 

    By Dec. 12, 2023
  • An illustration of a gene being inserted into a helix strand.
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    Tome Biosciences debuts with $213M and a new way to edit the genome

    Based on the work of MIT scientists, the well-funded startup is developing ways to insert large sizes of genetic material anywhere in the genome without damaging or breaking DNA.

    By Dec. 12, 2023
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    Pricey new gene therapies for sickle cell pose access test

    Casgevy, the first CRISPR therapy approved by the FDA, will cost $2.2 million, while Bluebird’s competing genetic medicine is priced at $3.1 million.

    By Ned Pagliarulo • Dec. 8, 2023