Biotech: Page


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    Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

    The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless founded a new startup and Novartis licensed another radiopharma drug.

    By BioPharma Dive staff • Nov. 19, 2024
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    Incyte sinks on setback for drugs acquired in $750M buyout

    The company paused testing of one candidate acquired in its April deal for Escient and scrapped another in a blow to its diversification plans.

    By Nov. 19, 2024
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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 or in reprogramming cells inside the body.

    By BioPharma Dive staff
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    Permission granted by Intellia Therapeutics
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    Gene editing

    CRISPR therapy from Intellia may ameliorate rare heart disorder, data suggest

    Phase 1 data indicate Intellia’s medicine could be a powerful treatment for a cardiac form of ATTR amyloidosis. But rival drugs are further ahead.

    By Ned Pagliarulo • Nov. 18, 2024
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    Q&A // Brain drug revival

    How a Biogen drug set the stage for a new biotech targeting ALS

    Trace Neuroscience, which launched this week with $101 million, benefited from last year’s approval of Qalsody. Its CEO spoke with BioPharma Dive about how the company came together.

    By Nov. 15, 2024
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    Joey Sirmons / BioPharma Dive/BioPharma Dive
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    ‘Find any advantage’: 3 biotech leaders on driving R&D success

    “Many companies just iterate indefinitely without ever making progress toward an actual drug,” said one biotech VC on a panel hosted by BioPharma Dive. 

    By Nov. 15, 2024
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    Joey Sirmons / BioPharma Dive/BioPharma Dive
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    Emerging biotech

    Surviving in biotech’s new normal: 5 tips from industry VCs and CEOs

    At an event hosted by BioPharma Dive, drugmaker executives and investors discussed the importance of focus, smart spending and maintaining lines of sight to the clinic.

    By Ned Pagliarulo , Nov. 15, 2024
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    Halozyme bids for Evotec; BeiGene gets a new name

    The San Diego biotech made an unsolicited bid to buy Evotec for 2 billion euros. Elsewhere, Bluebird recorded its first Lyfgenia revenue and Leerink built up its M&A team.

    By BioPharma Dive staff • Nov. 15, 2024
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    Courtesy of Eisai
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    New Alzheimer's drugs

    Eisai wins over European regulators on Alzheimer’s drug Leqembi

    The EMA sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.

    By Nov. 14, 2024
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    Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy

    The company is paying China-based biotech LaNova Medicines $588 million for the same type of bispecific antibody drug that recently bested Keytruda in a clinical trial. 

    By Nov. 14, 2024
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    Kimberly White/Getty Images via Getty Images
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    23andMe to lay off more than 200 employees amid business struggles

    The genetic testing firm will also close its drug development arm. CEO Anne Wojcicki said the cuts are necessary to “focus on the long-term success of our core consumer business.”

    By Ricky Zipp • Nov. 13, 2024
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    Amgen shares sink on obesity drug concerns; AstraZeneca to spend $3.5B on manufacturing

    An analyst note raising questions about Amgen’s MariTide triggered a stock sell-off Tuesday. Elsewhere, Roche and Novartis struck drug discovery deals.

    By BioPharma Dive staff • Nov. 13, 2024
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    Metsera raises $215M to accelerate obesity drug plans

    With promising Phase 1 results in hand, Metsera hopes to develop a longer-lasting GLP-1 injection along with other types of obesity treatments.

    By Kristin Jensen • Nov. 13, 2024
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    TRex Bio raises $84M to compete in crowded immune drug field

    The California biotech has drawn partnerships with Eli Lilly and J&J on the promise of its approach to rebalancing the immune system.

    By Nov. 13, 2024
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    Thomas Lohnes via Getty Images
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    BioNTech to buy Biotheus, gaining control of cancer bispecific

    Biotheus’ antibody drug targets PD-L1 and VEGF, a design that’s high on drugmakers’ radars after the success of Summit Therapeutics’ ivonescimab.

    By Nov. 13, 2024
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    GSK partners with Flagship startup to hunt for Parkinson’s drugs

    Under deal terms, GSK will give Vesalius Therapeutics $80 million in upfront and equity payments to identify treatments for Parkinson’s and another neurodegenerative condition.

    By Nov. 12, 2024
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    Biotech investors, including Third Rock, pump $100M into a startup’s genetic medicine for ALS

    Trace Neuroscience aims to advance an RNA-binding therapy designed to preserve — and potentially improve — muscle function in people living with the nerve-destroying disorder.

    By Nov. 12, 2024
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    FDA approves new CAR-T competitor to Gilead’s Tecartus

    Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the brand name Aucatzyl.

    By Nov. 11, 2024
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    Sarah Silbiger via Getty Images
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    FDA lifts pause on Novavax flu vaccine trials

    After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination. 

    By Nov. 11, 2024
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    Shutterstock/Ad_hominem

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    Sponsored by LabConnect

    7 steps to selecting the right global central lab

    Unlock global clinical trial success with seamless sample logistics and standardized testing.

    Nov. 11, 2024
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    Permission granted by Cullinan Therapeutics
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    Sponsored by Cullinan Therapeutics

    Fueling accelerated drug development in autoimmune diseases with a modality-agnostic approach

    Innovation-without-borders philosophy seeks to bring forward only the most promising therapies.

    By Cullinan Therapeutics • Nov. 11, 2024
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    Kalaris to go public via reverse merger with AlloVir

    After Kalaris and AlloVir combine, the new company will have about $100 million to advance a treatment for age-related macular degeneration.

    By Updated Nov. 8, 2024
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    Tezspire succeeds in chronic rhinosinusitis; Gilead writes down Trodelvy value

    AstraZeneca and Amgen's drug could have a new use after positive Phase 3 study results. Elsewhere, Jazz set new plans for a narcolepsy drug and CDMO Avid Bioservices agreed to be taken private.

    By BioPharma Dive staff • Nov. 8, 2024
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    Athira exploring strategic alternatives after Alzheimer’s failure

    On the heels of its most advanced medicine flunking a key study, the drugmaker is looking at the different paths it could take to “maximizing stockholder value.”

    By Nov. 8, 2024
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    Jacob Bell/BioPharma Dive
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    Moderna earnings beat forecasts, but analysts question whether sales spike will last

    Sales of Moderna’s COVID-19 shot exceeded expectations, but the company’s launch of its new RSV vaccine has started slowly.

    By Ned Pagliarulo • Nov. 7, 2024
  • A Sarepta logo is displayed on a building in Cambridge, Massachusetts on Sept. 5, 2024.
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    Jacob Bell/BioPharma Dive
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    Sarepta scraps a Duchenne drug as gene therapy sales rise

    Elevidys sales have increased since the FDA made a controversial choice to expand the therapy's use. Meanwhile, Sarepta is abandoning a successor to its drug Exondys 51, citing an “evolving" treatment landscape.

    By Kristin Jensen • Nov. 7, 2024