The Latest

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    Kendall Davis/BioPharma Dive
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    Deep Dive

    10 clinical trials to watch in the second half of 2024

    Study results are expected for two closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.

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    Daniel Tadevosyan via Getty Images
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    Two biotechs cut staff; AbbVie weathers biosimilar threat

    Glycomimetics and Cue Biopharma both revealed layoffs. Elsewhere, AbbVie’s earnings impressed Wall Street and an FDA panel recommended changing testing requirements for some lung cancer drugs.

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    Courtesy of Sanofi
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    Sanofi’s immunology bet starts to pay off

    Some analysts described Sanofi’s pipeline of immune system therapies, which includes more than half a dozen drugs in mid- to late-stage testing, as “underappreciated” by investors.

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    Elizabeth Regan / Industry Dive
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    Viking shares jump on plans to speed obesity drug into late-stage testing

    The drug’s advancement continued what one analyst described as a “torrid” pace for Viking’s closely watched medicine, which started human testing in 2022 and could reach a Phase 3 trial next year.  

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    Pfizer says hemophilia gene therapy meets late-stage study goal

    While the study results were positive, questions remain about the longer-term potential of hemophilia treatments like Pfizer’s.

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    Adeline Kon/BioPharma Dive
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    Deep Dive

    Biotech M&A is on the upswing. Track the latest deals here.

    As of mid-July, half of the 26 acquisitions worth at least $50 million in upfront value this year were of private biotechs, according to BioPharma Dive data.

    Updated July 23, 2024
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    Permission granted by Peyton Helbert / AAMI
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    FDA medical device chief Shuren to step down after 15 years

    Michelle Tarver, deputy director for transformation, will serve as acting director of the FDA’s medical devices office.

    FDA
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    Permission granted by Biogen
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    Biogen, Sage tremor drug fails key trial

    Known as SAGE-324, the drug was one of the key assets Biogen gained rights to through a billion-dollar research deal inked back in 2020.

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    Daniel Tadevosyan via Getty Images
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    News roundup

    Novartis invests in bispecifics for cancer; Bob Langer steps down from Moderna board

    The Swiss pharma is paying Dren Bio $150 million to partner on “targeted myeloid engagers.” Elsewhere, Geron is losing its commercial chief and Biovectra will sell to Agilent for $925 million.

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    Kena Betancur via Getty Images
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    Merck claims late-stage study success for RSV antibody

    The drug, a rival to Sanofi and AstraZeneca’s fast-selling Beyfortus, met its main goals in a Phase 3 trial. But undisclosed study results leave its full potential unclear.

    Updated July 23, 2024
  • A stylized illustration of a "patent thicket" for Jonathan Gardner's Nov. 1 story on Amgen's Enbrel.
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    Adeline Kon / BioPharma Dive/BioPharma Dive
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    Deep Dive // Patent thickets

    Drug patents protect pharma profits. Track when they’ll expire.

    The erosion of Humira’s U.S. sales is expected to accelerate, with analysts at Leerink Partners predicting a year-over-year sales decline of 32% when AbbVie reports earnings next week.

    Updated May 13, 2024
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    Naeblys via Getty Images
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    Autobahn raises $100M on investor interest in neuropsych drugs

    Autobahn’s lead candidate is designed to stimulate thyroid hormone receptors as a way to complement existing antidepressants.

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    3000ad via Getty Images
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    PBMs battle bipartisan scrutiny as lawmakers eye reforms

    Top executives at CVS Caremark, Optum Rx and Express Scripts made a rare congressional appearance to defend their companies’ drug pricing policies.

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    Peddalanka Ramesh Babu via Getty Images
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    Startup led by former J&J executives raises $165M for cancer, immune disease drugs

    Peter Lebowitz, who for years led J&J’s oncology R&D, is the CEO of the startup, called Third Arc Bio and launched by Omega Funds in 2022.

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    Permission granted by Bluebird bio
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    US government declines to clear Bluebird fertility support for Zynteglo patients

    The Health and Human Services' inspector general issued a "negative opinion" on Bluebird's request one week after Vertex sued the federal government over access to fertility preservation services.

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    Adeline Kon/BioPharma Dive
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    Deep Dive // Emerging biotech

    Biotech IPOs are the industry’s lifeblood. Track how they’re performing.

    With Artiva’s IPO, four immune drug developers have raised a combined $703 million in new stock offerings this year, surpassing the totals of all other therapeutic areas.

    Updated July 19, 2024
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    nopparit via Getty Images
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    Ionis plots next steps for Angelman drug Biogen passed on

    The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.

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    Mario Tama via Getty Images
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    J&J seeks expanded approval for antidepressant Spravato

    The company is seeking a monotherapy approval for Spravato, sales of which have climbed in recent quarters.

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    Anthony Kwan / Stringer via Getty Images
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    Global tech outage hits US hospitals

    At least 11 health systems were experiencing issues Friday after an update by cybersecurity firm CrowdStrike went awry.

    Updated July 19, 2024
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    Daniel Tadevosyan via Getty Images
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    News roundup

    Lilly alone in bidding for Morphic; Novartis won’t yet file MorphoSys drug

    Federal filings showed no companies other than Lilly made an offer to buy Morphic, while Novartis executives said they’re still waiting for more data on pelabresib.

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    Marcin Klapczynski via Getty Images
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    Emerging biotech

    Artiva prices $167M IPO, riding optimism for autoimmune cell therapy

    The offering comes days after the publication of a paper showing what analysts said was early proof that “off-the-shelf” cell therapies can treat inflammatory diseases.

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    Boehringer cuts price of Humira biosimilar in bid to build use

    The German drugmaker will offer a 92% discount on a copycat version of Humira for people who pay cash for the drug through GoodRx.

  • J&J HQ
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    Mario Tama via Getty Images
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    In strengthening Spravato sales, a positive sign for psychedelic drugs

    Jefferies analyst Andrew Tsai views growing sales for J&J’s depression treatment as evidence that psychedelics like it can be commercially viable.

    Updated July 23, 2024
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    Courtesy of Roche
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    Obesity pill from Roche shows promising weight loss in small study

    Treatment led to "clinically meaningful" weight loss over four weeks, but longer studies will be needed to compare it to Wegovy and Zepbound.

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    Justin Sullivan via Getty Images
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    Gilead’s CMO to depart next year

    Merdad Parsey joined Gilead as its chief medical officer in 2019 and has helped lead the company’s expansion into oncology, with mixed success.