Deep Dive

Industry insights from our journalists


  • Loper decision ending Chevron deference doctrine
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    Anna Moneymaker / Staff via Getty Images
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    FDA’s lab-developed test rule could be first test of agency’s power post-Chevron

    The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.

    Susan Kelly and Elise Reuter • July 11, 2024
  • An illustrated image of clinical development for a BioPharma Dive 2021 outlook story
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    Kendall Davis/BioPharma Dive
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    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.

    BioPharma Dive staff • July 1, 2024
  • An ion channel, colored yellow, is embedded in a cell membrane in this illustration.
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    Permission granted by Biohaven Ltd.
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    These microscopic tunnels are a goldmine for new medicines

    A growing cohort of biotechs, from Biohaven to Neurocrine to Jazz, hope research on ion channels will bring them new drugs and big business — much like it has done for Vertex.

    Jacob Bell • June 27, 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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    Drug patents protect pharma profits. Track when they’ll expire here.

    In addition to Sprycel’s looming patent expiration, Bristol Myers faces the prospect of generic competitors to Eliquis and Opdivo arriving later this decade.

    Jonathan Gardner • Updated May 13, 2024
  • A doctor holding a clipboard speaks to a women with a newborn baby.
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    SDI Productions via Getty Images
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    New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.

    The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.

    Delilah Alvarado • April 10, 2024
  • A person wearing a white coat works at a research laboratory bench.
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    Permission granted by Bristol Myers Squibb
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    Psychiatry drugs finally have pharma’s attention. Can they keep it?

    Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.

    Jacob Bell • April 8, 2024
  • An illustrated image of clinical development for a BioPharma Dive 2021 outlook story
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    Kendall Davis/BioPharma Dive
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    10 clinical trials to watch in the first half of 2024

    A non-addictive pain pill faces its definitive test, while study results in ALS and for a Duchenne gene therapy could have far-reaching implications. 

    Ben Fidler, Jacob Bell, Ned Pagliarulo, Jonathan Gardner and Delilah Alvarado • Jan. 2, 2024
  • A gloved hand holds a DNA microscope slide.
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    Massachusetts General Hospital

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    As ALS research booms, one treatment center finds itself in the spotlight

    The Healey center is at the front of ALS research and care, earning acclaim from patients, doctors and scientists. Still, the complexities of the disease and of drug development have brought hard-felt losses.

    Jacob Bell • Dec. 20, 2023
  • A needle is seen piercing a cell membrane in a composite image behind an office building.
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    Photo illustration: Shaun Lucas/Industry Dive; CRISPR Therapeutics; Gregor Fischer/DPA/Newscom

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    ‘No tolerance for failure’: An oral history of the first CRISPR medicine

    A new sickle cell disease therapy developed by CRISPR Therapeutics and Vertex Pharmaceuticals is now approved in the U.S. and U.K. This is the story of how it came to be.

    Ned Pagliarulo and Shaun Lucas • Dec. 10, 2023
  • A printed copy of the 2017 Tax Cut and Jobs Act is seen lying on a desk with other papers.
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    Chip Somodevilla via Getty Images
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    Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

    U.S. tax law changes six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.

    Jonathan Gardner • Nov. 28, 2023
  • A sickle cell and normal blood cells are seen in red against a blue background in this colorized microscope image.
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    Janice Haney Carr/CDC/Sickle Cell Foundation of Georgia/AP

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    What if a CRISPR cure isn’t such an easy choice?

    Casgevy can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

    Ned Pagliarulo and Shaun Lucas • Nov. 8, 2023
  • A close up a cell with a large screen in the background displaying a injection needle.
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    Gregor Fischer/DPA/Newscom

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    A decade later, biotech’s CRISPR revolution is still going strong

    Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

    Gwendolyn Wu, Shaun Lucas and Julia Himmel • Oct. 11, 2023
  • Federal Trade Commission
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    Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
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    New antitrust merger guidelines could have chilling effect on healthcare deals

    Regulators have historically struggled to halt complex and non-traditional tie-ups. That could change with new guidelines, as the Biden administration scrutinizes healthcare M&A, antitrust experts said.

    Rebecca Pifer • July 21, 2023
  • An illustrated image of clinical development for a BioPharma Dive 2021 outlook story
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    Kendall Davis/BioPharma Dive
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    10 clinical trials to watch in the second half of 2023

    A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.

    BioPharma Dive Staff • June 28, 2023
  • Two young boys are seen posing for a photograph with a snake.
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    Permission granted by Susan and Chris Finazzo
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    ‘The luckiest of the unlucky’: A Duchenne gene therapy brings hope to families — and tests the FDA

    The FDA in June approved a treatment that patient advocates and doctors believe to be a breakthrough for a deadly disease, but hasn’t yet proven that it works. 

    Ben Fidler and Shaun Lucas • May 7, 2023
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images
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    FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency

    A yearslong regulatory battle over the hormonal shot Makena is approaching its end, with consequences for both preterm birth prevention and the agency’s authority to withdraw drugs shown to be ineffective in follow-up testing.

    Delilah Alvarado • March 6, 2023
  • An AbbVie sign is seen on the outside of a building in California.
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    Courtesy of AbbVie
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    Big pharma’s looming threat: a patent cliff of ‘tectonic magnitude’

    Many top-selling products will lose patent protection by the end of the decade, putting pressure on companies to replace lost revenue with new medicines.

    Jonathan Gardner • Feb. 21, 2023
  • An illustration of a zoom screen with four anonymous characters situated on backdrops of DNA, dollar signs, binary code, and miscellaneous microscopic figures.
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    Illustration: Xavier Lalanne-Tauzia for Industry Dive

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    A new generation of biotech leaders is emerging. Can they change how drug startups are built?

    Through social media, virtual meetings and mentorship programs, a community of entrepreneurs is looking for new ways to build drug companies.

    Gwendolyn Wu • Feb. 14, 2023
  • An illustrated image of clinical development for a BioPharma Dive 2021 outlook story
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    Kendall Davis/BioPharma Dive
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    10 clinical trials to watch in the first half of 2023

    Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s, while a pair of high-priced acquisitions could be put to the test.

    BioPharma Dive staff • Jan. 3, 2023
  • A person sits for a portrait in a room with windows in the background.
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    Photo: Will Warasila for Industry Dive

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    For ALS patients, doctors, a new medicine reignites concerns about healthcare access

    Relyvrio, a drug developed by Amylyx Pharmaceuticals, is in high demand in ALS clinics across the U.S. Though some patients are already getting it, insurance coverage and out-of-pocket costs remain a source of anxiety.

    Jacob Bell and Shaun Lucas • Dec. 15, 2022
  • A picture of the street sign stating "Wall Street." American flags drape over a nearby building
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    Kena Betancur via Getty Images
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    Health tech companies weigh funding options amid weak IPO market

    Healthcare technology companies are delaying initial share sales and searching for new sources of cash. Experts don’t expect a quick recovery.

    Sydney Halleman • Nov. 21, 2022
  • A person sits on the edge of a couch looking out a window in a living room setting.
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    Photo: Amanda Greene for Industry Dive

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    ‘I don’t feel safe.’ Abortion bans add new uncertainty to fertility treatment

    BioPharma Dive’s Delilah Alvarado worked with reporters from Healthcare Dive to examine the impact of state laws banning abortion on people trying to conceive via in vitro fertilization.

    Sydney Halleman, Delilah Alvarado, Shaun Lucas and Jasmine Ye Han • Oct. 24, 2022
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    Jeff J Mitchell via Getty Images
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    Can biosimilars, after years of limited impact, finally make a mark in the US?

    Seven years after the first copycat biologic drug arrived in the U.S., expected cost savings have been modest at best. The next few years will show whether the knockoff drugs can live up to their cut-price promise.

    Jonathan Gardner • Sept. 7, 2022
  • A double exposure image of a glass flask in a laboratory with stock market information in the background.
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    MadamLead via Getty Images
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    ‘Flat is the new up’: After biotech correction, venture investors turn to safer bets

    New companies are being built more carefully and platform technologies are less in vouge as the downturn's effects ripple through the private sector.

    Ben Fidler • July 26, 2022
  • An illustrated image of clinical development for a BioPharma Dive 2021 outlook story
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    Kendall Davis/BioPharma Dive
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    10 clinical trials to watch in the second half of 2022

    The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump endures.

    Ben Fidler, Ned Pagliarulo and Jacob Bell • July 5, 2022