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    Adeline Kon/BioPharma Dive
    Deep Dive

    After a record run, fewer biotechs are going public. Here’s how they’re performing.

    Prime Medicine became the first gene editing company to seek an IPO in 2022 and could be the first to go public since Caribou Biosciences last July. 

    Updated Sept. 26, 2022
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    Permission granted by Salesforce.com
    Sponsored by Salesforce

    What biopharma companies can do to avoid a consumer communication crisis

    Every challenge is also an opportunity. And these challenges offer biopharma companies an opportunity to improve communications in a way that also helps improve overall health.

  • A picture of the exterior of the US Department of Health and Human Services. In front of the building is a black sign designating the building's name.
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    Alex Wong via Getty Images

    Federal watchdog highlights flaws in speedy FDA approvals

    A newly published report by the HHS inspector general found that a substantial number of drugs given an accelerated approval by the FDA still haven’t proven whether they help patients.

    FDA
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    Novartis

    Supreme Court grants Novartis request to halt Gilenya patent cancellation

    The Swiss company said it would suffer irreparable harm if generics for the multiple sclerosis drug were allowed to enter the market before the higher court reviews the merits of its case.

  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta

    Sarepta asks FDA to approve first gene therapy for Duchenne muscular dystrophy

    The application comes a year earlier than previously had been expected, as company says drug reviewers are open to accelerated review based on data from early-stage trials.

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    Permission granted by Ventus Therapeutics

    Ventus sells its lead drug candidate to Novo Nordisk

    The biotech will part with its lead drug candidate, an anti-inflammatory small molecule, in Novo Nordisk’s bet on inflammasome treatments.

  • An illustration for BioPharma Dive's deals database
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    Adeline Kon/BioPharma Dive
    Deep Dive

    Biotech M&A is picking back up. Here are the latest deals.

    Rocket Pharmaceuticals’ acquisition of Renovacor is the 12th biotech company buyout valued over $50 million so far this quarter and part of a pickup in dealmaking activity. 

    Updated Sept. 20, 2022
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    koto_feja via Getty Images

    Biohaven’s ALS drug comes up short in Mass General trial

    Run by the hospital’s Healey Center, the platform trial is designed to evaluate several prospective treatments simultaneously and get answers on their potential more quickly.

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    alvarez via Getty Images
    Emerging biotech

    Sudo joins a wave of startups taking aim at Bristol Myers’ new skin disease drug

    The startup, which emerged Wednesday with $37 million in funding, is the latest company trying to top Bristol Myers’ TYK2 inhibitor Sotyktu.

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    Mario Tama via Getty Images

    J&J’s consumer health spinout to be named Kenvue

    The planned split is a major shakeup for the world’s largest drugmaker and one of the most familiar corporate brands. The new company will sell well-known products like Tylenol and Band-Aids.

  • Beta-Amyloid Plaques and Tau in the Brain
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    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.

    In surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial

    The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s.

    Updated Sept. 27, 2022
  • A photo of Vertex Pharmaceuticals' Boston headquarters.
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    Courtesy of Vertex Pharmaceuticals

    Vertex given green light to seek US approval of CRISPR-based therapy

    The company and its development partner, CRISPR Therapeutics, will begin submitting a rolling application in November. The blood disease treatment is the first of its kind to near an FDA review. 

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    Permission granted by Ethan Perlstein and Klein Lab at UCSF
    Q&A // Emerging biotech

    Perlara CEO Ethan Perlstein on reviving a biotech and building a ‘Y Combinator of rare diseases’

    The CEO resuscitated the sector’s first public benefit corporation during the pandemic, building an unusually transparent model for biotechs. Now, he’s spun out a startup and is planning for more.

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    Peddalanka Ramesh Babu via Getty Images

    Roche pays $70M in another bid to catch up on cancer cell therapies

    Rival companies have set a standard in lymphoma and leukemia. Now the Swiss drugmaker wants to be a pioneer in cell treatments for solid tumors.

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    Courtesy of Scribe Therapeutics

    Sanofi partners with Scribe to gain gene editing tools for cell therapy work

    The California biotech will receive $25 million upfront from Sanofi, which plans to use Scribe’s platform to edit natural killer cells for cancer treatment.

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    Biogen to pay $900M to settle lawsuit over MS drug outreach

    A former Biogen employee sued in 2012, alleging the company paid physician fees to encourage prescribing of its drugs. Biogen did not admit wrongdoing as part of the settlement.

  • A photograph of Prime Medicine CEO Keith Gottesdiener
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    Permission granted by Prime Medicine
    Emerging biotech

    Prime Medicine becomes the next high-profile biotech to test IPO waters

    The startup, which launched last year with $315 million in funding and plans to advance a new form of gene editing, is one of the first big venture-backed biotechs in several months to seek an IPO.

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    Warren Little via Getty Images

    GSK names Julie Brown, former Burberry executive, its first female CFO

    The U.K. drugmaker now also stands to become the first big pharmaceutical company to have women in its top two roles, with the transition planned for May 2023.

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    Permission granted by Seagen

    Seagen, amid deal rumors, spends $50M on a dual-targeting cancer drug

    While a long-rumored acquisition by Merck & Co. still hasn’t materialized, Seagen is forging ahead with a deal of its own, grabbing rights to a bispecific antibody drug from Lava Therapeutics. 

  • Packaging for a pediatric formulation of Pfizer and BioNTech's COVID-19 vaccine
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    Courtesy of Pfizer

    Pfizer, BioNTech seek FDA clearance for updated COVID-19 booster in children

    The request, if cleared, would make U.S. kids between 5 through 11 eligible to receive a "bivalent" shot targeting components of the omicron variants currently circulating. 

  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images

    FDA advisers back microbiota-based treatment for gut infection

    Committee members voted in support of Rebiotix’s treatment for recurrent C. diff infections of the intestines, a condition with no approved options after antibiotics fail.

    Updated Sept. 23, 2022
    FDA
  • Senators Patty Murray, D-WA and Richard Burr, R-NC, at a meeting of the Senate HELP Committee
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    Joe Raedle / Getty via Getty Images

    FDA user fee package to be included in bill to fund government, avoid shutdown, senators say

    A “practically clean” version of the bill will allow the FDA to continue its review and testing programs, while leaving more ambitious goals to be dealt with in a funding bill later this year.

    FDA
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    Jolygon via Getty Images

    AstraZeneca gives up on Ionis’ RNA drug for heart disease

    The British drugmaker decided the medicine, which works similarly to Novartis’s Leqvio, wasn’t potent enough to justify further testing. 

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    ismagilov via Getty Images

    Pfizer, Sangamo set to resume gene therapy study after safety delay

    Concerns over blood clotting risk had derailed testing of the hemophilia treatment last year, leading the companies to adjust their trial protocol.

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    Md Saiful Islam Khan via Getty Images

    GSK buys into Spero’s comeback plan

    The British drugmaker is investing in Spero Therapeutics and acquiring most of the rights to an oral antibiotic the FDA previously rejected, but could approve if it succeeds in a new Phase 3 trial.

  • Lilly drug wins FDA clearance for gene-mutated solid tumors, regardless of type

    The approval is another example of so-called tissue-agnostic indications, which are based on a cancer’s genetic signature rather than where it is in the body.

    FDA