The Latest

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    Adeline Kon/BioPharma Dive
    Deep Dive

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

    At $43 billion, Pfizer’s planned buyout of Seagen is the largest pharmaceutical industry acquisition since 2019.

    Updated March 13, 2023
  • Karuna’s schizophrenia drug success draws a royalty buyer

    PureTech Health will sell some of its royalty interest in Karuna’s drug, known as KarXT, after its second successful late-phase trial this week.

  • A view of Moderna headquarters on May 08, 2020 in Cambridge, Massachusetts.
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    Maddie Meyer via Getty Images

    Moderna inks second genetic medicine deal in a month

    The biotech plans to use Generation Bio’s nonviral delivery technology to get nucleic acid-based therapies to immune cells and into the liver.

  • Colonies of Candida albican from a urine sample are seen on a agar media plate.
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    Md Saiful Islam Khan via Getty Images

    FDA approves new antifungal as concerns grow over drug-resistant fungus

    Rezzayo is the first new treatment for candidemia and invasive candidiasis to win FDA approval in years.

    FDA
  • Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders waving a report as he questions Moderna CEO Stéphane Bancel at a March, 22, 2023 hearing.
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    Chip Somodevilla via Getty Images

    Moderna CEO defends price of COVID shot at Senate hearing

    Stéphane Bancel said his company's planned quadrupling of the vaccine’s price covers the higher costs of commercial sales. Sen. Bernie Sanders called it part of industry’s “unprecedented level of corporate greed.”

  • A thumbnail illustration for BioPharma Dive's IPO tracker
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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.

    The pace of biotech IPOs so far this year is the slowest in at least five years, lagging behind even last year's torpid clip. Only four drugmakers have priced new stock offerings.

    Updated March 3, 2023
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    Permission granted by Biohaven

    Biohaven strikes a deal to take TYK2 drugs in a new direction

    The rebooted biotech plans to test whether blocking TYK2 in the brain could help treat neurological diseases, licensing a compound from China-based Hangzhou Highlightll Pharmaceutical.

  • An illustration of a tumor suppressor protein being tagged for degradation.
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    selvanegra via Getty Images
    Emerging biotech

    At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders

    Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells.

  • A picture of Xavier Becerra giving a speech at a podium
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    Alex Wong via Getty Images

    U.S. government again rejects call to seize Xtandi rights

    The Biden administration plans to review federal “march-in” rights and consider whether price could be a reason to take control of patents for drugs developed with government funding.

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    Novo Nordisk

    Novo partners with Dewpoint to mine an emerging field for new drugs

    The companies will collaborate to identify compounds that could treat insulin resistance by targeting shape-shifting cellular droplets known as biomolecular condensates.

  • The Federal Trade Commission headquarters is pictured in Washington, D.C. The agency's proposed noncompete ban may face legal challenges on several grounds.
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    RiverNorthPhotography via Getty Images

    FTC wades into dispute between Supernus, generic competitor

    The agency, which is taking a closer look at the pharma industry, submitted a brief to federal court in a case it says could have “significant implications” for Parkinson’s patients.

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    Justin Sullivan via Getty Images

    A biotech stumbles in its bid to challenge Novo’s obesity drug

    Altimmune’s drug aided weight loss in a Phase 2 trial, but also came with side effects that could hamper its ability to compete with Novo Nordisk’s Wegovy. 

  • A sign showing Gilead's logo
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    Justin Sullivan via Getty Images

    Gilead’s Yescarta extends survival in lymphoma study

    The results, the first for a CAR-T therapy, are further evidence supporting the use of the complex therapies earlier in a patient’s disease course. 

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    sudok1 via Getty Images

    Karuna’s schizophrenia drug succeeds in a second late-stage trial

    The results add to a growing body of evidence that Karuna’s drug, known as KarXT, could be a valuable new option for patients living with the brain disorder.

    Updated March 20, 2023
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    Thomas Lohnes via Getty Images

    Flush with cash, BioNTech buys into an immunotherapy to rival Yervoy

    The COVID-19 vaccine maker is paying $200 million to secure rights to an experimental CTLA-4 inhibitor that privately held OncoC4 designed to have fewer side effects.

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    Sarah Silbiger via Getty Images
    ALS drug development

    FDA staff signal support for Biogen ALS drug, but highlight data hurdles

    In documents released Monday, agency staff appeared inclined to approve Biogen’s tofersen, which failed in its main trial. Gathering confirmatory evidence of its benefit could be difficult, however.

    Updated March 20, 2023
    FDA
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    Courtesy of Grail

    Illumina, facing Icahn challenge, ‘moving quickly’ on resolution for Grail

    The DNA-sequencing company said the activist investor hasn’t offered any better solutions for satisfying regulators’ concerns about the acquisition.

  • A photo of Takeda president of R&D Andy Plump.
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    Permission granted by Takeda

    Takeda, chasing Bristol Myers, unveils awaited TYK2 drug data

    "This is why we did the deal," said Takeda R&D chief Andy Plump, referring to his company's $4 billion acquisition of the medicine from startup Nimbus Therapeutics.

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

    FDA reversal sets up high-stakes hearing on Sarepta gene therapy

    The regulator will convene a panel of advisers to consult on an approval decision for the biotech’s Duchenne treatment, a change from just a few weeks ago when Sarepta had said a meeting wouldn’t be held.

  • A wall showing a Merck & Co. logo in Kenilworth, New Jersey
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    Courtesy of Merck & Co.

    Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

    The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo.

  • A person holds an insulin pen
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    agrobacter via Getty Images

    Sanofi joins other diabetes drugmakers in cutting insulin prices

    The pharma is the last of the three major insulin suppliers to reduce U.S. list prices, responding to persistent criticism and policy changes that will affect Medicaid rebate payments.

  • 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

    CMS lays out plans for negotiating drug prices

    The guidance fills in details for one of the central pharmaceutical provisions of the Inflation Reduction Act, signaling how the agency will use its new authority.

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    Leonid Sorokin via Getty Images

    Esperion in dispute with Daiichi over drug milestone payment

    The companies disagree over what qualifies for a payment of up to $300 million that’s associated with inclusion of heart data on the cholesterol drug’s label.

  • HHS Secretary Xavier Becerra speaks to reporters.
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    Justin Sullivan/Staff via Getty Images

    US names first drugs to face price hike penalty

    Gilead’s cancer cell therapies Yescarta and Tecartus were among the slate of 27 drugs singled out by CMS for rebates under a provision of the IRA.

  • A security guard at Silicon Valley Bank peers through the front door of the bank branch
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    Justin Sullivan / Staff via Getty Images

    Healthcare companies may turn to big banks after SVB’s fall

    SVB’s unraveling created a hole in life sciences financing that could be filled by bigger banks, but might hamper access to quick, short-term cash for startups.