The Latest

  • 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 here.

    Intellectual property is the foundation of the drug industry’s business model. This database will track key patent expiry dates for 30 top-selling medicines.

    Updated May 13, 2024
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    Phynart Studio via Getty Images
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    Sponsored by Pearson

    Acknowledging comorbidities in trial design is essential for successful outcomes

    Examine why adaptive trials that consider comorbidities are critical for a successful trial outcome.

  • An AbbVie sign is seen on the outside of a building in California.
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    Courtesy of AbbVie
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    Biosimilars are gaining ground. The IRA could push them further next year.

    As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.

  • A photo of Sanofi headquarters in Paris, France.
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    Courtesy of Sanofi
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    Sanofi gambles $80M on Fulcrum’s muscular dystrophy drug

    The deal gives the pharma partial rights to a medicine GSK once developed for heart disease but could soon become the first therapy for facioscapulohumeral muscular dystrophy.

  • A sign with the logo for the Takeda pharmaceutical company.
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    Stock via Getty Images
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    Takeda targets ‘efficiency’ in restructuring, pipeline cuts

    Among the pipeline changes is a decision by Takeda to terminate studies in blood cancer of TAK-007, a CAR-NK therapy, and to pivot instead to autoimmune conditions.

    Updated May 10, 2024
  • A composite image of two headshots, featuring Maze CEO Jason Coloma and CMO Harold Bernstein.
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    Permission granted by Maze Therapeutics
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    Maze lands new partner for Pompe drug, after Sanofi pact came apart

    An alliance with Shionogi involves similar terms as a deal Sanofi canceled in response to an unusual challenge from the Federal Trade Commission.

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    Carsten Koall via Getty Images
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    Novavax gets a lifeline with Sanofi vaccine pact

    Sanofi will ally with the under-pressure biotech, paying $500 million upfront for rights to co-commercialize Novavax’s COVID shot and develop combination influenza vaccines.

  • An illustration for BioPharma Dive's deals database
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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.

    Mariana Oncology’s sale to Novartis is the latest acquisition in a $9 billion deal streak involving developers of radiopharmaceutical drugs for cancer.

    Updated May 2, 2024
  • The Moderna headquarters is seen on November 30, 2020 in Cambridge, Massachusetts.
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    Maddie Meyer via Getty Images
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    RSV vaccines

    FDA delays decision on Moderna RSV vaccine

    The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.

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    Daniel Tadevosyan via Getty Images
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    News roundup

    iTeos shares jump on TIGIT update; Acelyrin swaps CEOs

    Interim data surpassed expectations, iTeos said. Elsewhere, Acelyrin revealed chief executive officer Shao-Lee Lin is departing and Bluebird bio gave a fuller account of its gene therapy launches.

  • A photo of Sanofi headquarters in Paris, France.
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    Courtesy of Sanofi
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    Royalty Pharma pays startup $525M for stake in Sanofi MS drug

    The deal gives the company milestone payments and royalties to a medicine, frexalimab, that Sanofi licensed from biotech ImmuNext and expects to be a future blockbuster.

  • White flags bearing Novo Nordisk's logo are seen against a blue sky.
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    Courtesy of Novo Nordisk
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    Obesity drugs

    Novo taps another Flagship startup in search for next obesity drugs

    The deal with Metaphore Biotechnologies is the third from a Flagship alliance meant to boost the Danish drugmaker’s pipeline of weight loss medicines.

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    libre de droit via Getty Images
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    Regeneron gene therapy improves hearing in two children

    The results add to an early but growing body of evidence suggesting gene therapy may improve outcomes in young kids with a genetic form of deafness. 

    Updated May 8, 2024
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    Sean Gallup via Getty Images
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    AstraZeneca withdraws COVID-19 vaccine, citing declining demand

    The move ends a turbulent saga for AstraZeneca, which successfully developed a coronavirus shot but struggled to sell it amid competition and the emergence of rare but serious side effects. 

  • A sign for Pfizer is seen outside the Pfizer headquarters on November 9, 2020 in New York City.
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    David Dee Delgado via Getty Images
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    Patient dies in Pfizer study of Duchenne gene therapy

    Pfizer said the patient, a young boy who was treated earlier last year, died suddenly from cardiac arrest. The company is working with trial researchers to investigate further.

    Updated May 8, 2024
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell / BioPharma Dive
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    New Alzheimer's drugs

    FDA sets date for advisory meeting on Lilly’s closely watched Alzheimer’s drug

    After delaying an approval decision for Lilly’s donanemab, the agency now intends to hold an advisory committee meeting on June 10.

  • A photo of Sekar Kathiresan, CEO of Verve Therapeutics
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    Seth Babin/BioPharma Dive
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    Gene editing

    Verve moves forward with backup base editing therapy

    Weeks after a safety setback derailed its lead candidate, the company has treated the first participant in a trial of its heart disease treatment Verve-102.

  • Scientists working in Prologue Medicines' laboratory.
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    Permission granted by Prologue Medicines
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    Emerging biotech

    Prologue, Flagship’s newest startup, looks to mine viruses for new drugs

    The company is using what it claims is the largest database of viral protein structures to unearth medicines for a range of diseases, said CEO and Flagship origination partner Lovisa Afzelius.

  • An illustration of B cells producing antibodies
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    Love Employee via Getty Images
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    Zenas, with new funding, aims dual-targeting antibody at lupus and MS

    The $200 million round is the latest evidence that surging interest in autoimmune disease cell therapies could expand to include developers of bispecific antibodies.

  • A Bluebird bio employee works at a laboratory.
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    Permission granted by Bluebird bio
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    Bluebird, Vertex prep for first commercial use of sickle cell gene therapies

    One patient has started the treatment process for Bluebird's Lyfgenia, while five others have done the same for Vertex's Casgevy.

    Updated May 7, 2024
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    Mohammed Haneefa Nizamudeen via Getty Images
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    Gossamer sells rights to drug it hopes can rival a new Merck therapy

    One analyst thinks the collaboration “bodes well” for Gossamer, which has had trouble convincing investors its drug seralutinib can compete on the market.

  • Corporate logos are seen outside  on May 15, 2006, in Macclesfield, England.
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    Christopher Furlong via Getty Images
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    AstraZeneca ups stake in Cellectis in latest cell therapy bet

    The British drugmaker, which has made genetic medicine a larger priority of late, added $140 million to a deal to develop up to 10 gene and cell therapies.

  • Robert Califf
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    Anna Moneymaker via Getty Images
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    As drug shortages reach record highs, regulators weigh next steps

    With many chemotherapy and ADHD drugs stuck in stubbornly short supply, several agencies are looking for new solutions.

  • A sign reading Novartis is seen on the side of a building viewed through trees.
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    Novartis
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    Why selling to Novartis made sense for Mariana

    Conversations at this year's J.P. Morgan Healthcare Conference led to a $1 billion buyout that Mariana's CEO described as a "perfect marriage."

  • Large letters spelling Amgen are seen by a wall
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    Mario Tama via Getty Images
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    Obesity drugs

    Amgen shares soar as executives outline obesity drug push

    The company said data for its Wegovy competitor was promising enough to move the drug into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.

  • The staff of CG Oncology rings the opening bell at Nasdaq as confetti falls.
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    Permission granted by Nasdaq, Inc.
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    CG follows big IPO with new results for bladder cancer drug

    Newly disclosed Phase 3 results presented Friday match findings the biotech disclosed last year, while offering a more comprehensive look at how its drug stacks up to rival therapies.