The Latest

  • 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.

    Mineralys Therapeutics, the developer of a blood pressure drug licensed from Mitsubishi, will try on Thursday to become the second biotech in a week to raise at least $100 million in an IPO.

    Updated Feb. 7, 2023
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    libre de droit via Getty Images

    Bayer begins key tests for closely watched blood thinner

    The company has begun enrolling patients in one of the largest Phase 3 programs in its history, a pair of trials that will test an anticoagulant it believes can be a future blockbuster.

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    Courtesy of Roche

    Roche rival to AstraZeneca’s Soliris succeeds in late-stage testing

    The company said the experimental injection matched Soliris in a Phase 3 study and would soon be submitted to regulators around the world.

  • Vials of Eisai and Biogen's new Alzheimer's drug Leqembi
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    Courtesy of Leqembi

    Eisai gives first glimpse into Alzheimer’s drug launch

    In the month since its U.S. approval, Leqembi has had its first sale, its first prescription written and its first administration to a patient.

  • Astellas' U.S. headquarters in Northbrook, IL.
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    Permission granted by Astellas

    Astellas switches CEOs amid plans to pursue ‘aggressive’ growth

    Naoki Okamura, currently Astellas’ chief strategy officer, will replace current CEO Kenji Yasukawa as the company attempts to “further accelerate growth.”

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    Adeline Kon/BioPharma Dive
    Deep Dive

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

    Four of the past five biotech acquisitions have featured contingent value rights agreements, suggesting a mismatch between buyers and sellers over what companies are worth.

    Updated Jan. 26, 2023
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    Mario Tama via Getty Images

    J&J says drug it acquired from Momenta succeeds in study of ultra-rare condition

    Results from a small, mid-stage study of nipocalimab showed promise in treating an autoimmune disorder affecting fetuses and newborns, J&J said.

  • Idorsia shares sink on ‘unexpected’ failure of drug study

    The Actelion spinout’s drug clazosentan, which is approved for use in Japan, didn’t significantly outperform a placebo in a Phase 3 study of patients with a particular type of stroke.

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    Justin Sullivan via Getty Images

    FDA approves Gilead’s Trodelvy for expanded use in breast cancer

    The agency’s OK is a win for Gilead, which has bet big on the drug. But the company will face tough competition from AstraZeneca and Daiichi Sankyo’s fast-selling Enhertu.

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    Courtesy of Roche

    Roche writes off $3B on lower sales forecasts for gene therapies, cancer drugs

    Among the drugs Roche recorded impairment charges on are four gene therapies acquired in the company's 2019 deal for Spark Therapeutics. 

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    Pixelimage via Getty Images

    Magenta to explore sale, merger after study setback

    The biotech recently stopped a trial of its experimental conditioning regimen over safety concerns. Now it’s halting further development work as it undertakes a strategic review.

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    gorodenkoff via Getty Images

    COVID-19 vaccine maker Medicago to close down

    The company, which worked with GSK to develop a coronavirus shot, is ceasing operations after its corporate parent cut off further investment. 

  • Lilly reports fast sales for new diabetes drug

    Still, fourth quarter sales for Mounjaro were slightly below high Wall Street forecasts and didn’t offset falling revenue from Lilly’s COVID-19 antibodies. 

    Updated Feb. 2, 2023
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    Kendall Davis/BioPharma Dive
    Deep Dive

    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.

  • Roche executive Teresa Graham
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    Roche promotes from within to replace pharma head

    Teresa Graham, currently head of Roche Pharmaceuticals’ global product strategy, will succeed former chief Bill Anderson. The reshuffle is one of several recent changes in the pharma’s leadership. 

  • A 3D illustration of the hepatitis B virus.
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    iStock via Getty Images

    GSK moves hepatitis B drug into late-stage testing

    The British drugmaker sees potential for the medicine to be a functional cure for chronic infections, and is beginning two Phase 3 trials to test its promise. 

  • A backlit Karuna Therapeutics sign on a teal wall sits behind a white marble reception desk
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    Permission granted by Karuna Therapeutics

    Karuna, hoping to find new brain drugs, buys up a shuttering biotech’s pipeline

    Though Goldfinch Bio focused on kidney diseases, Karuna believes its experimental drugs may have potential treating psychiatric and neurological conditions.

  • A photo of a sign showing the Food and Drug Administration logo
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    Sarah Silbiger via Getty Images

    FDA to convene advisers on review of RSV vaccines from GSK, Pfizer

    The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.

    Updated Feb. 2, 2023
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    Courtesy of GSK

    GSK secures FDA approval of anemia drug, but with limitations

    The approval is a win for GSK as the FDA had previously rejected two similar drugs from Akebia Therapeutics and Fibrogen. But it comes with restrictions on its use and a safety warning.

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    Alvarez via Getty Images

    3 more biotechs announce layoffs as industry cost-cutting continues

    Evelo Biosciences, Quince Therapeutics and Inovio are the latest to pare down workforces in the face of clinical setbacks and depressed stock prices.

  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
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    Sarah Silbiger/Getty Images via Getty Images

    Head of FDA gene therapy office set to retire in March

    Wilson Bryan, a key decision maker in the agency’s oversight of genetic medicines, is expected to leave next month amid an organizational revamp of his office, the FDA confirmed.

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    Novartis confirms it has stopped development of experimental Huntington’s drug

    Termination of the branaplam program, according to Novartis, was due to an “overall assessment of the risk-benefit profile” observed in a mid-stage clinical trial that raised safety concerns last year.

  • A close up of the Pfizer BioNTech vaccine on December 23, 2021 in Poole, England.
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    Finbarr Webster via Getty Images

    Pfizer forecasts steep decline in COVID vaccine, drug sales

    Yearly revenue from Comirnaty and Paxlovid could fall by nearly two thirds in 2023 amid lower vaccination rates and a shift to private market sales.

  • Portrait of Boro Dropulić, chief executive officer of Vector BioMed.
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    Permission granted by Vector BioMed

    A startup launches with plans to open up a gene and cell therapy bottleneck

    The pipeline of CAR-T therapies and ex vivo gene therapies has swelled in recent years, but manufacturing hasn’t been able to keep up with demand.

  • A prescription bottle with white pills and a wooden gavel sit atop a $100 bill showing Benjamin Franklin's face.
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    Bill Oxford via Getty Images

    Court rules for drugmakers in 340B fight over contract pharmacies

    The decision is a win for Sanofi, Novo Nordisk and AstraZeneca. The drugmakers sued HHS after regulators ordered them to stop restricting sales of 340B drugs to contract pharmacies.