mailitics

Category: Moderna

  • STAT+: Moderna to pay Roivant up to $2.25 billion to settle patent lawsuit behind mRNA vaccines

    STAT+: Moderna to pay Roivant up to $2.25 billion to settle patent lawsuit behind mRNA vaccines Moderna has agreed to pay Roivant up to $2.25 billion to settle claims that the mRNA vaccine developer infringed on Roivant’s patents in its Covid-19 shot. Roivant will receive $950 million and then another $1.3 billion if Moderna’s attempts…

  • Hims’ Super Bowl fallout, and the FDA reverses course

    Hims’ Super Bowl fallout, and the FDA reverses course Was Hims’ Super Bowl ad the final straw for regulators? Is the bar being lowered for psychedelic medicines? And what’s happening behind-the-scenes with Moderna and the Food and Drug Administration? We discuss all that on this week’s episode of “The Readout LOUD.” STAT’s Katie Palmer joins…

  • STAT+: FDA’s rejection of Moderna threatens to stifle broader vaccine industry

    STAT+: FDA’s rejection of Moderna threatens to stifle broader vaccine industry The Food and Drug Administration’s refusal to review Moderna’s flu vaccine this month has renewed fears that Trump administration policies could paralyze the vaccine industry, dissuading companies from developing new shots in the U.S. and leaving the country flat-footed in the event of future…

  • STAT+: FDA refuses to review Moderna’s influenza vaccine

    STAT+: FDA refuses to review Moderna’s influenza vaccine The Food and Drug Administration refused to review Moderna’s application for a new influenza vaccine, the company said Tuesday, a surprise decision that could  raise concerns about the agency’s posture toward drug companies and the Trump administration’s policies on vaccines. Moderna, revealing the rejection, took the unusual…

  • BridgeBio’s great week and Moderna’s unraveling

    BridgeBio’s great week and Moderna’s unraveling Has BridgeBio’s business model worked? How are executives at Moderna dealing with the company’s slump? And who will the hosts dress up as for Halloween? We discuss all that on this week’s episode of the “The Readout LOUD,” STAT’s biotech podcast. We bring on BridgeBio CEO Neil Kumar to…

  • STAT+: Moderna says key study of its CMV vaccine, expected to be its next big win, failed

    STAT+: Moderna says key study of its CMV vaccine, expected to be its next big win, failed Moderna said Wednesday afternoon that its experimental vaccine for cytomegalovirus, a cause of disability in newborns, failed in a Phase 3 trial, a significant setback for a company already facing pressure from Wall Street and the federal government.…

  • FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility

    FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility Moderna’s Covid-19 vaccine for children has been given full Food and Drug Administration approval, making it the first Covid vaccine for kids in the United States that will no longer be administered under an emergency use authorization.  But the approval comes with…

  • Moderna’s vaccine hit, the MAHA report, and an ASCO preview

    Moderna’s vaccine hit, the MAHA report, and an ASCO preview What does the MAHA Commission have planned for the drug industry? Why is Robert F. Kennedy Jr. targeting mRNA vaccines? And what are Adam and Elaine getting up to in Chicago? We discuss all that and more on this week’s episode of “The Readout LOUD,”…

  • How do we know mRNA vaccines are safe and effective? An explainer

    How do we know mRNA vaccines are safe and effective? An explainer Messenger RNA vaccines fueled the response to the worst pandemic the world has faced in a century and led to a Nobel Prize. This week, they’re set to face intense scrutiny from critics doubtful of the safety and efficacy of these shots. On…

  • STAT+: Vertex reports an earnings miss and pause on cystic fibrosis trial

    STAT+: Vertex reports an earnings miss and pause on cystic fibrosis trial Vertex Pharmaceuticals on Monday reported disappointing first-quarter earnings impacted by weaker-than-expected sales of its drugs for cystic fibrosis, and little or no contributions from a gene therapy for sickle cell disease and a recently launched pain medicine.  A “tolerability issue” caused a temporary…