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Before you jump into the pool, jump into science! We’re kicking off our inaugural Summer Science Splash, a new feature to refresh our knowledge of public health and life sciences achievements, with exciting news: a new monoclonal antibody to protect infants and a promising Alzheimer’s drug, plus a look at the progress on RSV in 2023. (734 words, 3 minutes, 40 seconds) |
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FDA approves monoclonal antibody to protect infants from RSV |
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In the latest bioscience victory over viruses, the Food and Drug Administration (FDA) yesterday gave the first approval to a monoclonal antibody to protect infants against respiratory syncytial virus (RSV).
The news: The FDA approved Beyfortus (nirsevimab-alip), developed by BIO members AstraZeneca and Sanofi, to protect newborns during their first season of RSV, a potentially life-threatening illness.
Why it matters: There is no vaccine to protect infants against RSV—yet. While vaccines enable the immune system to develop long-lasting protection, Sanofi explains monoclonal antibodies can supplement vaccination with faster direct protection. Beyfortus gives five months of protection.
What’s next: The CDC’s Advisory Committee on Immunization Practices will vote on Aug. 3 whether to include Beyfortus in the recommended immunization program for children.
Looking further ahead: Another candidate to protect newborns from RSV is Pfizer’s vaccine given to pregnant mothers to develop immunity in the fetus. Pfizer says FDA approval is anticipated next month. |
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Lilly’s Alzheimer’s treatment shows significant positive results in trial |
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Eli Lilly yesterday announced positive results from clinical trials of its candidate treatment for Alzheimer’s disease, bolstering the case for better patient access to this class of drug. The good news: Lilly’s donanemab, which targets amyloid plaque in the brain, was shown to slow cognitive decline by as much as 35% for patients with early Alzheimer’s symptoms.
A barrier: The Centers for Medicare and Medicaid Services (CMS) announced that Medicare would only cover this class of Alzheimer’s drugs if they receive traditional approval and patients participate in a registry.
What they’re saying: “The best way to permanently ensure timely and affordable access is for CMS to open a reconsideration of its [National Coverage Determination]—as it has promised to do in conjunction with new clinical evidence that is now available—and cover new Alzheimer’s medicines and diagnostics to FDA label,” said a statement from Eli Lilly.
What’s next: Traditional FDA approval could come by year’s end, Lilly said. |
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House passes Animal Drug User Fee Amendments |
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The House unanimously passed legislation yesterday to approve the regime for regulating animal drugs for the next five years.
What we’re talking about: The Animal Drug and Animal Generic Drug User Fee Amendments (ADUFA) outline the regulatory process of the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) —and the fees they charge drug makers—for approving new treatments for livestock and pets.
What we get: The user fees and CVM personnel have increased six-fold since ADUFA was established 20 years ago, though the workload has declined 12.5% and the rate of product approvals has been flat, said the Animal Health Institute (AHI).
Why it matters: Speedy approval is necessary to encourage investment in drug development, said John Torres, BIO’s Director of Federal Government Relations for Agriculture & Environment. An analysis found that the same veterinary drugs are approved more than two years earlier in Europe, according to AHI.
BIO’s take: “As the costs of animal drug R&D and drug approvals go up, we implore FDA to use these resources wisely and continue to find ways to speed up the review process, to keep animals and consumers safe while positioning the U.S. as a global leader in animal treatments,” Torres told us.
What’s next: ADUFA must be approved by the Senate, so stay tuned. |
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Protecting older Americans, protecting health systems |
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It’s no secret that as we get older, it becomes more important to keep up with recommended vaccinations, from seasonal vaccines like Influenza to age-appropriate vaccines like Shingles and Pneumococcal.
And it’s no longer just the flu season we need to worry about—but
a possible flu, COVID, AND RSV season.
Luckily, vaccines can reduce both the risk of getting more than one infection at the same time, as well as the need for hospitalization when infected—reducing the burden on overstretched hospitals in the winter.
And new this year:
RSV
vaccines, giving older Americans a three-pronged attack to keep themselves and their families healthy and safe.
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President Biden’s Tuesday: Meeting with Israeli President Isaac Herzog in the Oval Office, after offering Prime Minister Bibi Netanyahu an olive branch, per The New York Times.
What’s Happening on Capitol Hill: A House Energy and Commerce Health Subcommittee hearing, “Innovation Saves Lives: Evaluating Medicare Coverage and Pathways for Innovative Drugs, Medical Devices, and Technology,” will look at how Medicare can use more transparent coverage determinations “to create a more reliable pathway for coverage of safe and effective breakthrough treatments with the ultimate goal of providing greater predictability and stability for medical innovators, doctors, and, most importantly, patients,” says a statement. |
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