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The FDA approved Merck’s vaccine against pneumococcus bacteria, and a former White House official explains why current Medicare policy will harm access to Alzheimer’s treatments. We’re off tomorrow for Juneteenth—which is also World Sickle Cell Day. We explore biotech’s role in reducing inequities that remain. (648 words, 3 minutes, 14 seconds)
We're off Wednesday, June 19, for Juneteenth. We'll return to the regular publishing schedule on Thursday, June 20.
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FDA approves Merck’s vaccine against pneumococcus bacteria |
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The U.S. Food and Drug Administration (FDA) approved Merck’s CAPVAXIVE™ vaccine to protect adults from bacteria that can cause pneumonia and invasive pneumococcal disease (IPD).
Why it matters: Over 150,000 adults are hospitalized from pneumococcal pneumonia each year in the U.S. Invasive pneumococcal disease (IPD) can present as pneumonia, sepsis, and meningitis.
Broader protection: The 21 serotypes of pneumococcus bacteria (streptococcus pneumoniae) targeted by this vaccine—including eight serotypes not addressed by previous vaccines—cause 84% of cases of IPD in adults over 50, Merck said.
What’s next: A Centers for Disease Control and Prevention advisory panel is scheduled to meet on June 27 to discuss whether the vaccine should be recommended. |
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What to know on World Sickle Cell Day and Juneteenth |
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Tomorrow, June 19, is World Sickle Cell Day and Juneteenth—a day for both celebration, and reflection on the work still needed to be done.
In December 2023, the FDA approved the first cell-based gene therapies for sickle cell disease: Casgevy by Vertex Pharmaceuticals and Lyfgenia by bluebird bio.
Why we’re talking about it right now: Sickle cell disease has a disproportionate impact on people of African descent, and it was long under-researched. Juneteenth is a day to commemorate the end of slavery, but also to recognize the inequities Black Americans still face, especially in medical research.
That began to change in 2019—when the FDA approved Global Blood Therapeutics’ Oxbryta, the first drug to treat the underlying cause of sickle cell disease. BIO Chair Dr. Ted W. Love led the company at the time.
What they’re saying: “Just seeing how the patients had very few options, and quite frankly how they were treated in the hospitals, I felt that it was an indignity, and I felt it was really a moral imperative for someone to try to do something about it,” said Dr. Love of his crusade against the disease.
But there’s still work to be done—especially around clinical trial diversity and ensuring clinical trials are representative of the patients living with a disease.
Learn more: A new film, presented by BIO member Vertex Pharmaceuticals and produced for BIO by BBC StoryWorks Commercial Productions, tells the story of a patient and his daughter, who has the most severe form of sickle cell disease—and what Vertex is doing to change the course of the disease. Click to watch: |
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‘Access to new Alzheimer’s treatments bogged down by Medicare policy’ |
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Medicare coverage needs to catch up with the latest advances in Alzheimer's treatment, researcher and former White House official Joe Grogan writes in the Chicago Tribune.
Why we’re talking about it: An FDA panel last week recommended approval of donanemab for early-stage Alzheimer’s.
“Unfortunately, it's not clear how quickly patients and their families will be able to benefit,” Grogan writes. “These drugs work best at early stages of this progressive disease. Patients who could see results from treatment today may not be eligible tomorrow.”
“The tool used to nullify these drugs is ‘coverage with evidence development,’ or CED. This program was designed to speed new technologies to market, protect patients and spur innovation. But CMS (Centers for Medicare and Medicaid Services) has warped its purpose, using CED to impede access,” Grogan writes. "Let's hope a swift FDA approval is followed by a new CMS policy that helps ensure people who need these treatments can get them.” .
Read the whole thing at the Chicago Tribune. |
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President Biden’s Tuesday: Hosting an event to celebrate the 12th anniversary of Deferred Action for Childhood Arrivals after announcing a similar action for spouses, NBC reports.
What’s Happening on Capitol Hill: The Senate Committee on Homeland Security and Government Affairs will hold a hearing on the “origins of COVID-19.” |
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