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A new study highlights the devastating impact of the Inflation Reduction Act’s drug price controls—plus, the FDA approved the second-ever RSV vaccine, bringing the total to two in one month. (480 words, 2 minutes, 24 seconds) |
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IRA means 40% reduction in new drugs over 10 years, report finds |
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Patients could lose access to at least 40% of new medicines that would have been developed over the next 10 years due to the drug price controls in the Inflation Reduction Act, says a new study. The key finding: The Inflation Reduction Act could prevent the development of as many as 139 therapies, says a study released today from Vital Transformation (with support from BIO). |
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Here’s why: The IRA empowers the Centers for Medicare and Medicaid Services (CMS) to set prices on 100 drugs over the next 10 years and impose costly penalties on manufacturers. As a result, drug manufacturers could decide they can’t afford to invest years of work and billions of dollars into R&D—and it’s already happening.
R&D drives drug development: On average, biopharma firms dedicate 39% of sales revenue to R&D, more than any other sector, the study shows.
Another unintended consequence: The IRA removes incentives for developing new orphan drugs for rare diseases, the study explains.
BIO’s take: “We are already seeing companies stop critical research because of the IRA. This analysis shows that these impacts will only grow and become more severe—harming patients desperate for treatments for cancer, orphan diseases, and other areas of unmet patient need,” says BIO Chief Policy Officer John Murphy.
Read the full report. Read our first look at Bio.News. |
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Pfizer’s RSV vaccine approved for use in adults over 60 |
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The Food and Drug Administration (FDA) approved the second RSV vaccine ever: Pfizer’s ABRYSVO, for adults over age 60. Why it matters: RSV is a highly contagious upper respiratory disease that’s especially dangerous for the oldest and youngest age groups. RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 and over.
From zero to two in one month: This is the second-ever RSV vaccine after the FDA approved GSK’s Arexvy, also for adults over 60, on May 3.
Ready for fall RSV season: The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meets June 21 to discuss recommendations for RSV vaccines for older adults. “Pending the outcome of this meeting, Pfizer anticipates supply availability in Q3 2023 ahead of the anticipated RSV season this fall,” Pfizer said.
Kids are next: With children being another high-risk group, Pfizer has already requested market approval for a maternal RSV vaccine to protect unborn infants. FDA is expected to decide on that vaccine candidate by August.
More RSV shots coming: Several other RSV immunizations are under development, reports Bio.News.
Read more about Pfizer’s RSV vaccine in Bio.News. |
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| What Are Your Cost Savings Opportunities? Find Out at BIO 2023
| Will you be at BIO 2023? Stop by Booth 143 in the BIO Pavilion to meet with BIO’s Preferred Providers and discuss how you can save on a variety of business-critical services. Leaders from HR, business insurance, regulatory services and more will be there to talk cost-effective services specific for life science companies.
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President Biden’s Thursday: Giving a commencement speech at the U.S. Air Force Academy in Colorado Springs.
What’s Happening on Capitol Hill: Having passed the House, the bill to extend the federal debt ceiling now goes to the Senate, where Majority Leader Chuck Schumer (D-NY) is anticipating work will go into the weekend to avoid hitting a potentially devastating debt deadline Monday, The Washington Post reports.
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