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BIO President & CEO John F. Crowley writes Congress to urge PPRV passage; plus a deep dive into the impact of autoimmune disease on women. (761 words, 3 minutes, 48 seconds) |
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BIO urges Congress to reauthorize PPRV |
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“It is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review Voucher Program (PPRV) is reauthorized,” BIO President & CEO John F. Crowley said in a letter to congressional leaders on Friday.
“The PPRV has become an integral part of the biotech ecosystem,” Crowley explains. Companies gaining approval for rare pediatric disease drugs can receive a voucher granting expedited review of another drug in the future; the voucher can also be sold to another company to fund research. And it doesn't cost the taxpayer any money.
Why it matters: “While treatments for rare pediatric conditions exist, options remain limited due to the high cost of development and utilization by a smaller section of the patient population. This program has proven successful, which is why it has been reauthorized with bipartisan support three times,” Crowley writes.
Why now: “There are some issues facing Congress where restraint may make sense,” he continues. “But this legislation does not need further review. In its simplest form, the Give Kids a Chance Act is a life-saving measure for children and families who simply cannot afford to wait any longer.”
The bottom line: “One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives,” Crowley writes. “This program will provide greater certainty to small biotech companies, but more importantly, hope to children and families living with rare diseases.”
Read and share the letter. |
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Improving women’s health by addressing autoimmune disease |
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Women’s health is under-researched and under-funded—especially when it comes to autoimmune disease. For International Women’s Day, we looked at why.
Why it matters: Autoimmune disease impacts 24 million Americans, and 80% are women. For instance, women are 10x more likely than men to develop Hashimoto’s disease, the most common cause of hypothyroidism (underactive thyroid) in the United States. Autoimmune diseases result in about $100 billion in treatment costs annually, focused on symptom management and slowing disease progression.
Why woman are more frequently impacted: The reasons for these disparities are complex, and not completely understood. Better understanding why women are disproportionately affected may hold valuable clues for a cure.
The need for action: The Society for Women’s Health Research (SWHR) policy agenda targets improved autoimmune disease research in women. It urges policy improvements, including more research on: - the role hormonal changes play in autoimmune risk and symptom severity;
- the biological and environmental mechanisms that affect autoimmune incidence and outcomes across different racial and ethnic populations, and factors that predispose individuals to these diseases; and
- research funding to improve the knowledge base, and drive progress forward.
Read more on Bio.News. |
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What Else to Read This Week |
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“This month marks my one-year anniversary as BIO’s CEO,” said John F. Crowley in his first-anniversary letter to BIO members. “Today, we increasingly have the tools, talents, and technologies to address a range of challenges in human health, the environment, and food security—allowing us to alleviate an enormous amount of human suffering,” he said. “While threats to our fragile bio-ecosystem abound, so too do opportunities for positive and bold change.”
To meet this moment, Crowley shared that BIO is focused on "big, bold ideas" to support the industry: - "Reimagine the clinical trial paradigm and FDA review and approval processes.
- Enable capital formation for emerging biotech innovators, which are engines of growth from agriculture and energy to medicines.
- Protect and advance intellectual property rights, a cornerstone of our industry.
- Ensure a resilient and robust manufacturing supply chain in the U.S. and among allies."
Innovations in biomanufacturing are helping us build better with biology. Biobased products, made sustainably from natural raw materials instead of fossil fuels, were celebrated on Saturday’s National Biobased Products Day. BIO calls for more support for biobased products through expansion of the BioPreferred Program and development of the North American Industry Classification System (NAICS) to clearly define biobased products. Read more on Bio.News.
BIO’s Sylvia Wulf will moderate a panel on Tuesday at the World Agri-Tech Innovation Summit in San Francisco. BIO’s Interim EVP & Head of Agriculture and Environment will lead a discussion, “Breeding Innovations: Creating Value in a Highly Commoditized Food System,” exploring the development of new crops, commercialization of them, and how gene editing and breeding technologies fit into corporate pipelines. Read more. |
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The House is expected to vote soon on a continuing resolution; a proposal released Saturday “would extend current funding levels until the end of the fiscal year in late September,” per The Washington Post. The Senate Health, Education, Labor & Pensions Committee has scheduled a hearing Thursday to consider the nomination of David Weldon to be Director of the Centers for Disease Control and Prevention (CDC), while the Senate Finance Committee has a hearing scheduled for Friday to consider the nomination of Dr. Mehmet Oz to be Administrator of the Centers for Medicare and Medicaid Services (CMS). |
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