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As summer comes to a close, we look at two of BIO’s big priorities when Congress returns in September. We have the facts, plus more news to know before the holiday weekend. (735 words, 3 minutes, 40 seconds)
We’ll take a quick break for Labor Day, and resume publication on Monday, September 8. |
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BIO’s congressional priorities for September session: PPRV and SBIR |
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When Congress returns in September, BIO’s immediate legislative priorities are reauthorization of the Pediatric Priority Review Voucher (PPRV) and the SBIR/STTR seed-funding program.
Why it matters: Patients and American biotech innovation suffer if Congress doesn’t act this fall to reauthorize these two vital programs (and continue most federal spending).
Why PPRV: 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, with the funds reinvested in other research. Renewed with bipartisan backing since its initiation in 2012, the program sunset late last year.
BIO’s view: “Patients and innovators have been relying on this program to enable treatments for rare diseases attacking children for nearly 15 years. It costs taxpayers nothing, and it’s hanging in limbo right now. Congress needs to understand the urgency and what is truly at stake,” says Aiken Hackett, BIO SVP of Federal Government Relations. “For the rare disease community, the PPRV means hope,” adds Karin Hoelzer, BIO’s Senior Director, Patient Advocacy.
More reading:BIO’s PPRV fact sheet and what experts said at BIO 2025.
Why SBIR/STTR: Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding enables the launch of innovative biotech startups. SBIR/STTR provides $4 billion for thousands of small- and medium-sized companies each year, driving 12% of all FDA-approved drugs.
BIO’s view: "For years, Congress has reauthorized the SBIR program with bipartisan support due to its proven track record of helping innovators,” says NewYorkBIO CEO Jennifer Hawks Bland, who leads the Council of State Bioscience Association's SBIR working group. “Here in New York, SBIR powers a life sciences sector that includes 117,000 bioscience jobs. For the sake of our (national) innovation economy and the patients who depend on continued progress, we urge Congress to get this done.”
In other advocacy: BIO is working to educate the Administration and Congress about the devastating impact that policies like Most Favored Nation (MFN) pricing and tariffs would have on America's economic and national security—and how these policies would disrupt our ability to develop future treatments and cures for patients across the country.
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BIO 2025: As M&A slows, data is key |
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M&A in biotech has slowed from its peak in 2023, but companies with strong, clear data can still do deals, said experts at BIO 2025 in Boston.
The trends: While 2023 was a record year for large M&A deals, the market cooled in 2024, and early 2025 values remained modest, said experts. Still, the second half of the year looks likely to improve, said Janet Raimondo, Head of Transactions at Novartis.
Show your numbers: “For us, uncertainty is not what’s influencing how we approach deals. We’ve already completed several,” Raimondo stressed. “In the end, it’s all about the strength of the data.”
Make it clear: “Everyone thinks they have the best data, but it won’t work if no one understands it,” said Dan P. Moore, Partner, Collected Strategies. The value of a company’s science must be clear to potential partners.
What about VC? While M&A activity is slow, venture capital for new biotech companies is slower, according to BIO’s recent report, “The State of Emerging Biotech Companies: Investment, Deal, and Pipeline Trends.”
The bottom line: “We do know that companies are reducing their pipelines. We do know that companies are laying off individuals. We do know that companies are having a challenge raising funds,” said Chad Wessel, BIO’s Director of Industry Analysis. Read more on Bio.News. |
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Novo Nordisk’s Wegovy granted FDA accelerated approval for treating liver condition. Already approved for controlling obesity and reducing the risk of major cardiovascular events, the GLP-1 is now approved for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, Novo Nordisk announced.
Step therapy significantly worsens psoriasis and other serious diseases. Far from being a simple cosmetic condition, psoriasis is an immune-mediated, systemic, inflammatory disease that can cause reduced mobility, and increase the risk of cardiovascular disease, metabolic disorders, and other long-term health impacts. Psoriasis patients are particularly impacted by the harms of step therapy. The National Psoriasis Foundation (NPF) spoke to Bio.News about the disease, the power of patient advocates, and common-sense fixes that would reduce the harm of step therapy to patients.
Pediatricians’ group diverges from CDC in calling for COVID vaccine for young children. In their first major deviation from Centers for Disease Control and Prevention (CDC) recommendations in 30 years, the American Academy of Pediatrics (AAP) strongly recommends COVID-19 shots for children ages 6 months to 2 years, a high-risk group, AP reports. “The CDC no longer recommends routine vaccination for healthy children,” says the APA. “In contrast, the AAP recommends all young children ages 6-23 months get vaccinated as well as children ages 2-18 years in certain risk groups.” |
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While congressional recess runs through Sept. 1, BIO continues engaging with both Congress and the Administration on issues that matter to biotech. |
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