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Another busy week begins with BIO’s new survey of member views on tariffs and a BIO Board member’s congressional testimony on how legislation can help small biotechs. (747 words, 3 minutes, 44 seconds) |
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BIO statement on the resignation of Dr. Peter Marks from the FDA |
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John F. Crowley, BIO President & CEO, released a statement on the resignation of Dr. Peter Marks from the FDA:
“Under the extraordinary leadership of Dr. Peter Marks, the FDA shepherded in a new era of scientific breakthroughs—from new vaccines to curative cell and gene therapies that have strengthened and saved the lives of millions of patients and families,” according to Crowley.
Read the full statement.
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Tariffs threaten innovation, access to cures, say BIO members |
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U.S. tariffs on imports could increase the cost of biotech operations, threatening innovation that helps patients, according to a survey of some BIO members.
Why it matters: Nearly 90% of U.S. biotech companies rely on imported components for at least half of their FDA-approved products, and they say tariffs would hurt business. President Trump said he will unveil a tariff plan Wednesday.
The survey finds tariffs would: - Reduce access to affordable medicines: 94% of biotech firms anticipate surging manufacturing costs from tariffs on the EU. Tariffs on Canada and China would have a similar impact. The U.S. currently lacks adequate domestic manufacturing capacity.
- Stall medical innovation: Proposed tariffs on the EU would force 50% of companies to find new research and manufacturing partners, complicating regulatory filings and jeopardizing innovation.
- Create red tape: Faced with tariffs, 80% of biotech firms report needing at least 12 months to find alternative suppliers, with 44% needing more than two years.
- Complicate efforts to obtain investment: “More than 50% of biotech firms predict ‘increased difficulty’ in funding and conducting research if EU tariffs are enacted.”
BIO’s view: “This survey demonstrates the far-reaching and potentially damaging impacts of the proposed tariffs on our biotechnology industry,” says BIO President & CEO John F. Crowley. “We fully support strong policies and programs that incentivize the manufacture of medicines here in America,” he adds, promoting “reonshoring,” but warning: “It will take years, though, for this shift and we need to be mindful of the negative consequences of these proposed tariffs,” Read more on Bio.News. |
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Laws should help small biotechs gain capital, BIO Board Member tells House |
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Appropriate legislation can help innovative biotech firms working on future treatments to build capital, BIO Board Member Bill Newell testified in Congress last week.
The hearing: “Beyond Silicon Valley: Expanding Access to Capital Across America,” last Tuesday at the House Financial Services Committee, explored challenges facing small biotechs.
Why it matters: “Most biotechs remain pre-revenue through their entire time in the lab and the clinic,” said Newell, Senior Business Advisor and former CEO at Sutro Biopharma. “Deloitte reported that for 2022-23, the average R&D cost to progress a new pharmaceutical from discovery to launch is $2.3 billion.”
Legislative solutions highlighted by Newell include: - The Equal Opportunity for All Investors Act, sponsored by Rep. Mike Flood (R-NE), would open a new path for private investors seeking accreditation.
- The Emerging Growth Company (EGC) designation, which allows public companies to reduce costly Securities and Exchange Commission (SEC) reporting burdens, should be extended from 5 to 10 years.
- SEC reporting requirements cost more when a firm’s public float exceeds the threshold. The Empowering Main Street in America Act, sponsored by Sen. Tim Scott (R-SC), prevents a “temporary blip in their stock price” from triggering these requirements.
The bottom line: “Ensuring a robust domestic biotechnology industry is rightfully recognized as a critical national security issue. In addition, it is also an economic juggernaut,” Newell explained. “Drug discovery is expensive. Scientists are expensive. Clinical trials are expensive. That’s why access to capital is so crucial.” Read more on Bio.News. |
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Exciting News for BIO Members!
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BIO is thrilled to announce our new partnership with SU Group, designed to help members reduce lab equipment service costs and simplify contract management. With exclusive savings on equipment service agreements, members enjoy cost control, convenience, and flexibility. Benefit from consolidating multiple service contracts into one, guaranteed discounts with financial caps, and streamlined maintenance through proactive monitoring. Take control of your lab operations and budget with this innovative cost-savings program.
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What Else to Read This Week |
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BIO’s delegation to Tokyo builds on fruitful cooperation. The U.S. and Japanese biotechnology sectors have a longstanding and dynamic partnership, and BIO’s recent delegation to Tokyo further strengthened it. This first Japanese mission for BIO President & CEO John F. Crowley added a new feature: a Patient Advocacy Roundtable. Read more on Bio.News.
Autoimmune Awareness Month highlights diseases impacting 50M in the U.S. From encouraging research advancements to improving diagnosis and treatment, awareness creates a better future for those living with autoimmune diseases. Autoimmune Association, which wrote a guest post for Bio.News, supports policy reforms that improve access to care, including reform of prior authorization and step therapy, and offers tools and resources for patients and advocates.
The Delaware BioScience Association released a comprehensive series of policy recommendations to accelerate the growth of the state’s thriving life science industry. “Our recommendations start with a range of initiatives to spark more groundbreaking research and partnerships between our research universities and institutes and business,” writes Michael Fleming, President of the Delaware BioScience Association, in the Delaware Business Times. “We’ve also identified ways Delaware can better leverage its unique combination of collaboration and adaptability to foster productive workforce partnerships between industry, government, and educational institutions.” Delaware BioScience Association is a member of the Council of State Bioscience Associations (CSBA).
Awareness of Part D reforms grows, but familiarity remains limited, finds a national poll by the PAN Foundation’s Center for Patient Research and The Harris Poll. In January 2025, important changes took effect for the roughly 53 million seniors enrolled in Medicare prescription drug plans. These included capping total out-of-pocket prescription drug costs, including copays and coinsurance, at $2,000 per year and allowing patients to spread these costs out over the year. Patients must enroll to take advantage of the program to spread out their out-of-pocket costs over time, making awareness of the program paramount. |
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