G2G Bio Bulletin – August 10, 2026
Funding Opportunities
Two new ARPA-H programs have near-term deadlines. They are:
- Restorative & health-Enhancing Sleep Time (REST): Aims to advance at-home solutions to diagnose, monitor and treat sleep problems. Solution Summary Due: August 12
- Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and Supplies (FASTPASS): Aims to build rapid, non-destructive screening tools to assess the quality of and safety of pharmaceutical shipments in near-real time. Registration for Virtual Proposers Day: August 20
G2G Highlights
Our team was in Florida last week for the 2026 Military Health System Research Symposium (MHSRS). The meeting highlighted key military medical priorities, including countermeasures against antibiotic resistance, cellular therapy for wound healing, novel TBI treatments, and next generation prosthetics technologies. Stay tuned for our conference readouts!
Updates from Washington
Congress: The Senate was in session for its final week ahead of the monthlong August recess.
- FY2027 Appropriations: The Senate voted 90-6 to pass the continuing resolution (CR) released last Sunday to fund the government until December and avert a shutdown. The CR includes a provision limiting the Administration's federal grants overhaul, and will be considered by the House when it returns from recess.
- Committee Hearings, Legislation and Other Activity:
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Nomination Votes: The Senate confirmed Dr. Erica Schwartz to be CDC Director by a vote of 51 to 44. In line with the committee vote, she garnered the support of all Republicans and Sen. Tim Kaine (D-VA).
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340B Reform: Leaders of the bipartisan Senate 340B working group unveiled legislation to overhaul the drug discount program. The bill, the SUSTAIN 340B Act includes measures to:
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Reaffirm program structure of upfront discounts and end rebate programs
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Establish the definition of eligible patients and covered services
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Codify provider use of contract pharmacies, with some limitations
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Establish auditing and reporting requirements for 340B compliance, and facilitate removal of covered entities for noncompliance and lack of remedial activity
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Standardize financial assistance policy for patients at or below 200% of the federal poverty line
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Establish a 340B data clearinghouse to prevent discount duplication or diversion of funds, paid for by a user fee program
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Authorize $15 M for oversight and enforcement over five years and $36 M for bill implementation over four years
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Pharmaceutical Supply:
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Sen. Adam Schiff (D-CA) and Sen. Rick Scott (R-FL) have introduced a bill that would require CMS to provide Congress with recommendations on how the agency can reduce reliance on foreign manufacturers for active pharmaceutical supplies and key starting materials, via its coverage and reimbursement authorities.
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Sen. Scott and Sen. Kirsten Gillibrand (D-NY) have written to acting FDA Commissioner Kyle Diamantas regarding shortages of generic cancer medications, and their concerns with agency proposals to temporarily permit importation of these drugs from overseas manufacturers that do not typically supply American markets.
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Biotechnology: The Senate Finance’s Committee’s Health Care Subcommittee convened a hearing titled 'Building a Resilient Health Care Future with Biotechnology, which featured testimony from Dr. Alan Palkowitz of the Indiana Biosciences Research Institute, Dr. Michelle Rozo of the National Security Commission on Emerging Biotechnology (NSCEB), Dr. Vera Luther of Dartmouth Hitchcock Medical Center and Kevin Outterson of the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). The two overarching themes of the hearing were:
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Antimicrobial resistance (AMR) is a significant threat to the US, and development of new antimicrobials hinges on effective economic incentives and scientific workforce development. This discussion referenced the bipartisan PASTEUR Act which would create a subscription payment model to incentivize antibiotic R&D that is otherwise uneconomical and fund programs on antibiotic stewardship and surveillance.
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Coordinated biotechnology infrastructure, expertise, and investment, to effectively translate scientific discoveries, prevent early-stage companies from getting trapped in the Valley of Death, and to reduce the growing gap between the US and China in this sector. The American Innovation and Jobs Act, which expands R&D tax credits and codifies continued R&D expense deduction, was discussed as a step in the right direction.
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Other Health-Focused Bills: The Senate unanimously passed bills to establish a National Plan for Epilepsy and to authorize or reauthorize research programs focused on ALS, Down Syndrome and tick-borne illness.
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COVID-19: The Senate Homeland Security Committee on Thursday voted 8-7 to hold Dr. Anthony Fauci in contempt of Congress, following his refusal to answer questions at the previous week's hearing. All Committee Republicans voted in favor, and all Democrats voted against. The measure will now be considered by the entire chamber.
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AI Regulation: Rep. Jay Obernolte (R-CA) and Rep. Lori Trahan (D-MA) have introduced the FRONTIER Act to strengthen oversight of advanced AI. This comes a few months after they released a discussion draft soliciting stakeholder feedback.
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Administration & Agencies:
- CMS: Several months after the initial announcement, the agency has published the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway in the Federal Register. Comments are due by October 7. The proposal would accelerate Medicare coverage of medical devices in development and/or under consideration by FDA as outlined below:
- Eligible: Presumptive Class II breakthrough devices participating in TAP planning, Class III breakthrough devices that will be part of a PMA submission regardless of TAP status, and pre-submission devices that will be subject to IDE studies enrolling Medicare beneficiaries.
- Not Eligible: Devices that fall under existing Medicare benefit categories, national coverage determinations, and/or can be separately billed to Medicare.
- FDA: Moderna’s mRNA-based flu vaccine has now been approved for adults 50 and over. The approval comes six months after the agency attempted to decline consideration of the application altogether.
- White House, Other HHS Agencies & Departments:
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Affordable Care Act: Democratic state attorneys general have filed a suit to stop implementation of the Administration's recent changes to ACA markets that were announced as part of anti-fraud efforts.
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Foreign Companies of Concern: A federal judge has issued an injunction that temporarily prevents enforcement of WuXi AppTec’s designation as a Chinese military company, under Section 1260H of the National Defense Authorization Act (NDAA)
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