G2G Bio Bulletin – February 21, 2026
Funding Opportunity
- The Congressionally Directed Medical Research Programs (CDMRP) has released pre-announcements for the FY 26 Spinal Cord Injury, ALS, Arthritis, Ovarian Cancer, Pancreatic Cancer and Tick-Borne Disease Research Programs.
- New ARPA-H Program: Critical Illness Immunological Reprogramming and Control Point Learning Engine (CIRCLE). Highlights:
- Aims to develop digital twin capabilities to treat critical illness using the latest in AI and diagnostics. The aim is to determine immune system control points that can enable better use of existing immunotherapies, as well as next-generation interventions.
- Upcoming Deadlines: Proposer’s Day - March 11, Solution Summary Due: March 30
Updates from Washington
Congress: There was limited activity, as both the House and Senate were on recess this past week. Highlights include:
- FDA Modernization Proposal: Senator Bill Cassidy (R-LA), Chair of the Senate Health Education Labor & Pensions (HELP) Committee issued a report with recommendations to accelerate delivery of regulated products to patients faster and to maintain American dominance in the biomedical sciences. The document was devised with input from relevant stakeholders, and Chair Cassidy intends to convene a bipartisan process around these proposals. Key recommendations are a mix of undertakings at both an agency and legislative level and include:
- Targeted use of AI to expedite review at key junctures
- Reducing barriers to market entry for generics, and streamlined pathways for new biologics and biosimilars.
- Wider use of digital health technologies, in the context of decentralized clinical trials
- Expansion of the ‘least burdensome’ approach, to improve consistency between different regulatory teams
- Support for the Human Foods Program to address chronic disease
- Strengthening the FDA workforce, through cross HHS partnerships and external fellowships
- Generic Drug Supply Chains: Senators Rick Scott (R-FL) and Kirsten Gillibrand (D-NY), the Chair and Ranking Member, respectively, of the Senate Special Committee on Aging, have written to Secretary Hegseth requesting information on efforts to identify and address vulnerabilities in America’s pharmaceutical supply chain that may threaten military readiness and national security. This follows four hearings by this Committee on this topic and related matters.
Administration & Agencies:
- FDA:
- The agency has agreed to review Moderna’s mRNA flu vaccine, reversing course after significant backlash to last week’s decision to decline review
- Dr. Tracy Beth Høeg, the Director of CDER has indicated that two of her top priorities are evaluating the safety of antidepressants used by women during pregnancy and of monoclonal antibodies administered to infants to protect against RSV
- Dr. Rick Abramson, who currently is advisor to FDA, and formerly a medical AI company executive, has been appointed to lead FDA’s Digital Health Center of Excellence.
- CDC:
- NIH Director Jay Bhattacharya will take charge of CDC on interim basis, following the departure of former acting Director Jim O’Neill last week, who will be the nominee to lead the NSF
- The Advisory Committee on Immunization Practices (ACIP), has postponed its forthcoming meeting from next week, to mid-March
- CMS
- Administrator Dr. Mehmet Oz, has pledged to continue insurance coverage for recommended vaccinations, and emphasized that CMS will pay for vaccines on the new schedule for children
- Dr. Oz has reaffirmed the Administration’s stance that Congress needs to codify the Administration’s actions on most favored nation (MFN) drug pricing, while also noting that any legislation would need to account for the needs of industry, in order to continue to support innovation
- White House, Other HHS Divisions & Departments:
- Small Business Administration (SBA): The agency has directed federal awarding entities, to review their set-aside policies and small, disadvantaged program awards