BIOTECHNOLOGY INNOVATION ORGANIZATION

FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Pandemic Preparedness ---Pediatric Priority Review Voucher ---Reauthorization of PAHPA ---Vaccine Access & Compensation

Antitrust Legislation ---General ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights ---Reasonable Pricing Clause Compulsory Licensing Data Privacy ---BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act of 2025 ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2276: ETHIC Act ---S.2658: Medication Affordability and Patient Integrity Act ---Dept of Commerce Patent Valuation Fee Proposal ---FTC Orange Book Delisting Initiative ---Patent Tax/fees ---PTO Proposed Rules on Terminal Disclaimer Practice ---Prohibiting Adversarial Patents Act (PAPA) Foreign Drug Data Protection Law ---BIOSECURE Act Intellectual Property Enforcement ---China Patent Reform ---H.R.3160/S.1553: PREVAIL Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---Prohibiting Adversarial Patents Act (PAPA) Patenting of Biological Inventions ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization

FY 2026 Appropriations for Agencies ---ASPR ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---Creating Hope Reauthorization Act ---Drug Pricing ---Funding for Strategic National Stockpile ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---PPRV ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of PAHPA ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.6166: Lowering Drug Costs for American Families Act ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---BIOSECURE Act ---House GOP RFI on Supply Chain ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2026 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---State Strategic Stockpile Act ---Synthetic Nucleic Acid Synthesis Screening ---VICP Loopholes ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Preserve Access to Affordable Generics and Biosimilars Act ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---BIOSECURE Act ---Clinical Trial Data in China Drug Evaluation and Review ---FDA Hiring Flexibility ---PDUFA VIII Negotiations ---Promising Pathway Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Contract Manufacturing Ecosystem in the United States ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---A bill to address patent thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biologics Competition Act ---Biosimilar Red Tape Elimination Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Medicare Drug Price Negotiation Act ---Medicare Negotiation and Competitive Licensing Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---National Coverage Determination ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---BIOSECURE Act Generic Drug Entry ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---The Medicaid VBPs for Patients (MVP) Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2026 National Security ---BIOSECURE Act ---Clinical Trial Data in China ---Most Favored Nation Pricing Opioid Crisis ---SUPPORT Act Orphan Drug Issues ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Lower Costs, More Transparency Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Protected Classes ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---Access to Innovative Treatments Act ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

FY 2026 Appropriations for Specific Issues ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Pandemic Preparedness -R&D Funding for Medical Countermeasures Biodefense Research, Development and Procurement Issues (Non-Funding) ---Bio COMPETES (Draft) ---BIOSECURE Act ---Biosecurity Modernization and Innovation Act of 2025 ---Executive Order on Achieving Efficiency Through State and Local Preparedness ---Executive Order on Withdrawing the United States from the World Health Organization ---Gene Editing ---HHS Reorganization ---MCM PRV Program ---National Defense Authorization Act 2026 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---WHO Pandemic Preparedness Accord Pandemic Preparedness ---Drug Supply Chain Management ---MCM PRV ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues

FY 2026 Appropriations for Agencies ---ASPR ---BARDA ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Medical Countermeasures ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV Reauthorization ---Pandemic Flu ---Reauthorization of PAHPA ---VICP/CICP Antimicrobial Resistance Biodefense Research, Development and Procurement Issues ---HHS Reorganization ---MCM PRV Program CDC Reform Pandemic Preparedness ---MCM PRV Reauthorization ---R&D Funding for Medical Countermeasures

FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Pilot Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---Bio COMPETES (Draft) Drug Evaluation and Review ---FDA Hiring Flexibility Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Pricing ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Vaccine Access ---Vaccines for Children Program ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2026 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics ---SUPPORT Act Orphan Drug Issues ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Program Reauthorization Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---Administration Rebate Rule ---CMMI Authority ---Medicare Part B Physician-Administered Products ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Banking Policy Impacting Emerging Companies Capital Formation Incentives ---Accredited Investor Definition Review Act ---Adjusting the well-known seasoned issuers definition to allow for a larger financing round using ---American Innovation Act ---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window ---Expanding Access to Capital Act ---Helping Startups Continue to Grow Act ---Small Entity Update Act ---To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards ---Update public float threshold triggers to align with current market conditions Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program ---Implementation of the SBIR and STTR Extension Act ---Reauthorization of SBIR and STTR

FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives Orphan Drug Issues ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act ---Cameron's Law Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---Expensing of R&D Expenditures ---Tax Incentives for Contract Manufacturing Ecosystem Vaccines and Infectious Disease ---Countermeasure Injury Compensation Fund Amendment Act ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act

CFIUS and Foreign Investment Drug Importation Drug Pricing ---Most Favored Nation - CMMI Models ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations Foreign Drug Data Protection Laws ---China Biotechnology Regulations ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes. Intellectual Property International Enforcement ---China Synthetic Biotech Tariffs Trade Relations ---Bilateral Trade Negotiations ---Section 232 ---US-China IP Provisions ---Word Health Organization (WHO) - WHO Pandemic Preparedness Accord