EPA, FDA and USDA Issues Updates to the Joint Regulatory Plan for Biotechnology

Contact Information: EPA Press Office (press@epa.gov) Source: https://www.epa.gov/newsreleases/epa-fda-and-usda-issues-updates-joint-regulatory-plan-biotechnology WASHINGTON – Today, May 8, 2024, in response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration and the U.S. Department of Agriculture have developed a plan to update, streamline…

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Reshaping the narrative on biopharma innovation with BIO Board Chair Dr. Ted Love

Dovetailing closely on access, advocacy, policy and innovation, BIO Board Chair and founder of Global Blood Therapeutics Dr. Ted Love discussed his mission oriented journey in the life sciences in the day’s keynote. This work continues with the need to reshape the narrative around biopharma innovation, access, cost and value. “Drug cost is not a…

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Access and Advocacy: “Share the Savings”

Americans want policymakers to see lowering out-of-pocket costs for health care as a top priority. Putting pharma and its innovators who invest billions of dollars in R&D for therapies that improve outcomes and save lives in villainous crosshairs is easy to understand and politically expedient, but misguided. In 2021, West Virginia became the first state…

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New CMS guidance a “missed opportunity” for future medical innovation, patients

June 30, 2023 | Source BIO.org The Centers for Medicare & Medicaid Services (CMS) today released its guidance for the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 (IRA). John Murphy, BIO’s Chief Policy Officer, made the following statement:  “As we have stated in the past, the Medicare price setting…

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Vital Transformations Study Regarding White House Drug Pricing and SMART Act Released

The Vital Transformations study was released this week, and it estimates that there would be more than 235 fewer FDA approvals of new medicines for patients battling cancer, neurological, and rare and infectious diseases over the next decade as well as 15,714 lost jobs for Georgia workers if proposals to expand federal government-mandated drug pricing policies are…

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A Patients Perspective of Clinical Trial Benefits

Dorothy Leone-Glasser, RN, HHC, CEO Advocates for Responsible Care, Chair Ga Bio Patient Advocacy Alliance Clinical trials are essential for the development of new treatments for chronic illness patients. Every new medicine and treatment started with volunteers participating in clinical trials. Our current high standards of medical care and newly discovered therapies have improved the…

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The Value of Support Groups

Dorothy Leone-Glasser, RN, HHC, CEO Advocates for Responsible Care, Chair Georgia Bio Patient Advocacy Alliance When I was diagnosed with systemic lupus erythematosus at 19 years, I discovered a major void in the treatment of chronic illness –support counseling to help patients understand and cope with the challenges of their disease. To bridge this gap…

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Michelle Kimberly Clark’s Story

Michelle Kimberly Clark Breast Cancer Survivor, Clinical Trials Patient Participant In May of 2013, while exercising Michelle felt a small mass on her left breast. In 2015, she met Andre (her husband), starting her life as a young, vibrant, African American woman. They moved to Atlanta and as Michelle states, she was “on her way to…

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