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Industry Voices: Biosimilars and Trade Secrets
Trade secrets may potentially be used to protect manufacturing processes for biological drugs--yet there is concern that the new law on biosimilars, the BPCIA (Biologics Price Competition and Innovation Act of 2009), and the accompanying FDA regulations, may expose trade secrets of both originators and biosimilar applicants.
Trade secrets may potentially be used to protect manufacturing processes for biological drugs--yet there is concern that the new law on biosimilars, the BPCIA (Biologics Price Competition and Innovation Act of 2009), and the accompanying FDA regulations, may expose trade secrets of both originators and biosimilar applicants.
Manufacturing processes for biologics include many aspects that could be kept as trade secrets, including precise cell growth conditions, analytical processes, purification process and even characteristics of the cells that produce the drug.
Source: FierceBiotech
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Despite Record ACA Enrollment, Report Reveals Underinsured Americans Are in Crisis
November 21st 2024Despite significant progress in expanding health insurance coverage since the Affordable Care Act (ACA) was enacted, millions of Americans still face critical gaps in access to and affordability of health care.
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Bridging the Vaccination Gap: Insights on Global Immunization Challenges
July 30th 2024On this episode of Managed Care Cast, we speak with Jeffery A. Goad, PharmD, MPH, 2024-2025 president of the National Foundation for Infectious Diseases, on the recent report from the World Health Organization and UNICEF on public immunization rates, with national and global health implications.
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Double Trouble: High-Deductible Plans Raise Maternity Care Costs Across 2 Calendar Years
June 27th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the June 2024 issue of The American Journal of Managed Care® about how annual high-deductible insurance plans increase maternity care costs when pregnancies cross 2 calendar years.
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Support and Skepticism Emerge as Reactions to Robert F. Kennedy Jr’s HHS Nomination
November 15th 2024In the hours after President-elect Donald J. Trump tapped Robert F. Kennedy Jr to lead HHS, reactions came swiftly to the controversial pick who would have a large influence to shake up public health.
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