FDA to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Drugs
• The FDA announced it will phase out requirements for animal testing of monoclonal antibodies and other drugs, citing the availability of "more effective, human-relevant methods" for safety evaluation.
• The initiative aims to improve drug safety, accelerate evaluation processes, reduce R&D costs, and ultimately lower drug prices by implementing AI-based computational models, humanoid models, and real-world human data.
• This regulatory shift, enabled by the bipartisan FDA Modernization Act 2.0 of 2022, represents what FDA Commissioner Marty Makary calls "a paradigm shift in drug evaluation" that could expedite development of new treatments.
GSK Launches Landmark Study to Investigate Shingles Vaccine's Potential to Reduce Dementia Risk
• British pharmaceutical company GSK is initiating a groundbreaking four-year study using data from up to 1.4 million NHS patients to determine if its Shingrix vaccine reduces dementia risk.
• Previous research suggests the shingles vaccine may lower dementia risk by up to 27%, with a Stanford Medicine study finding vaccinated Welsh adults were 20% less likely to develop dementia over seven years.
• If confirmed, this could represent a significant breakthrough in dementia prevention using an existing vaccine already administered through the NHS to adults aged 65 and older.
Engineered Skin Clinical Trial Shows Promise for Severe Burn Treatment
• A clinical trial in Melbourne is testing engineered skin for severe burns, covering at least 20% of the body, using lab-grown skin cells from patient samples.
• Early results from the trial indicate positive outcomes, with most wounds closing within two weeks and minimal early scarring observed in treated patients.
• The engineered skin, grown in hydrogel sheets, aims to reduce the need for autografts and promote vascularization, offering a potential solution for extensive burns.
• Researchers are also exploring methods to improve burn healing, such as using Botox to reduce hypertrophic scarring and cell rejuvenation to speed up graft production.
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