In a controversial decision, FDA announced today that it had approved Biogen’s Alzheimer's drug, aducanumab.
“We ultimately decided to the use the Accelerated Approval pathway — a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit,” said the prepared statement from Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research.
An advisory committee of outside experts had voted against recommending approval. Clinical trial results for the drug have been mixed, and at one point the company shelved the drug before re-analyzing trial results and restarting the process for gaining FDA approval.
Bridging the Diversity Gap in Rare Disease Clinical Trials with Harsha Rajasimha of IndoUSrare
November 8th 2023Briana Contreras, an editor with Managed Healthcare Executive, spoke with Harsha Rajasimha, MD, founder and executive chairman of IndoUSrare, in this month's episode of Tuning in to the C-Suite podcast. The conversation was about how the disparity in diversity and ethnicity in rare disease clinical trials in the U.S. has led to gaps in understanding diseases and conditions, jeopardizing universal health, and increasing the economic burden of healthcare.
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Managing Editor of Managed Healthcare Executive, Peter Wehrwein, had a discussion with William Shrank, M.D., a venture partner with Andreessen Horowitz, a venture capital firm in Menlo Park, California, about how artificial intelligence's role is improving healthcare, where we are today with value-based care and the ongoing efforts of reducing waste in the healthcare space for this episode of the "What's on Your Mind" podcast series.
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35th World AIDS Day Marks 20 Years of PEPFAR: Challenges and Strategies to Combat HIV/AIDS
November 29th 2023PEPFAR, having invested $100 billion and saved 25 million lives in the global fight against HIV/AIDS, faces Congressional hurdles in its reauthorization due to abortion debates. Despite widespread support and no evidence of abortion-related activities, the legislative process is at a standstill. Members of PEPFAR and authors of a recent editorial stress the significance of PEPFAR and advocate for integrating behavioral and social science into healthcare programs to achieve UNAIDS targets and address barriers in HIV/AIDS testing and treatment.
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