A New Direction For Alzheimer’s R&D: FDA Outlines Early Disease Pathway
Alzheimer’s R&D has suffered multiple failures over the last decade, with no drug found to slow or halt the underlying progression of the disease. Industry’s focus is now on patients at the very earliest stages of the disease, and FDA is meeting sponsors halfway, with a draft guidance outlining approval requirements.
Candid conversations with C-suite leaders.
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The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
Digital clinical trials, a trend sparked by the COVID-19 pandemic that has held the biopharma industry’s interest, are changing the way patients interact with research and improving access, says Medable’s CEO.
INFOGRAPHIC: Deal volume for both M&A and alliances fell in 2023, but average valuations rose appreciably. Antibody-drug conjugates for cancer drove high-value acquisitions and partnerships.
Introducing the all-new Citeline News and Insights app, providing seamless access to all your favorite award-winning publications. Explore the latest articles from Pink Sheet, Scrip, In Vivo, Medtech Insight, Generics Bulletin and HBW Insight, all in one stylish, intuitive and user-friendly platform.
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Launching In Vivo’s oncology therapeutic review series, this first instalment provides a data-led primer on the global cancer landscape. Future instalments will explore market dynamics, pipeline evolution and the innovations set to define oncology therapeutics through 2032.
The seventh annual edition of In Vivo’s Rising Leaders features entrepreneurs, academics, lawyers, regulators and innovators from around the globe, representing the forefront of creativity in health care.
