Pharma and BioTech Daily

Pharma and Biotech Daily: Navigating Uncertainties in the Industry


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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Pfizer has dropped its lead obesity molecule, danuglipron, due to safety concerns regarding liver issues, leaving the company with only one molecule in its obesity pipeline. This decision has raised questions about the future direction of Pfizer's obesity research. Additionally, there are fears about the impact of recent firings at the Department of Health and Human Services on the FDA, with concerns about delays in drug approvals and increased political influence on regulatory decisions.In other news, Verve's base editor showed promise in lowering bad cholesterol levels in a phase Ib trial, and there are ongoing legal battles between Vanda and the FDA over off-label use of a drug for jet lag. Overall, the biotech industry is facing challenges and uncertainties in light of recent developments.The FDA is facing an uncertain future following a major overhaul by Kennedy, which included staff cuts that could threaten user fees, nearly half of the FDA's budget. Drug review delays and increased executive oversight are expected, with fears mounting about the agency's future direction. AI is enabling the development of smart antibodies that can more precisely target cancer cells while sparing healthy tissues.Upcoming FDA actions include a cell-based gene therapy for a rare skin disease and product expansions for Regeneron and Sanofi. Experts are concerned that FDA layoffs could trigger a mechanism that may set the industry back 35 years. Other news includes the FDA replacing some animal testing with AI and human 'organoid' lab models, changing attitudes towards the MMR vaccine, recent approvals in colorectal cancer, and more.Readers are encouraged to provide feedback on what topics they would like to see covered next.
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