Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Chiesi has entered a $2.1 billion collaboration with Arbor to develop a gene therapy for primary hyperoxaluria type 1. AstraZeneca continues to invest in AI partnerships, FDA lifts clinical hold on Neurizon's ALS drug, and the cell and gene therapy field faces challenges and opportunities at the Meeting on the Mesa event. CDC adopts ACIP recommendations, FDA's manufacturing initiatives progress, and Mythic cuts staff.Industry leaders in the cell and gene therapy space are gathering in Phoenix for a meeting on the mesa, where the market is experiencing mixed signals. While M&A activity and regulatory support are showing momentum, challenges with commercialization are still hindering investor interest. The focus on next-generation multiple sclerosis treatments beyond BTK inhibitors is gaining attention, with companies like Immunic Therapeutics exploring neuroprotective targets and remyelination.The future of gene therapy depends on improving safety through targeted delivery and human-relevant testing to avoid costly failures. The FDA has released new guidance to streamline regulatory pathways for cell and gene therapies for small populations, which is receiving a warmer welcome compared to previous issuances. In other news, the US government shut down, leading to the FDA closing for new applications, while Amgen presents late-stage data for Repatha in preventing heart disease.Additionally, Metsera's obesity drug shows promising efficacy in mid-stage trials. Cybersecurity is highlighted as a crucial challenge in the pharmaceutical industry, with a focus on protecting manufacturing integrity and innovation. Upcoming events include webinars on mRNA medicine and biopharma deregulation, while job opportunities in various biopharma companies are also available.

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