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Trump’s psychedelics push a mixed blessing for neuropsychiatric companies, patients

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With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?

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Andelyn Partners with S. Korea-Based ENCell to Accelerate Global Delivery of Gene Therapies

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Andelyn Biosciences and ENCell, both CDMOs, signed a collaboration agreement to create a strategic manufacturing bridge between the United States and Asia-Pacific (APAC) regions to accelerate the global delivery of gene therapies.

The partnership leverages both companies’ GMP manufacturing facilities, technical expertise, and regional networks to fast-track the development, manufacturing, and global expansion of client programs, according to officials at both organizations.

This partnership is designed to enable a streamlined “dual hemisphere” workflow. By providing a direct route between U.S. and APAC manufacturing hubs, the collaboration could help remove a number of the regulatory and logistical complexities of international expansion.

Most importantly, facilitating in-country manufacturing for in-country clinical trials ensures regional supply chains can meet the specific needs of local patient populations, greatly reducing lead times and accelerating the path to commercialization, pointed out Wade Macedone, CEO at Andelyn.

“Our partnership with ENCell is a powerful step forward in Andelyn’s mission to help bring life-saving therapies to patients worldwide,” he said. By joining forces with such a respected leader in South Korea, we are not just expanding our global footprint; we are leveraging our unique strengths to deliver a truly seamless international manufacturing network.”

“This partnership with Andelyn represents a significant step in expanding the global CGT ecosystem,” added Jong Wook Chang, PhD, CEO of ENCell. “By combining Andelyn’s expertise in viral vector development and cGMP manufacturing with ENCell’s clinical and manufacturing capabilities across APAC, we are establishing a seamless manufacturing platform connecting the United States and Asia-Pacific.

“Together, we will enable more efficient development and scalable production of gene therapies, supporting our clients from early-stage development through global clinical trials and commercialization.”

The post Andelyn Partners with S. Korea-Based ENCell to Accelerate Global Delivery of Gene Therapies appeared first on GEN – Genetic Engineering and Biotechnology News.

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BridgeBio’s oncology spinoff swaps out CEOs as it seeks to accelerate KRAS work

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BridgeBio Oncology Therapeutics is replacing CEO Eli Wallace, putting its CSO Pedro Beltran in the role, and making board member Neil Kumar executive chairman.

The changes come as there’s been growing competition in cancer over …

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Live: Robert F. Kennedy Jr. testifies before Senate HELP committee

Health secretary Robert F. Kennedy Jr. will testify Wednesday before the Senate lawmakers who arguably hold the most power in advancing or hindering his Make America Healthy Again agenda. 

The Senate Health, Education, Labor, and Pensions Committee hearing will also put the secretary face-to-face with Chair Bill Cassidy (R-La.), whose vote to confirm Kennedy last year came with a number of promises on vaccine policy that Kennedy has since blown through.

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Health secretary Robert F. Kennedy Jr. will testify Wednesday before the Senate lawmakers who arguably hold the most power in advancing or hindering his Make America Healthy Again agenda. 

The Senate Health, Education, Labor, and Pensions Committee hearing will also put the secretary face-to-face with Chair Bill Cassidy (R-La.), whose vote to confirm Kennedy last year came with a number of promises on vaccine policy that Kennedy has since blown through.

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