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Pink Sheet Podcasts

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

Pink Sheet Podcast: Adcoms Too Emotional, Pushing Gene Therapy Science, Congress Gets UFA Update

Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.

Pink Sheet Podcast: Cell Therapy Enforcement Discretion Ends, Inspection Normalcy, FDA Hiring Boom

Pink Sheet reporters and editors discuss the end of stem cell clinic enforcement discretion, the US FDA’s projection that inspections will return to normal levels in FY 2022, and improved hiring in CDER.

Pink Sheet Podcast: Emergent On Capitol Hill, Second Cures Bill, US FDA’s Public Sponsor Rebuke

Pink Sheet reporters and editors discuss Emergent BioSolutions’ congressional appearance, plans for the next 21st Century Cures bill, and the FDA’s statement on the clinical trials for CytoDyn’s investigational COVID-19 therapy.

Pink Sheet Podcast: COVID Vaccine In Adolescents, CMS Drug Pricing Moves, Standard Care In Clinical Trials

Pink Sheet reporters and editors discuss the US FDA decision to lower the eligibility age for the Pfizer/BioNTech COVID-19 vaccine, CMS drug pricing project plans, and mid-stream standard of care changes in drug development.

Pink Sheet Podcast: COVID-19 Vaccine IP Waivers, Pandemic Delayed Inspections, CAR-T Reimbursement

Pink Sheet reporters and editors discuss the potential for the US and other governments to waive IP protections for COVID-19 vaccines, the FDA’s inspection backlog during the pandemic, and potential reimbursement changes for CAR-T therapies.

Pink Sheet Podcast: US FDA Accelerated Approval Adcomm, Drug Pricing, COVID-19 Help For India

Pink Sheet reporters and editors discuss the three-day US FDA advisory committee review of several oncology accelerated approvals, President Biden’s speech to Congress and its impact on drug pricing legislation, as well as the implications of the US helping India battle its COVID-19 surge.

Pink Sheet Podcast: COVID-19 Vaccine Blood Clots, Virtual Inspection Guidance, New CDER Director

Pink Sheet reporters and editors discuss the response to the rare blood clots seen with Janssen’s COVID-19 vaccine, the US FDA’s new virtual facility inspection guidance, and the new permanent director of the Center for Drug Evaluation and Research.

Pink Sheet Podcast: EUA’s Impact On US FDA, March-In Rights, CBER And Real-Time Oncology Review

Pink Sheet reporters and editor discuss the influence of the emergency use authorization on FDA decisions, another twist in the march-in rights debate, and how CBER is not using the real-time oncology review program.

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Informa Pharma Intelligence podcasts discuss key ideas and insights affecting biopharma and medtech, brought to you by our global team of editors. Listen on-demand to our perspectives on the latest industry developments.

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