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Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, the landscape of the pharmaceutical and biotech industries is marked by groundbreaking scientific advancements, regulatory shifts, and strategic collaborations that promise to reshape patient care and drug development significantly.A controversy has emerged in the wake of proposed changes to U.S. vaccine regulations by Dr. Vinay Prasad, a senior FDA official. This proposal has sparked considerable opposition from 12 former FDA commissioners who argue that these regulatory overhauls could potentially undermine public trust in vaccines. Former leaders from both the CDC and FDA have expressed concerns over these proposed vaccine policy changes during an ACIP meeting, discussions that could influence future public health strategies and vaccine trust. At a time when vaccine confidence is crucial, maintaining the integrity of regulatory processes is vital to public health efforts.Leadership changes are also afoot within the FDA, as Dr. Tracy Beth Hoeg steps into the role of acting director for the Center for Drug Evaluation and Research. Her appointment signals a shift towards leaders with direct experience in public health crises. This comes amidst further internal restructuring at the FDA, including the transfer of Theresa Michele, long-standing director of the Office of Nonprescription Drugs, indicating dynamic changes within the agency.In the realm of oncology, Eli Lilly's progress with its Bruton's tyrosine kinase inhibitor, Jaypirca, is noteworthy. The drug's expanded label now includes earlier treatment stages for chronic lymphocytic leukemia and small lymphocytic lymphoma. This expansion underscores the therapeutic potential of non-covalent BTK inhibitors and may significantly improve patient outcomes by offering earlier intervention options.Geopolitical challenges are impacting the industry as WuXi AppTec, a major China-based biopharmaceutical contractor, faces scrutiny from the Pentagon amid concerns about its potential ties with the Chinese military. This development highlights the complex interplay between global security concerns and international biotech collaborations. The intersection of global security concerns continues to impact biopharmaceutical supply chains as WuXi AppTec faces increased scrutiny from U.S. authorities.On the manufacturing front, Quvara Medical's emergence as a new contract development and manufacturing organization following Buckland Group's acquisition of a Becton Dickinson facility in the UK reflects industry trends toward consolidating manufacturing capabilities to meet growing biopharmaceutical demand efficiently.AstraZeneca is enhancing its pipeline through a renewed partnership with Neurimmune for an amyloidosis asset. This collaboration, potentially worth up to $780 million, highlights AstraZeneca's strategic focus on rare diseases and underscores their commitment to expanding their therapeutic portfolio through successful alliances.Regulatory updates from the FDA propose reductions in user fees for early-stage clinical trials conducted domestically while considering additional fees for overseas developments. This initiative aims to incentivize research activities within the U.S., potentially accelerating drug discovery timelines and fostering domestic innovation.In surgical technology advancements, Medtronic's Hugo surgical robot has secured FDA clearance for procedures involving prostate, kidney, and bladder removal. This marks a significant advancement in robotic-assisted surgeries and could enhance patient outcomes across approximately 230,000 surgeries annually in the U.S.As we explore more about financial maneuvers within this sector, Royalty Pharma's $275 million financing deal for Denali Therapeutics' Hunter syndrome drug reflects confidence in Denali's pipeline pendinSupport the show
In this episode, listen to Matthew S. Davids, MD, MMSc​, and Lindsey Roeker, MD, discuss BTK inhibitor resistance and how it shapes treatment choices for patients with CLL, including:Contemporary treatment paradigms for patients with CLLSafety and efficacy of current regimensMolecular testing, including when and how to test for BTK inhibitor resistanceConsidering BTK inhibitor resistance when sequencing therapy Program faculty:Matthew S. Davids, MD, MMSc​Associate Professor of Medicine​Harvard Medical School​Leader, Lymphoma Program​Dana-Farber/Harvard Cancer Center​Director of Clinical Research​Division of Lymphoma​Dana-Farber Cancer Institute​Boston, Massachusetts​​Lindsey Roeker, MD​Assistant Attending​CLL Program Director​Department of Medicine​Memorial Sloan Kettering Cancer Center​New York, New YorkResources:To review a CME-certified text activity and download slides associated with this podcast discussion, please visit the program page.
In this episode, Danielle M. Brander, MD; Deborah Stephens, DO; and Brian Hill, MD, PhD, discuss key aspects of the NCCN CLL guidelines and share strategies for applying these recommendations in your clinical practice to optimize treatment and outcomes. The greater discussion addresses:Optimal selection of therapy for treatment-naive CLL, including second-generation covalent BTK inhibitorsConsiderations in therapy selection for previously treated CLLNovel strategies for treating CLL Presenters:Danielle M. Brander, MDAssistant Professor of MedicineDivision of Hematologic Malignancies and Cellular TherapyDuke Cancer InstituteDurham, North CarolinaBrian Hill, MD, PhDDirector, Lymphoid Malignancies ProgramStaff Physician, Department of Hematology and Medical OncologyTaussig Cancer InstituteCleveland ClinicCleveland, OhioDeborah Stephens, DOAssociate ProfessorDirector of the CLL ProgramLineberger Comprehensive Cancer CenterUniversity of North CarolinaChapel Hill, North CarolinaContent based on a live and online CME program supported by educational grants from AstraZeneca; BeiGene, Ltd.; and Lilly.Link to full program including downloadable slides: https://bit.ly/49YxtSq
FDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
Listen to a soundcast of the January 19, 2023, FDA approvals of Tukysa (tucatinib) with trastuzumab for colorectal cancer and Brukinsa (zanubrutinib)Â for chronic lymphocytic leukemia or small lymphocytic lymphoma.
Can the SARS-CoV-2 spike antigen be used as a biomarker for long COVID? Find out this and more in today's PV Roundup podcast.
In this episode, John M. Burke, MD, a leading expert, and Amy Esposito, FNP-C provide expert insights on key data presented at the 2022 ASCO annual conference for CLL/SLL regarding:Updated response and safety results after 3 years of follow-up from the phase II CAPTIVATE study of ibrutinib and venetoclax in patients with previously untreated CLLUpdated response and remission rates after 4 years of follow-up from a phase II trial of obinutuzumab, ibrutinib, and venetoclax in patients with either treatment-naïve or relapsed/refractory CLLProgression free survival and safety results after 5 years of follow-up from the ELEVATE-TN phase III study of Acalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil as first-line therapy in CLLAssessments of whether racial and/or ethnic identity, and socioeconomic status are prognostic factors of survival in CLLPresenterJohn M. Burke, MDRocky Mountain Cancer CentersAurora, ColoradoModerator Amy Esposito, FNP-CNurse PractitionerRocky Mountain Cancer CenterAurora, Colorado
Marginal Zone Lymphoma CancerCare Connect Education Workshops
Waldenstrom’s Macroglobulinemia CancerCare Connect Education Workshops
Marginal Zone Lymphoma CancerCare Connect Education Workshops
Marginal Zone Lymphoma CancerCare Connect Education Workshops
Marginal Zone Lymphoma CancerCare Connect Education Workshops
Small Lymphocytic Lymphoma CancerCare Connect Education Workshops
Peripheral T-Cell Lymphoma CancerCare Connect Education Workshops
This episode covers small lymphocytic lymphoma!
Diffuse Large B-Cell Lymphoma CancerCare Connect Education Workshops
Cutaneous T-Cell Lymphoma CancerCare Connect Education Workshops
Marginal Zone Lymphoma CancerCare Connect Education Workshops
Peripheral T-Cell Lymphoma CancerCare Connect Education Workshops
Small Lymphocytic Lymphoma CancerCare Connect Education Workshops
Peripheral T-Cell Lymphoma CancerCare Connect Education Workshops
Marginal Zone Lymphoma CancerCare Connect Education Workshops
Cutaneous T-Cell Lymphoma CancerCare Connect Education Workshops
Small Lymphocytic Lymphoma CancerCare Connect Education Workshops
Diffuse Large B-Cell Lymphoma CancerCare Connect Education Workshops
Marginal Zone Lymphoma CancerCare Connect Education Workshops
Small Lymphocytic Lymphoma CancerCare Connect Education Workshops
Cutaneous T-Cell Lymphoma CancerCare Connect Education Workshops
Peripheral T-Cell Lymphoma CancerCare Connect Education Workshops
Peripheral T-Cell Lymphoma CancerCare Connect Education Workshops
Small Lymphocytic Lymphoma CancerCare Connect Education Workshops
Cutaneous T-Cell Lymphoma CancerCare Connect Education Workshops
Peripheral T-Cell Lymphoma CancerCare Connect Education Workshops
Cutaneous T-Cell Lymphoma CancerCare Connect Education Workshops
Small Lymphocytic Lymphoma CancerCare Connect Education Workshops
Small Lymphocytic Lymphoma CancerCare Connect Education Workshops
Peripheral T-Cell Lymphoma CancerCare Connect Education Workshops
Cutaneous T-Cell Lymphoma CancerCare Connect Education Workshops