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FDA’s approval of Bristol Myers Squibb’s Breyanzi as the first CAR T therapy for relapsed or refractory marginal zone lymphoma underscores the therapy’s expanding leadership in B-cell malignancies, backed by compelling Phase II data

Twelve former FDA leaders have publicly challenged the agency’s proposed overhaul of vaccine approvals, sparked by an internal memo linking child deaths to COVID-19 vaccination, arguing the changes threaten evidence-based standards, weaken immunobridging practices, and risk eroding public trust.

In today’s Pharmaceutical Executive Daily, the FDA appoints Tracy Beth Høeg as acting CDER director, health systems explore new commercialization partnerships for cell and gene therapies, and Aidoc submits a breakthrough-designated multi-triage AI device for FDA approval.

The agency based its approval off results collected from the Bruin CLL-321 trial.

The agency also named a new head of its Office of Nonprescription Drugs.

A successful transition from clinical development to commercial launch in cell and gene therapy requires early, structured collaboration with health systems to address operational, financial, and workflow challenges that shape real-world patient access and therapy adoption.

In today’s Pharmaceutical Executive Daily, Regeneron launches a $150 million gene editing collaboration with Tessera Therapeutics, the FDA begins agency-wide deployment of new agentic AI tools, and a new report suggests Richard Pazdur is stepping down as director of CDER.

The claim is based on recent survey results from Nationwide.

The Lifescience Dynamics analyst discusses how GLP-1s appear to provide kidney protection in a specific, well-defined population.

The former FDA oncology chief is set to resign by the end of the month.

As patient-centric evidence continues to shape the future of drug development, challenges around increased complexity and regulatory scrutiny must be addressed.

In today’s Pharmaceutical Executive Daily, Eli Lilly reduces the price of Zepbound single-dose vials for self-pay patients, a new report claims the FDA is planning changes to its vaccine approval process following assertions of COVID vaccine–related deaths, and Korea and Australia reorient their pharma launch strategies toward broader regional market opportunities.

New data shows that China and the US dominate breast cancer clinical trial expertise while lower-income countries remain under-used. Dr Gen Li, founder and president of Phesi, analyzes the numbers and discusses how smart use of AI and clinical data can address the gap.

The collaboration will focus on the development of TSRA-196 as a treatment for Alpha-1Antirypsn Deficiency (AATD).

The agency says that the decision aims to improve employee workflow and build on its previously implemented generative AI tool Elsa.

In today’s Pharmaceutical Executive Daily, Novo Nordisk files for FDA approval of a higher-dose Wegovy injectable using a priority review voucher, the US and UK agree to eliminate tariffs on pharmaceutical products, and CMS publishes major price cuts for 15 high-cost Medicare drugs under the latest IRA negotiation round.

The price adjustment to the popular GLP-1 agonist is part of an ongoing effort to expand access to patients with obesity by making medicines more affordable.

Recent policy shifts in these two influential health technology assessment markets signal a broader regional move toward faster, more innovation-friendly access frameworks.

The agreement includes exemptions for UK-produced drugs and medical devices from Section 232 tariffs, but mandates a significant change to the UK's NICE value appraisal framework.

The agency’s decision is based on claims that the Covid vaccine was linked to the deaths of 10 children.

In the final part of this conversation, Dr. Bruce Leuchter, CEO of Neurvati Neurosciences, discusses new programs at FDA and how the neuroscience space is benefitting.

Jay Bregman, co-founder of Andel, closes out our conversation by explaining the impact government programs will have on GLP-1 coverage.

Dr. Bruce Leuchter, CEO of Neurvati Neurosciences, explains why psychedelics continues to be an area of interest.

In today’s Pharmaceutical Executive Daily, Novartis plans to eliminate 550 positions at a major Swiss site, the FDA authorizes the first gene therapy for adolescents and adults with spinal muscular atrophy, and industry experts weigh in on how next-generation CDMOs are evolving to meet rapid market change.

The company submitted the new dosage for approval based on its Phase III trial results.

The approval of AstraZeneca’s Imfinzi in combination with perioperative FLOT chemotherapy marks the first immunotherapy regimen for resectable gastric and gastroesophageal junction cancers, delivering a 22% overall survival benefit and establishing a new standard of care.

The Trump administration has announced new negotiated Medicare prices for a second wave of blockbuster treatments, yielding an estimated $12 billion in savings for 2027, when compared to Medicare’s 2024 net spending.

Dr. Bruce Leuchter, CEO of Neurvati Neurosciences, continues his conversation, this time looking to the upcoming year in neuroscience.