Nicholas Jacobus is a content associate for Pharmaceutical Executive and can be reached at njacobus@mjhlifesciences.com.
In today's Pharmaceutical Executive Daily, a new West Health-Gallup survey finds that more than 82 million Americans have cut back on daily expenses to cover healthcare costs, the FDA expands the approved age indication for GSK's RSV vaccine Arexvy to adults aged 18 to 49 at increased risk, and a new commentary argues that agentic AI is positioned to fundamentally reshape commercial operations in life sciences.
A nationally representative survey of more than 20,000 U.S. adults found that 33% made at least one daily spending trade-off to pay for healthcare in the past year
Arexvy is now approved for adults aged 18 to 49 with underlying conditions that elevate their risk of severe RSV disease.
In today's Pharmaceutical Executive Daily, Senate Democrats press major pharmaceutical companies for transparency on the terms of their most-favored-nation pricing deals with the Trump administration, a new analysis examines the gap between the promise and the reality of Europe's Joint Clinical Assessment framework, and Eli Lilly issues a public safety warning about compounded tirzepatide products mixed with vitamin B12.
Industry experts across the biotech sector discuss the latest trends impacting emerging biotech companies, including the challenges of early-stage biotech start-ups, AI integration across the sector, and the most recent innovations in drug discovery.
Testing reveals that compounded tirzepatide products mixed with vitamin B12 contain a chemical impurity of unknown toxicity.
In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter stemming from a 2025 inspection of its U.S. headquarters, and Pharmaceutical Executive's latest analysis examines the state of the biopharma industry as it navigates a period of cautious momentum.
FDA cites systemic failures in how the company tracked and reported adverse drug events across several of its medicines, including semaglutide.
FDA issued draft guidance that would eliminate certain clinical pharmacokinetic studies from the biosimilar development process.
Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes FDA’s single-trial approval pathway may accelerate development, but manufacturers face heightened litigation risk, pricing uncertainty and safeguards.
In today's Pharmaceutical Executive Daily, the FDA approves leucovorin as the first-ever treatment for an ultra-rare genetic condition called cerebral folate transport deficiency, Enhertu receives FDA Priority Review for HER2-positive early breast cancer in the post-neoadjuvant setting, and a new commentary argues that AI has fundamentally changed how healthcare communicators must think about content strategy.
FDA approved GSK's Wellcovorin as the first treatment for cerebral folate deficiency caused by a rare genetic variant.
The application is based on Phase III trial data showing the drug reduced the risk of invasive disease recurrence or death.
Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, discusses FDA’s removal of the two-trial requirement marking a significant policy shift and prompting sponsors to consolidate into a single robust pivotal study.
In today’s Pharmaceutical Executive Daily, Vinay Prasad exits the FDA’s Center for Biologics Evaluation and Research for the second time in under a year, major deal activity including a GSK and Alfasigma licensing agreement along with Servier’s $2 billion acquisition of Day One Pharmaceuticals, and Ipsen withdraws Tazverik from the market following emerging clinical trial data.
Ipsen is withdrawing its EZH2 inhibitor Tazverik from all markets after an ongoing clinical trial identified safety concerns involving secondary blood cancers.
The GSK licensing deal is reportedly worth up to $690 million.
Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes shifting regulatory signals for Moderna’s mRNA flu vaccine review and raises broader questions about the stability of the approval pathway.
FDA informed uniQure it will not accept external control data as the primary basis for approving AMT-130, instead demanding a prospective, randomized, sham surgery-controlled trial before moving forward.
In today’s Pharmaceutical Executive Daily, Cognito Therapeutics and Nexcure secure new financing rounds to advance their pipelines, artificial intelligence and large language models reshape pharmacovigilance and drug safety monitoring, and Eli Lilly launches a new Employer Connect platform to expand obesity treatment coverage options.
Cognito Therapeutics and NexCure have each closed new funding rounds this week, advancing an at-home Alzheimer's stimulation device and a platform to bring CAR-T therapy to community settings
Eli Lilly launches Employer Connect, a new platform linking employers with benefit administrators and a pharmacy network to expand affordable access to its obesity medication Zepbound for U.S. workers.
In today’s Pharmaceutical Executive Daily, Antengene and UCB enter a billion-dollar global licensing agreement for a bispecific T-cell engager, Teva signs a $400 million strategic growth capital agreement with Blackstone Life Sciences, and industry leaders explore the technological renaissance driven by AI integration.
The agreement is focused on advancing ATG-201, a bispecific T-cell engager therapy targeting B cell-driven autoimmune diseases.
Teva Pharmaceuticals has secured $400 million from Blackstone Life Sciences to advance duvakitug, an experimental monoclonal antibody in Phase III trials for ulcerative colitis and Crohn's disease.
As AI rapidly reshapes drug development and clinical operations, industry leaders say transparency, governance, and strong data foundations will determine whether the technology accelerates innovation or stalls under regulatory and operational pressure.
In today’s Pharmaceutical Executive Daily, industry leaders examine how to measure AI’s return on investment across the life sciences value chain, Novo Nordisk commits $506 million to expand its Ireland manufacturing facility, and Bavarian Nordic CEO Paul Chaplin announces plans to step down.
Bavarian Nordic CEO Paul Chaplin will step down by the end of 2026 after overseeing the company’s transformation into a profitable global vaccine player,
Novo Nordisk is investing to expand its Athlone, Ireland facility, aiming to boost global manufacturing capacity for oral GLP-1 treatments.
In today’s Pharmaceutical Executive Daily, the FDA approves an expanded indication for Palynziq in patients aged 12 and older, Sogroya becomes the first and only weekly long-acting growth hormone approved for pediatric use, and experts examine how real-world data strengthens natural history disease research.
