Drug Fix: US FDA’s Makary Pressured To Resign, Continues Hiring, Reform Efforts

In the latest episode of HBW Insight's Over the Counter podcast, Volker Spitzer, vice-president, global R&D/RWE services at IQVIA Consumer Health, returns to examine the implications of agentic AI for the consumer health industry – a topic he and colleagues explore in a recently published white paper. Unlike the large language models now familiar to most consumers, agentic AI operates with persistent memory, cross-platform autonomy, and the ability to act on a user's behalf over time, functioning less like a search tool and more like a continuous personal health advisor. In the first of this two-part conversation, we discuss important questions, such as: Can AI systems can yet be trusted to guide health decisions reliably? What is the role of the pharmacist in this evolution of health information technology? Is the existing product-focused regulatory framework equipped to govern a technology that operates as a dynamic, personalized recommendation engine rather than a fixed promotional claim? Part two – published in two weeks’ time on HBW Insight – will address the commercial implications, including what the rise of agentic AI means for marketing strategy, industry readiness, and brand risk.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年5月8日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻: 诺和诺德抢占早期口服减肥药市场；葛兰素史克（GSK）交易强化其下游减肥药战略；辉瑞因Vyndamax和解协议前景转好； 中国主导创纪录的新药上市；以及强生公司放弃两款淋巴瘤CAR-T疗法。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-IEFP6L4BNNCFTNMAXVIX54E6CQ/

Audio roundup of selected biopharma industry content from Scrip over the business week ended May 8, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Novo winning early oral obesity market; GSK deal bolsters downstream obesity strategy; brighter Pfizer outlook due to Vyndamax settlements; China dominates record novel drug launches; and J&J drops two lymphoma CAR-Ts.   Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-IEFP6L4BNNCFTNMAXVIX54E6CQ/

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the increasing pressure on US Food and Drug Administration Commissioner Martin Makary to resign and its long-term impact on the agency (:34). They also discuss Makary’s comments on patient anecdotes influencing regulatory decisions on psychedelic drugs and his new AI-enabled one-day facility inspection program (12:14), criticism of Makary’s Commissioner’s National Priority Voucher Program (18:49), and his intent to hire 3,000 new scientists (23:12). #pharma #business More On These Topics From The Pink Sheet Psychedelic Testimonials Alone Cannot Meet Legal Approval Standard, US FDA’s Makary Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/psychedelic-testimonials-alone-cannot-meet-legal-approval-standard-us-fdas-makary-says-OCRVXBPRMJAR3I5LCSA7QER724/ US FDA Piloting AI-Enabled One-Day Inspections To Expand Oversight, Improve Efficiency: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-piloting-ai-enabled-one-day-inspections-to-expand-oversight-improve-efficiency-ULUXK3SYFVF4ZDHYTA4QWXNDJE/ US FDA Hiring 3,000 Scientists To Power Sweeping Reform Agenda, Makary Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-hiring-3000-scientists-to-power-sweeping-reform-agenda-makary-says-HCDJTHZFUFBSZL5C2DKCG7FPAE/ US FDA Limits Some Staff Performance Awards, In Part Because Funds Are Insufficient: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-limits-some-staff-performance-awards-in-part-because-funds-are-insufficient-YMV4DDERO5A5LO5AOSORPXWDGE/

BioWales Podcast: Getting Medtech Right In A Small Country Maximizing The Tailwind From BioWales 2026 Gwyn Tudor, head of the MediWales forum, lays out the challenges, opportunities and funding on offer for healthtech founders who make Wales part of their strategic plan. For healthtech companies looking to move from start-up to manufacturing and scale-up, Wales can be an attractive location, with its quality manufacturing facilities, expertise and often lower costs than in other parts of the UK. That was one of the messages from Gwyn Tudor, chief executive of the Cardiff-based MediWales forum, “the independent life sciences network for Wales”, as he opened the BioWales in London 2026 conference and exhibition. Interviewed by In Vivo for his take on the current commercial and innovation climate for healthtech companies considering operations in Wales, he said that adoption of new technologies by NHS Wales can be just as much of a challenge as in England. He added that NHS Wales is an accessible partner and there is “always a conversation to be had in Wales about new technology and innovation.” Companies can access potential partners, supply chains and peer support through MediWales and events like MediWales Connects. Tudor said: “Building relationships to reduce friction and move projects faster by helping people work together in a less transactional, more relationship-based approach is a clear characteristic of Wales.” Its life sciences ecosystem of 288 companies, 12,000 employees and annual sales output of £2.5bn sales value from medtech, diagnostics, wound healing, regenerative medicine and cell therapy is relatively small on an international scale. But it punches above its weight in medtech and diagnostics, Tudor told delegates at the bustling BioWales event, explaining in this In Vivo podcast his goal of “keeping all life sciences stakeholders in the room to come up with solutions.” That includes the healthcare provider, he said.

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Generics Bulletin Executive Editor Dave Wallace discuss US Food and Drug Administration Commissioner Martin Makary’s appointment of Katherine Szarama as acting Center for Biologics Evaluation and Research director and the updated timeline for find a permanent director (:33), as well as and Makary’s approach compared to the recent Center for Drug Evaluation and Research leadership change (4:39). They also consider the impact of the US Supreme Court’s review of the generic drug skinny label policy (10:54). #pharma #business More On These Topics From The Pink Sheet Alternate Leadership Strategy: Deputy Director Szarama Is Acting US FDA Biologics Center Chief: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/alternate-leadership-strategy-deputy-director-szarama-is-acting-us-fda-biologics-center-chief-P6ZJLJY7YBDUXCG6DMWNYNIHUI/ US FDA’s Makary Expects To Name Permanent CBER Director Within Weeks As Prasad Departs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fdas-makary-expects-to-name-permanent-cber-director-within-weeks-as-prasad-departs-37ZOLQT6FNDARGPMZOE2EI2DPE/ Skinny Label At SCOTUS: Could Generics Maintain Carve-Out Authority No Matter The Decision?: ⁠https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/skinny-label-at-scotus-could-generics-maintain-carve-out-authority-no-matter-the-decision-54CTMA7XSBGIFF7WOYPGA26PGM/

Salvatore Viscomi, CEO and co-founder of Carna Health, discussed the company's pivotal work to combat the global crisis of chronic kidney disease (CKD).

In this episode of the China biopharma English-language podcast, Xu Hu talks about the siRNA area, including possible industry and R&D environment changes for Chinese firms developing these therapies and trends in deals of China-originated siRNA assets this year. Story link: Chinese siRNA Contenders Set For Transitions, Deals In 2026

The Life Sciences Hub Wales supports on oncology and cardiovascular disease technologies which are ideally at TRL6. Improved health outcomes is among the aims  of the LSHW as it decides where to place its support. Chris Jones of LSHW explained the rationale to Medtech Insight at BioWales 2026.

In the latest episode of the Over The Counter podcast, HBW Insight speaks with Ellie Adams, founder and CEO of QIVA Global – a strategy and operating partner to international consumer healthcare brands entering the Chinese market. Adams, who has spent more than two decades working in China, offers a frank, insider perspective on what it really takes to succeed in the world's second-largest consumer healthcare market. From the rise of "punk health" among Chinese youth to the fragmented social commerce ecosystem that bears little resemblance to anything in Europe or the US, Adams unpacks why some of the industry's biggest names are thriving in China while others are stumbling. The answer, she suggests, almost always comes down to one thing: a playbook built from the inside out. Timestamps: 2:00 – Introductions 4:00 – What does China’s consumer health market look like? 8:00 – Why are some firms succeeding and others struggling? 12:00 – What kinds of products do well in China? 14:00 – How do you export into China? 22:00 – What is the “positive list”? 27:00 – Is there such a thing as Rx-to-OTC switch in China? 29:00 – What are the risks of exporting to China? 35:00 – What is the future growth potential of the Chinese OTC market?