MHRA’s Rob Reid updates on timings for CE marking, pre-market SI and possible EU MDR outcomes

Audio roundup of selected biopharma industry content from Scrip over the business week ended May 22, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – industry grapples with MFN fallout; rapid early trials fuel China deals; AbbVie looks to grow in neuroscience; is circular DNA the next big thing?; and a flunk for Regeneron’s fianlimab. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-I3FWWY2VRBAJND24H372L2CGIY/

"Biotechs are running increasingly complex clinical trials with lean teams, tight budgets, and growing pressure to deliver faster results. In this episode, Claire Riches, VP, Clinical Solutions, Citeline is joined by Carrie Melvin, Head of Clinical Operations and Data Management, Lantheus to explore how smarter outsourcing, stronger CRO partnerships, and patient‑focused trial design can improve execution, control costs, and reduce operational risk, while avoiding unnecessary burden on sites and participants. View the video series and find out more information here: https://www.citeline.com/biotech"

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年5月22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: 行业正努力应对最惠国待遇政策带来的影响；早期临床试验进展迅速推动中国市场合作；艾伯维（AbbVie）寻求在神经科学领域扩张；环状DNA会是下一个重大突破吗？；以及Regeneron公司的fianlimab遭遇挫折。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-I3FWWY2VRBAJND24H372L2CGIY/

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the impact of the US Food and Drug Administration’s purge of multiple center directors and other senior executives in the wake of Commissioner Martin Makary’s resignation (:34). They also discuss the agency’s potential new direction and the initial comments of some of its new leaders (15:12). More On These Topics From The Pink Sheet US FDA’s Real-Time Clinical Trial Pilot Seeks Expansion As Chief Architect Departs: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/us-fdas-real-time-clinical-trial-pilot-seeks-expansion-as-chief-architect-departs-VOTFGD45X5DZXGCAMNJU2AKN6M/ Acting CDER Director Warns AI Over-Reliance Will Trigger GMP Violations: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/acting-cder-director-warns-ai-over-reliance-will-trigger-gmp-violations-7UO5KN7SJJBBLPQT7SLT3SWCJI/ US FDA Chief AI Officer Departs, But Ousted Chief Of Staff, Acting CBER Director Staying: https://insights.citeline.com/pink-sheet/geography/north-america/united-states/ousted-us-fda-chief-of-staff-acting-cber-director-will-stay-after-leadership-shake-up-HXJONIRQ5VAVVNWDKHK7Z2BA2E/ 13 Center Directors Across CDER, CBER In 17 Months … And Counting: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/13-center-directors-across-cder-cber-in-17-months-and-counting-WFYVLZPFOBEN3IICCDM5LSKWZU/ Diamantas Extends Olive Branch To US FDA Staff Amid Senior Leader Shake-Up: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-tracy-beth-hoeg-expected-to-depart-cder-CUQUEBUE3BHZ3G52UW4I7SM6BE/

MHRA’s Rob Reid spoke to Ashley Yeo at MTF 2026 on issues affecting UK and Great Britain medtech regulation

As biotech models evolve, boards, clinical leaders, and investors are being forced to rethink how value is created. In this episode, Claire Riches, VP, Clinical Solutions, Citeline is joined by Ross Pettit, Chief Development Officer, Kestrel Therapeutics, to explore how leaner operating models, sharper board governance, ROI‑driven clinical decisions, and the rapid rise of China’s biotech ecosystem are redefining what “modern biotech” looks like today. #biotech #drugdevelopment #clinicaltrials #clinicaldevelopment #biotechstrategy #biotechleadership #clinicaloperations #ROI #ChinaBiotech  View the video series and find out more information here: https://www.citeline.com/biotech

As global clinical development strategies evolve, Europe is emerging as a critical hub for scientific innovation, operational agility, and patient recruitment — reshaping its role in the future of clinical trials. In this episode, Scott Davis, Vice President of Clinical Services at Novotech, joins Andrew Warmington from Citeline to explore how sponsors are rethinking Europe’s place in global development programs amid shifting geopolitical, regulatory, and operational dynamics. They discuss: ·       Why Europe continues to lead through scientific expertise and clinical innovation ·       How sponsors are optimizing trial design, startup, and recruitment strategies across the region ·       The growing importance of flexible CRO–sponsor partnerships in global development ·       How Europe complements the US and APAC in modern clinical trial strategies ·       What regulatory evolution and operational change could mean for Europe’s future competitiveness Tune in to hear how Europe is adapting to a rapidly changing clinical landscape and why the region is poised to play an even greater role in the future of global clinical trials.

Ovid Therapeutics Chairman Jeremy Levin talks with Scrip about how the US should view its biotech sector as a strategic national asset and urges the venture capital sector to place more emphasis on supporting early and innovative science.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年5月15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: 葛兰素史克（GSK）强化下游肥胖症战略；诺和诺德（Novo）在早期肥胖症口服药市场占据优势； 罗氏对瑞士的支持面临压力；恒瑞与百时美施贵宝达成重大研发联盟；PCSK9药物Lerochol在美国以更低的直接成本上市。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HHL7OZN4TBH43HXIIRB2G7BYUI/

Audio roundup of selected biopharma industry content from Scrip over the business week ended May 15, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – GSK bolsters downstream obesity strategy; Novo winning early obesity pill market; Roche’s support for Switzerland under strain; Hengrui and BMS strike huge R&D alliance; PCSK9 drug Lerochol launched in US at lower direct cost. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HHL7OZN4TBH43HXIIRB2G7BYUI/