Citeline Podcasts

Citeline의 최신 연구보고서에 따르면 미국시장에서 대형 일본제약사들의 항암제, CNS 치료제 허가가능성이 상대적으로 높은 것으로 나타났다. 어떤 요인이 작용했을까? (Scrip 기사를 요약한 내용입니다)

https://scrip.pharmaintelligence.informa.com/SC148677/Whats-Behind-Japan-Firms-Higher-Approval-Rates-In-Challenging-Oncology-CNS-Areas

In this episode of Medtech Connect, EU Senior Reporter Eliza Slawther and US Reporter Hannah Daniel explore the similarities and differences between EU and US regulations for digital health products in this mid-season recap episode. We talk about cybersecurity legislation, reimbursement of digital health products, and current AI regulations, so if you are looking for a bird’s eye view of regulations in these two places, this is the episode for you.

Audio roundup of selected biopharma industry content from Scrip over the past business week. Links to discussed stories at the link below:

https://scrip.pharmaintelligence.informa.com/SC148789/Quick-Listen-Scrips-Five-MustKnow-Things

Scrip’s Mumbai-based senior editor Vibha Ravi speaks with Dr B N Manohar, CEO of Indian cell and gene therapy firm Stempeutics Research. The company counts Cipla as an investor and has partnered with both Cipla and Alkem Labs for the marketing of cell therapy Stempeucel. This became the first patented cell therapy platform to be approved for commercial use in India, for knee osteoarthritis and critical limb ischemia. Manohar talks about these and other topics including plans and strategy.

Brian Yang, Dexter Yan and guest Jin Wang discuss trending biotech topics including recent antibody deals, China biotech innovation and underlying drivers as well as the outlook for the sector, in this Chinese-language podcast. Other topics include BioNTech’s recent China R&D collaborations and COVID-19 vaccine developments.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb looks back at ADA 2023 highlights and her interviews with diabetes company execs. Reed Miller discusses his Cardio Conversation with Volta Medical and Hannah Daniel discusses the FDA’s Clinical Decision Support Software final guidance.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

Diabetes, ADA 2023

Better Therapeutics Plans Diabetes PDT Launch Following FDA De Novo Authorization

Exec Chat: Tandem CEO Sheridan On Coming Mobi Pump, New Algorithms, And Taking Share From Medtronic

‘Closest To What The Pancreas Would Actually Do’: Medtronic Diabetes Execs On Marketing Plans for MiniMed 780G

Exec Chat: Dexcom’s CEO On Meeting New CGM Markets While Scoping Consumer Opportunities

AI, Regulatory Watch

Cardio Conversations: 'Trials, Trials, Trials!' Volta Has Big Ambitions For AI In EP

What Changes To The AI Act Would Benefit Medtech Most?

CDS Final Guidance Infringes On Free Speech, Professor Says

9xchange CEO Anat Naschitz and Benevolent AI's Matthew Fujisawa spoke with In Vivo about how they are trying to make selling and buying pharma assets more efficient through a digital marketplace and AI.

Digitalisation is a hot topic in consumer health, and “digital health” covers a broad spectrum of applications, from wellness apps to virtual reality therapeutics. In this episode, HBW Insight speaks to regulatory expert Jamie Hatzel to get some clarity on “software as a medical device” – a subset of medical device regulatory frameworks within which many digital health applications are classified. In the first part of a two-part podcast, Hatzel briefly outlines the UK and EU regulatory approaches to SaMDs, before we discuss specific examples such as symptom trackers, wellness apps and digital therapeutics. In the second part, we talk about artificial intelligence, how incoming AI regulations impact SaMDs and whether OTC firms should take the plunge into this highly regulated but nevertheless very exciting space.

Explore best practices for gathering, preparing, and managing data for clinical Phase I clinical trials from start to finish.

Learn about the cost- and time-saving benefits of basing early phase and first in human clinical trials in Canada.