Citeline Podcasts

In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?

In this episode, HBW Insight chats with Austen El-Osta, Director of the Imperial Self-Care Academic Research Unit (SCARU) at Imperial College London, about the emerging "self-driven healthcare" concept, or SDH for short. Coined by research funding agency, Innovate UK, El-Osta hopes the self-driven healthcare concept will provide a new focus for the booming self-care industry, while also placing the UK at the centre of innovation. We discuss what makes self-driven healthcare different from “self-care,” as well as the opportunity for consumer healthcare companies.

바이오텍 가치하락, 바이오신약의 특허 만료 등 시장상황의 변화로 글로벌 제약바이오 업계가 새로운 인수합병 파도에 휩쓸릴 수 있다는 Scrip Intelligence 기사를 요약한 내용입니다.

https://scrip.pharmaintelligence.informa.com/SC146589/Are-Market-Conditions-Setting-Up-A-Biopharma-MA-Wave

Scrip’s Five Must-Know Things – 18 July 2022 by Citeline

Articles mentioned in this podcast:

US FDA Has 10 Months To Provide Answer On Perrigo/HRA OTC Oral Contraceptive Application

Allowing States To Ban Abortion Services Increases Calls For Making Birth Control Available OTC

OTC Switch For Daily Oral Contraceptive Brandished In Senate Health Care Policy Duel

Barriers To US OTC Emergency Contraceptive Sales Remain Despite Court Rebuke Of Restrictions

Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process And For Consumers

Dual Rx/OTC Status In US ‘Additional Condition’ Switch Proposal: Necessary Or Questionable?

US FDA May Play Central Role In Assuring Access To Mifepristone Post Roe v. Wade

Mifepristone Access Imperiled By Supreme Court’s Draft Decision Overturning Abortion Rights

With Roe v. Wade In Rearview, What’s Next For Women’s Health

Telemedicine Among Sticky Wickets As Uncertainty Abounds Post-Roe v. Wade

Period-Tracking Apps Should Safeguard Data, Reassure Customers In Post-Roe Era

Pink Sheet reporters and editors discuss the FDA’s latest COVID-19 vaccine emergency use authorization, activities during the FDA commissioner’s remaining time in office, and patients requesting a gene therapy risk management plan.

In this month’s Digital Health roundup, Medtech Insight’s Barnaby Pickering discusses DeHealth, which developed a platform built on cryptocurrency, and executive interviews with Glooko and Omada Health about their diabetes platforms. Marion Webb will highlight a conversation with Nixon Gwilt Law attorney Bethany Corbin about key steps developers of period-tracking apps can take to ensure that sensitive health data remains safe and private. Reed Miller discusses Braidio’s health information platform and Pyx Health’s hybrid solution for loneliness.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

Period-Tracking Apps Should Safeguard Data, Reassurance Customers In Post-Roe Era

Building Digital Platforms To Bridge Diabetes Care Gaps

DeHealth Applies Blockchain To Medical Data Transactions In Bid For Transparency

Pyx Health Is Addressing The Loneliness Crisis With Digital/Human Combination

Minute Insight: Braidio’s My Health Concierge Service Incorporates BlueSemi’s Eyva Health Tracker ‘Gadget’

Pink Sheet reporters and editors discuss new changes to the Senate drug pricing bill, the FDA’s decision to call a second advisory committee meeting for Amylyx’s ALS drug, and Covis’ request to skip a vote during the hearing on Makena’s withdrawal.

欢迎来Citeline中国生物制药热点博客做客！

分析热点，政策解读和行业热门追踪是我们的宗旨。

在首期的节目中，中国主编杨宏新Brian和资深记者严洁Dexter首先讨论了康方生物最新获得药监局批准，世界首个双特异抗体卡度尼丁单抗Cadonilimab，治疗宫颈癌（https://scrip.pharmaintelligence.informa.com/SC146649/China-Approves-Worlds-First-Bispecific-IO-Drug-Amid-PD-1L1-Glut）。

这个获批也是中国第一个批准治疗宫颈癌的肿瘤免疫治疗。默克的K药比较，这个获批有什么意义？对于其他在研的双特异抗体PD-1来说有什么影响？

接下来的话题是最近国家药监局公布《关于进一步加强外资企业服务工作的通知》，其中特别提出要加快临床急需境外新药，罕见病，儿童用药和重大传染病新药的审评审批 （https://pink.pharmaintelligence.informa.com/PS146428/Invitation-Extended-New-Chinese-Policies-Aim-To-Lure-Foreign-Pharma-Firms）

。此外，亮点还包括：专栏链接制度，畅通企业诉求沟通渠道，作为“稳外资稳外贸”的一环，这些新政策将带来新药获批的加速和监管交流沟通的进一步加强。

Citeline的中国团队还讨论了抗体药物偶连体ADC的竞争格局，以及中国生物Sino Biopharma制药通过旗下InvoX对于纳斯达克上市的英国抗体药企F-Star的1.61亿美元的收购 （https://scrip.pharmaintelligence.informa.com/SC146597/Asia-Deal-Watch-invoX-Builds-Novel-Pipeline-Through-$161m-F-star-Acquisition）。这个收购也是2022年中国生物药企的首个亿元级别的大手笔收购。此次收购对于ADC关注的中国药企来说，无疑是一剂强心剂。

如果你有任何建议，意见和希望听到我们讨论的话题，欢迎留言！我们还将不定期邀请特邀嘉宾一起来到博客间，和CIteline中国团队一起深度潜水，聊聊影响深远的生物制药领域的热点和政策话题。

感谢收听，让我们下一期节目见！

Podcast: BD’s Polen Pursues ‘True North’ Path To High-Value Growth by Citeline