Citeline Podcasts

Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren (:35), PBM executives again appearing unscathed after another Capitol Hill appearance (10:12), and the growing push to ensure the FDA’s rare pediatric disease priority review voucher program is renewed (20:41). More On These Topics From The Pink Sheet Shuren Steps Down As US FDA Device Center Director: https://pink.citeline.com/PS155031/Shuren-Steps-Down-As-US-FDA-Device-Center-Director PBM Execs Stay On Message Amid Growing US Congressional Frustration At Hearing: https://pink.citeline.com/PS155030/PBM-Execs-Stay-On-Message-Amid-Growing-US-Congressional-Frustration-At-Hearing FDA Leadership Changes Tune On Pediatric Priority Review Voucher Benefit: https://pink.citeline.com/PS155019/FDA-Leadership-Changes-Tune-On-Pediatric-Priority-Review-Voucher-Benefit

Join Victoria Bradley and Dr. Andrew Freeman as they discuss the latest advancements in heart failure treatment, from innovative therapies to the role of AI and personalized medicine. Discover how technology is revolutionizing patient care, ensuring patient safety, and improving outcomes.

This Q&A session emphasizes early diagnosis of COPD for better lung function preservation and disease control. It explores COPD symptoms, diagnosis tools, treatment options, and the importance of lifestyle changes, especially smoking cessation.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: Zeto Wins FDA Clearance For Novel Seizure Detection Device Outdated Technology Keeping Surgeons From Operating At Their Best: Medtronic Report :: Medtech Insight DeepWell DTx Brings Mental Health To Meta Store Healthtech Leaders Discuss Impact (And Risks) Of Generative AI And AI In Health Care Is This Doomsday Concern, Or Is It Reality? Verily CMO On AI’s Future, Lightpath Metabolic, More News We’re Watching: UK Plans Digital Health Guidance, FDA Warns Against Getinge/Marquet Cardiac Devices

Audio roundup of selected biopharma industry content from Scrip over the business week ended 19 July 2024. In this episode: J&J’s Spravato on track for blockbuster status; US uptake of Rezzdifra held up by payers; CNS drugs are surprisingly valuable; obesity rules large cap stocks; and Legend buyout rumors validate China biotech. https://scrip.citeline.com/SC150621/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.

Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments. More On This Topics From The Pink Sheet Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals: https://pink.citeline.com/PS154948/Pharma-Looks-To-America-First-US-FDA-Holds-Overwhelming-Lead-Over-EMA-In-Novel-Approvals Getting To Global Is A Hurdle For Cell And Gene Therapies: https://pink.citeline.com/PS154953/Getting-To-Global-Is-A-Hurdle-For-Cell-And-Gene-Therapies New Oncologics Overwhelmingly Approved In US Before EU: https://pink.citeline.com/PS154952/New-Oncologics-Overwhelmingly-Approved-In-US-Before-EU Approval Geography: Novel Agent Landscape Across US And EU: https://pink.citeline.com/PS154950/Approval-Geography-Novel-Agent-Landscape-Across-US-And-EU US FDA Offers Faster Route To Market Than EMA: Details On All 108 Approvals: https://pink.citeline.com/PS154951/US-FDA-Offers-Faster-Route-To-Market-Than-EMA-Details-On-All-108-Approvals

신테카바이오 조해경 사장은 Scrip과의 인터뷰에서 국내 AI 신약 개발 현황을 글로벌 흐름와 비교하고, 국내외 경쟁에서 살아남기 위해 국내업계가 해야 할 일에 대해 이야기했습니다. https://scrip.citeline.com/SC150336/Korea-Looks-To-Close-Gap-In-AI-Drug-Development-Capabilities

Discover the key considerations critical to the genetic analysis for advanced therapies, including qPCR and dPCR. Don’t miss expert insights from Chandler Walker, Product Manager of Digital PCR Instruments at Thermo Fisher Scientific and Janelle Hart, managing editor at Citeline.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 12 July 2024. In this episode: Q1’s top 10 drugs; Pfizer’s R&D leadership succession; Lilly bolsters IBD pipeline; first half deal volume up but value down; and EU firms’ China sentiment plummets. https://scrip.citeline.com/SC150587/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials.

Improving Communication: The Relationship Between Biotech And Biopharma by Citeline

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 今回取り上げた記事はこちら 「US FDA’s Cell-Gene Therapy Office Head Wants Sponsors To Seek Out Meetings（ 邦題意訳：米国FDAの細胞遺伝子治療室長「もっと面談を」企業に求める理由は）」 （英語版） https://pink.citeline.com/PS154749/US-FDAs-Cell-Gene-Therapy-Office-Head-Wants-Sponsors-To-Seek-Out-Meetings ※全文の閲覧には購読（有料）が必要です。 世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

Audio roundup of selected biopharma industry content from Scrip over the business week ended 5 July 2024. In this episode: US approval for Lilly’s Alzheimer's contender; the challenges and rewards of late-stage ADCs; Eisai regains control of ADC from BMS; RSV vaccine developers hit by declining expectations; and an interview with Amgen’s Ian Thompson. https://scrip.citeline.com/SC150550/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Joseph Haas, Mandy Jackson and Kevin Grogan discuss the biopharma dealmaking environment as we reach the midpoint of 2024. Haas reviews dealmaking data from the first six months of the year and discusses what experts expect in the months ahead. Jackson and Grogan talk about the industry mood coming out of the annual BIO conference in June and what they heard at the meeting.

In this episode of the In Vivo podcast, Billy Boyle, CEO of Owlstone Medical, discusses how his company is developing several breath biopsy products for use by clinicians, biopharma companies and researchers.

In Vivo Podcast Episode with Stefan Woxström by Citeline

Aspirin is celebrating its 125th anniversary this year. To find out what brand owner Bayer Consumer Health is doing to celebrate this occasion, and what it is doing to take the brand into the next 125 years, HBW Insight chats with the company’s senior vice president, Global Head Allergy, Cough/Cold, Pain and Heart Health, Reese Fitzpatrick, and head of R&D, North America and Therapeutics, Rachel Koontz. Already used for a variety conditions by consumers and patients across the world, the Aspirin brand has much more to offer, they argue, for example, in terms of digital self-care, with the firm working with British medtech firm Huma Therapeutics on a Heart Health Risk Assessment app that it currently markets in the US and Middle East. Aspirin also still has Rx-to-OTC switch potential, they reveal, for example in markets like Mexico where the brand is not already available without a prescription. And if that’s not enough, we also discuss Bayer’s extension of the Aspi brand into the naturals space, particularly in the cough and cold category in Europe. Timestamps 2:25 – Introductions 3:30 – Aspirin’s 125th anniversary 5:50 – Aspirin’s brand longevity 14:15 – Challenges of self-care 25:20 – Digital self-care and chronic conditions 27:50 – Aspirin’s Rx-to-OTC switch potential 33:30 – Science and self-care 39:90 – Natural alternatives 44:15 – What’s next for Aspirin?

Audio roundup of selected biopharma industry content from Scrip over the business week ended 28 June 2024. In this episode: global CEO remuneration; another late-stage loss for Merck KgaA; deals shift to smaller M&A, partnering; Bayer’s Parkinson’s bets bear fruit; and India looks to innovate CAR-T models. https://scrip.citeline.com/SC150517/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials.