Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.
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Digital Health Roundup: US FDA’s ‘Idea Lab’; Philips’ Roy Jakobs On AI Draft Framework; Apple Watch
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In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s draft framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for me…
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April Datamonitor Podcast 2024: AAN coverage
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Flora and Emma are joined by Datamonitor’s CNS analysts Summer, Joseph, and Wen-Yu to discuss coverage from AAN.Other platforms (in addition to SoundCloud):Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vy…
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Scrip's Five Must-Know Things - 30 April 2024
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 26 April 2024. In this episode: 2023’s top selling drugs and the COVID cliff; falling sales force Roche to reassess priorities; Phase III immunology win for Sanofi; BMS’s strong pipeline: and which companies could be acquired next.https://scrip.citeline.com…
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2024 Global Generics & Biosimilars Awards by CitelineBy Citeline
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Podcast: Facilitating Patient Monitoring in CAR-T Development
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Learn how molecular technology is enhancing patient safety for CAR-T clinical trials. US FDA recently initiated class safety labeling changes after evaluating the safety of CAR-T cancer treatment therapies. What does this mean for developers in the CAR-T landscape? Listen to your free podcast to find out.Listen in on the conversation as experts fro…
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Drug Fix: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics
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Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation (:34), upcoming guidance on accelerated approval for gene therapies (14:15), and partisan attacks on the agency from Capitol Hill (27:13).More On These Topics From The Pink SheetRx Advertising: Interchangeabili…
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Dr. Xue Discusses Treatment Guideline Updates for COPD in This Q&A Session
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Pulmonologist Bing Xue, MD, reviews the latest GOLD guidelines and discusses relevant topics regarding COPD treatment.By Citeline
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China Biotech Podcast - 26 April 2024 (Chinese and English Language)
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Join Scrip's China-based editors Brian Yang and Dexter Yan in this Chinese/English podcast as they look at data presented to AACR by Chinese pharma firms and recent acquisitions of China-based companies. UK-based writer Andrew McConaghie also joins to provide his perspectives, including on the proposed US BIOSECURE Act.https://scrip.citeline.com/SC…
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Future Governance & Oversight of the EU Medtech Regulatory System
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Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.By Citeline
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Citeline - Cerba Research Podcast V2 by CitelineBy Citeline
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Scrip M&A Podcast: Are Buyers Coming For Viking, Verona, Altimmune, Xenon And Crinetics
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Scrip's Joseph Haas, Kevin Grogan and Edwin Elmhirst talk about the biopharma M&A environment and which companies might look particularly appealing to potential acquirers.By Citeline
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Turning That Frown Upside Down: Treating Depression With Facial Botox Injections
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In this episode of the In Vivo podcast, Eric Finzi, CEO of Healis Therapeutics, discusses how his company is targeting major depression, post-traumatic stress disorder and other mental illnesses using facial botox injections.By Citeline
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Helping Consumers ‘Tune In’ To Reliable Health Information, With Kaizo’s Anita Nahal“Consumers are rewriting the rules when it comes to where they are going for information and the type of information they are looking for,” reports Kaizo’s Anita Nahal, speaking to HBW Insight’s Over the Counter podcast about the agency’s latest Communicating Health…
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Scrip's Five Must-Know Things - 22 April 2024
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 19 April 2024. In this episode: Teva’s immunology biosimilar launches; Intra-Cellular’s promising depression data; Phase III sleep apnea win for Lilly’s tirzepatide; an interview with Viking’s CEO; and China looks to define innovative drugs.https://scrip.ci…
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Drug Fix: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
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Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi (:28), Janet Woodcock’s new post-FDA role (12:28), and ongoing preparations for new pneumococcal vaccines that will reach the market soon (17:28).#business #pharmaMore On These Topics From The Pink SheetMedicare Spending Forecast For Leqembi Reflects CMS …
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Next-Generation Diagnostics: "Breathomics" From Imspex
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A new diagnostic technology to screen and triage individuals based on breath.By Citeline
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Ratio Therapeutics On BMS Buy-In, Radiopharma R&D Trends, AI And Assets
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Scrip’s senior editor Vibha Ravi speaks with Jack Hoppin, CEO and chairman, and John Babich, chief scientific officer, at Ratio Therapeutics, about the company’s radiopharmaceuticals pipeline, investment by BMS, use of AI, trends and developments in radiopharma research like combining ADCs or PARP inhibitors and more.https://scrip.citeline.com/SC15…
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China Biotech Podcast (Chinese- and English-language) - April 2024
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In this Chinese- and English-language episode, guest speaker Treehill Partners co-founder Ali Parshadezah joins Brian Yang and Dexter Yan to discuss updates on the proposed US BIOSECURE Act and US-China biotech movements, including recent M&A activity.https://scrip.citeline.com/SC150090/China-Biotech-Podcast-BIOSECURE-Updates-GenmabProfound-Deal…
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Scrip's Five Must-Know Things - 15 April 2024
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 12 April 2024. In this episode: the shifting sands of pharma R&D; big pharma oncology strategies; semaglutide’s promise in heart failure; AstraZeneca looks to multiple cancer modalities; and an interview with Astellas’s chief strategy officer.https://scrip.…
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Drug Fix: US FDA Adcomm Open Public Hearings, Clinical Trial Diversity Plans, Stealth’s Elamipretide
38:41
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Pink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings (:36), agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans (20:52), and Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide getti…
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In Conversation With 2024 In Vivo Rising Leader, Hanadie Yousef
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In this episode, In Vivo speaks to 2024 Rising Leader Hanadie Yousef, CEO of Juvena Therapeutics, about her journey, the secretome as a source of therapeutics, longevity medicine and alternatives to GLP-1 inhibitors for obesity.By Citeline
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Scrip's Five Must-Know Things - 8 April 2024
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Audio roundup of selected biopharma industry content from Scrip over the business week ended 5 April 2024. In this episode: Genmab buys into ADCs; Roivant set to take on AbbVie in uveitis; Ipsen signs firs ADC pact; South Korea looks to build biotech momentum; and the end of the road for Acorda.https://scrip.citeline.com/SC150062/Quick-Listen-Scrip…
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Drug Fix: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USA
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Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed (:32), an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees (9:08), and Japan’s PMDA opening an office in Washington D.C. (16:19).More On…
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Medtech Connect Episode 14: Live From HIMSS 2024
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In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.By Citeline
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피노바이오, 국내 ADC 생태계 발전에 기여할 것 (Korean-language podcast)
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기술 수요와 공급의 '불균형' 속에서 국내 ADC 업체들은 생태계를 발전시키려 노력하고 있습니다. Scrip의 정두영 피노바이오 대표 인터뷰기사를 요약한 내용입니다.https://scrip.citeline.com/SC149716/How-Pinotbio-Is-Helping-Build-Koreas-ADC-EcosystemBy Citeline
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Scrip's Five Must-Know Things - 1 April 2024
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Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Merck & Co progresses cardiovascular strategy; Novo purchase builds heart failure presence; CRL setbacks for Regeneron; ITF faces challenging Duchenne field; and AbbVie needs to freshen up.https://scrip.citeline.com/SC150030/Quick-Listen-Sc…
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Analysing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen
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In this episode, HBW Insight’s Europe and US editors Tom Gallen and Malcolm Spicer bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago, Kenvue, soon to celebrate its first anniversary as a new company; …
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March Datamonitor Podcast 2024: The US Inflation Reduction Act
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Flora and Ian are joined by Datamonitor’s financial analyst Abby, who discusses the Inflation Reduction Act and drug pricing trends in the US.Other platforms (in addition to SoundCloud):Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZW…
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Scrip's Five Must-Know Things - 26 March 2024
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Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: another big deal in radiopharmaceuticals; BioNTech’s ADC pipeline; China CDMOs embrace uncertain future; at look at the rivals in MASH; and industry views on how AI might be transformative.https://scrip.citeline.com/SC150008/Quick-Listen-Sc…
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Drug Fix: Mifepristone And Misinformation At SCOTUS, Understanding US FDA’s ODAC
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Pink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access (:34), the SCOTUS reaction to the fight against misinformation (18:28), and the FDA’s Oncologic Drugs Advisory Committee going against three negative product reviews (31:23).More On These Topics From The Pink SheetMifepristone Supporters Highlight…
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China Biotech Podcast (Chinese language) - March 2024
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Guest speaker Kevin Duan joins Brian Yang and Dexter Yan to discuss the proposed US BIOSECURE Act, the US FDA's approval of a China-origin anti-PD-1 drug and the latest developments in the antibody-drug conjugate area.By Citeline
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Digital Health Roundup: EU’s AI Act Impact; Verily's Andrew Trister’s Vision For Personal AI Agent
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Listen to the podcast via the player below:Medtech Insight articles addressing topics discussed in this episode:In Five Years, People Will Navigate Their Health Care With An AI-Advisor – Verily’s Andrew TristerVerily’s Andrew Trister On Uniting The Pieces To Create Personalized Health, EquityEuropean Parliament Adopts AI Act, But Success Hangs On T…
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Scrip's Five Must-Know Things - 18 March 2024
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Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Galderma prepares to take on Dupixent; Pfizer’s plans for Adcetris in DLBCL; Lilly’s donanemab approval delayed again; the psychedelic R&D pipeline; and an interview with BMS’s CDTO Greg Meyers.https://scrip.citeline.com/SC149962/Quick-List…
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Over The Counter 18 March 2024 1 by CitelineBy Citeline
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【3分で解説 世界のファーマ】第17回 LSDで不安症を治療 第III相開始へ (Japanese-language podcast)
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Summary: 今回取り上げた記事はこちら「MindMed Ready To Take LSD Therapy Into Phase III For Anxiety(MindMed、LSD療法を不安症治療の第III相治験へ)」https://www.citeline.com/ja-jp/resources/mindmed-ready-to-take-lsd-therapy-into-phase-iii-for-anxiety※全文の閲覧には情報の登録(無料)が必要です。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。(英語版)http…
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"Identifying The 80% Of Undiagnosed And Misdiagnosed Patients"
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Vibhor Gupta, director and founder of Pangaea Data, talks to In Vivo about the value of identifying the 80% of patients with undiagnosed or misdiagnosed conditions, and how his company is addressing this need.By Citeline
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Scrip's Five Must-Know Things - 11 March 2024
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Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Bayer won’t split, for now; Pfizer’s next-gen ADC pipeline; oncology dominates investment but other areas grow; goodbye NASH, hello MASH; and BMS’s CEO gives his views on India.Links to the stories discussed are here: https://scrip.citeline…
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Drug Fix: Vanda Appeals US FDA Jet Lag Denial In Court, Mark Cuban Battles PBMs, Austere FDA Budget
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Pink Sheet reporters and editor discuss Vanda’s decision to sue the FDA over the rejection of the Hetlioz jet lag indication (:30), Mark Cuban’s comments at a White House event that the federal government and others should stop doing business with the big three PBMs (11:50), and the cut in non-user fee dollars in the FY 2024 FDA appropriations bill…
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Scrip이 묻다: 2024년 제약바이오업계 전망은? 치료영역의 발전 (Korean-language podcast)
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2024년 글로벌 전문가들이 예측하는 치료영역의 발전은 무엇인 지에 대한 Scrip 기사를 요약한 내용입니다https://scrip.citeline.com/SC149780/Scrip-AsksWhat-Does-2024-Hold-For-Biopharma-Part-6-Therapeutic-Area-AdvancesBy Citeline
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Medtech Connect Episode 13: Augmented Reality In Surgery
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In this episode, US regulatory reporter Hannah Daniel speaks to Ocutrx CEO Michael Freeman about augmented reality in medical products and their not-so-unique regulatory requirements.By Citeline
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Scrip's Five Must-Know Things - 4 March 2024
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Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: optimistic outlook for biopharma IPOs; Boehringer’s promising MASH results; Viking emerges as obesity contender; Incyte looks to portfolio diversification; and a look at China’s HPV vaccine market.https://scrip.citeline.com/SC149879/Quick-L…
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Cardio Conversations: iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
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iRhythm CEO Quentin Blackford returns to Medtech Insight’s Cardio Conversations podcast to talk about the launch of the company’s new Monitor long-term cardiac monitoring patch, the company's plans for the MCT market, and a lot more.By Citeline
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The Emerging Benefits Of ‘Beauty-From-Within,’ Featuring Kenvue’s Paul LaTerra
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In this episode of Over the Counter, HBW Insight speaks to Paul LaTerra, Director, R&D, Global Hair and Scalp for Kenvue, a New Jersey-based consumer health company that markets skin care brands Neutrogena, Aveeno and Lubriderm. We discuss growth of the beauty-from-within supplements market, how the products complement topical skin care and hair fo…
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February Datamonitor Podcast: 2024 Clinical Outlook
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Emma and Flora outline expected trends and exciting upcoming events across therapy areas for 2024, straight from the subject matter experts at Datamonitor.Other platforms (in addition to SoundCloud):Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836Google Podcasts - https://podcasts.google.com/feed/a…
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NodThera On The Role Of The Brain In Driving Chronic Disease
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Alan Watt, CEO of NodThera, a clinical-stage biotech developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases, talks to In Vivo about the company’s pipeline and recent data publication in the field of obesity. The company is focused on developing drugs that inhibit the NLRP3 inflammasome, a validated drug targ…
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Scrip's Five Must-Know Things - 26 February 2024
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Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Bayer takes strategic steps to cut debt; AbbVie confirms internal appointment as CEO; another RIPK1 setback for Denali/Sanofi; new biotech reality in China; and ex-Daiichi Sankyo CEO shares insights into tough decisions.https://scrip.citeli…
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Drug Fix: US FDA And Psychedelic Drugs, Aduhelm Clinical Trial Data, Adcomm Candidates
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Pink Sheet reporters and editors discuss the FDA’s approach to psychedelic drugs (:25), whether postmarket clinical trial data from the Alzheimer’s drug Aduhelm will be published (16:32), and the FDA offering more time to find candidates for its new Genetic Metabolic Diseases Advisory Committee (27:19).More On These Topics From The Pink SheetLykos’…
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AESGP’s 60th Birthday Celebrations In 2024 Including Annual Meeting, With Jurate Švarcaite
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The Association of the European Self-Care Industry celebrates its 60th birthday this year. In this episode, we catch up with AESGP director general, Jurate Švarcaite, to find out how the association will mark the occasion, including at this year’s Annual Meeting in Brussels in June. AESGP Annual Meetings are an excellent way to find out what the ke…
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Drug Fix: Price Negotiation Suit Tossed, Drug Shortage Probe, FDA-Approved Marijuana
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Pink Sheet reporters and editors discuss the dismissal of PhRMA’s suit challenging the Medicare price negotiation provisions (:30), the US FTC and HHS investigation of drug shortages (12:01), and the potential for FDA-approved marijuana products (23:47).More On These Topics From The Pink SheetPhRMA’s Lawsuit Against Medicare Trips Over ‘Administrat…
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Drug Fix: State Of The Generic Industry, US FDA Under Second Trump Term, Inspections And Shortages
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Pink Sheet reporter and editors discuss the issues and concerns raised during a major generic industry conference (:42), former FDA Commissioner Scott Gottlieb’s views on what a second Trump term as president would mean for the agency (13:54), and congressional hearings on FDA foreign manufacturing facility inspections and drug shortages (23:51).Mo…
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