Citeline Podcasts

In Vivo speaks with Ashley Zender, CEO of Fauna Bio, a company using AI to identify drug targets based on natural disease resistance in animals. The company's $494m partnership with Eli Lilly is a testament to the value of their approach.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 17 January 2025. In this episode: a look at JPM; J&J’s Intra-Cellular buy; how JPM Day 1 deals fit into BD strategy; Scrip asks about the global state of biopharma; and what will fuel M&A activity in India this year.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JVFXFPYT4VFX5GEKYAVA55FOMU/

Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Juho Jalkanen, CEO of Faron Pharma, discusses the importance of addressing unmet medical needs in cancer through breaking treatment resistance and developing long-term solutions. In Vivo questions the current progress of their lead asset BEXMAB and its potential moving forward.

Pink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms (:24), comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters (12:35), and diverging trends between CDER and CBER novel application approvals (21:53).

More On These Topics From The Pink Sheet

Trump’s US FDA Reforms Need Center Director, Staff Support To Succeed, Former Leaders Say: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/trumps-us-fda-reforms-need-center-director-staff-support-to-succeed-former-leaders-say-VCCGXSBJGZGXPHEYJFAHIHEI7A/

Exit Interview: US FDA’s Patrizia Cavazzoni Says CDER Staff In ‘Best Place Possible’: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/exit-interview-us-fdas-patrizia-cavazzoni-says-cder-staff-in-best-place-possible-IN6GTBFEJZDSNOI4T23CRYK7OY/

Innovation Drives Divergence: US FDA Drugs and Biologics Centers Follow Own Trajectories: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/innovation-drives-divergence-us-fda-drugs-and-biologics-centers-follow-own-trajectories-MDZ5DSCKKNEYPF6PVTXAMFHGF4/

US FDA’s Median Review Time Remains Less Than One Year Despite Swell Of Missed Goal Dates: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/us-fdas-median-review-time-remains-less-than-one-year-despite-swell-of-missed-goal-dates-VIEE6AVOQRGMZNKB53B52GPQG4/

Clocking The Speed Of US FDA 2024 Novel Approvals: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/clocking-the-speed-of-us-fda-2024-novel-approvals-3HT7CAIO4VBJDIJZVGBHLAUCSY/

Audio roundup of selected biopharma industry content from Scrip over the business week ended 10 January 2025. In this episode: key themes for JPM; 2024 launches a breakout for liver disease; obesity drug readouts this year; IgA nephropathy snapshot; and only half of 2024 launches were from big pharma.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-SV3WFD7NQJEW3FDTUDZICD2IKE/

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet editors discuss Center for Drug Evaluation and Research Director Patrizia Cavazzoni’s surprising retirement announcement (:32), the importance of the large bolus of guidance documents that the FDA released 6 January (12:42), and the FDA’s decision to continue reviewing and granting rare pediatric disease designations even though the program lapsed (18:48).

More On These Topics From The Pink Sheet

Digging Through The US FDA Guidance Blizzard: https://insights.citeline.com/pink-sheet/legislation/elections/digging-through-the-us-fda-guidance-blizzard-TR6LKKXLZ5C5ZG5HUYDJ6XJO3M/

Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/artificial-intelligence-us-fda-outlines-7-steps-to-establishing-model-credibility-ZZTAXYUP3BDKPKLF6CVECQYO7M/

Accelerated Approval: US FDA Explains When A Confirmatory Trial Is ‘Underway’: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/accelerated-approval-us-fda-explains-when-a-confirmatory-trial-is-underway-YP2DRCCKFBHJHOJ7K7LKH2AX4U/

Off-Label Communications: US FDA Clarifies Safe Harbor For Firm-Generated Presentations: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/off-label-communications-us-fda-clarifies-safe-harbor-for-firm-generated-presentations-DEDRJWWNWBAUJPTEVI2GLHGI4M/

US FDA Still Reviewing Rare Pediatric Disease Designation Requests Despite Program Lapse: https://insights.citeline.com/pink-sheet/rare-diseases/us-fda-still-reviewing-rare-pediatric-disease-designation-requests-despite-program-lapse-EJSANI3SL5GATG66ZMVYVCME4E/

트럼프 대통령의 취임 직전 열리는 2025년 JP모건 헬스케어 컨퍼런스에서 라이센스딜 및 M&A 뿐 아니라 미국 정치와 정책도 주목 받을 것이라는 Scrip 기사의 요약입니다.

https://insights.citeline.com/scrip/conferences/jp-morgan/jpm-2025-deals-politics-and-parties-to-welcome-a-new-year-for-pharma-5XBXOFPQMNB3ZBWVSWIIY5Y7IM/

Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

As we enter 2025, In Vivo convened a group of biotech executives for a wide-ranging conversation about dealmaking this year and the challenges and opportunities for companies in the cardiometabolic, longevity, radiopharmaceuticals and cancer spaces. Essential listening before JPM.

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

Related Links:

https://insights.citeline.com/medtech-insight/pickleball-smart-homes-brain-games-caregiving-agetech-take-centerstage-at-aarps-ces-2025-presence-CIGK5RS7EVG2XH3XBQSUYDQXI4/

In this episode of the In Vivo podcast, Harvard immunologist and co-founder of early-stage biotech Corner Therapeutics, Jonathan Kagan, talks about harnessing the power of the innate immune system by weaponizing dendritic cells and creating immunotherapies that are safer and more durable.