Citeline Podcasts

Audio roundup of selected biopharma industry content from Scrip over the business week ended 15 November 2024. In this episode: muscling into the obesity market; AbbVie’s schizophrenia failure; Bayer will not take risky bets; generally strong Q2 for Japanese majors; and AstraZeneca juggles China and growth questions.

https://insights.citeline.com/scrip/podcasts/quick-listen-scrips-five-must-know-things-6XHHXGKMXRBV7MMKZE2NJRDG6A/

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

Pink Sheet reporter and editors, and guest Michael McCaughan of Prevision Policy, continue the discussion of Donald Trump’s potential impact on the FDA, including how Robert F. Kennedy Jr. could change the agency as head of HHS (:37), whether lasting changes are coming to the FDA (13:00), and Commissioner Robert Califf’s request that industry help preserve the agency status quo (18:18).

More On These Topics From The Pink Sheet

Speed Of Novel Approvals In Jeopardy As RFK Jr. Lands US HHS Secretary Nod: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/speed-of-novel-approvals-in-jeopardy-as-rfk-jr-lands-us-hhs-secretary-nod-PBKQI3K2XBHK5F53ZBHRD6VX2Q/

Three Ways Trump Could Disrupt The US FDA: https://insights.citeline.com/pink-sheet/legislation/elections/three-ways-trump-could-disrupt-the-us-fda-5KPABNKMKVBWNMFBQGU6H6ZWKU/

Industry Support Key To US FDA’s Prospects Under Trump, Califf Says: https://insights.citeline.com/pink-sheet/legislation/elections/industry-support-key-to-us-fdas-prospects-under-trump-califf-says-73IBZRFLQVEERACL64N74IK5GM/

Republican Sweep Creates Smoother Path For Biopharma Policy Priorities: https://insights.citeline.com/pink-sheet/legislation/elections/republican-sweep-creates-smoother-path-for-biopharma-policy-priorities-R2UH6ULEN5DKHOOV3KGYSMSETE/

Anticipation And Trepidation About Trump’s Election Rise: https://insights.citeline.com/pink-sheet/legislation/elections/anticipation-and-trepidation-about-trumps-election-rise-YTCHNKQW4VA3PPY3GBF3BQLAOQ/

Scrip senior writer Joseph Haas discusses recent merger-and-acquisition activity in the biopharma sector with Gerardo Ubaghs, CFO of Frontier Medicines, and Jason Silvers, CFO of Generate Biomedicines. The panel looks at why M&A activity metrics declined during both the second and third quarters despite a strong start to the year and apparent positive conditions for dealmaking, as well as what impact the US election results could have on M&A going forward.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 8 November 2024. In this episode: what Trump might mean for pharma; Novo’s semaglutide hits mark in NASH; AstraZeneca leads the way in clinical trials; Viking’s weight loss data excite; and how to speed up MLR reviews.

https://insights.citeline.com/scrip/quick-listen-scrips-five-must-know-things-D4FI3E5BCNF2HNIP6TPK5KQ2A4/

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

In the latest episode of the In Vivo podcast, Noam Solomon, co-founder and CEO of Israeli-American biotech Immunai explains how his company is mapping the immune system and using AI to predict individual immune responses to drugs. Noam also discusses the company's own acquisitions, partnerships, the differences between innovation and invention, artificial biomedical intelligence (ABI) and barriers to personalized medicine.

Contract development and manufacturing organizations (CDMOs) are reshaping pharmaceutical production, playing a pivotal role in supply chain stability and driving innovation.

In today’s fast-evolving environment, CDMOs help life sciences companies enhance speed, flexibility, and efficiency, which ultimately advances access to life-saving therapies. Norstella provides tailored insights, tools, and intelligence solutions to support this progress, empowering companies to make informed decisions and optimize their manufacturing partnerships.

This year at CPHI Milan, our team observed key industry trends, including innovations to strengthen supply chains and enhance sustainable practices. At Citeline’s (a Norstella company) 11th Annual Global Generics & Biosimilars Awards, we also celebrated excellence in the generics sector.

Following the conference, Andrea Charles, VP of custom content at Norstella, and Andrew Warmington, Citeline’s manufacturing editor, joined Izabela Chmielewska, managing editor of custom content, to discuss major takeaways – from the BIOSECURE Act’s influence on global operations to advancements in biomanufacturing. Together, they explored how Norstella and Citeline drive solutions to streamline the journey from pipeline to patient.

Pink Sheet reporter and editors discuss potential changes that the incoming Trump Administration could make on the FDA, as well as worries about political interference in decision-making, and policy and staffing changes.

More On These Topics From The Pink Sheet

US FDA’s Drug Approval Norms Could Be Upended In Second Trump Term: https://insights.citeline.com/pink-sheet/legislation/elections/us-fdas-drug-approval-norms-could-be-upended-in-second-trump-term-ICH6FUN4OBHRJPN4QFJ4OPLHNU/

Warp Speed For All And A Boost For Small Biotechs In Trump’s Second Term, Ex-Official Says: https://insights.citeline.com/pink-sheet/legislation/elections/warp-speed-for-all-and-a-boost-for-small-biotechs-in-trumps-second-term-ex-official-says-DA3BUPKEWVGVNDEPG6JMVLV7UI/

With Trump’s Return, Pharma Trades Disagreeable Knowns For Uncertainty: https://insights.citeline.com/pink-sheet/legislation/elections/with-trumps-return-pharma-trades-disagreeable-knowns-for-uncertainty-N7ZMT6QOEZEUDEXOROKXAZBP6E/

FTC Under Trump Likely to Maintain PBM Focus But M&A Oversight May Moderate: https://insights.citeline.com/pink-sheet/legislation/elections/ftc-under-trump-likely-to-maintain-pbm-focus-but-ma-oversight-may-moderate-H3XQ4S3YJBDSBK2NIDZFM4ZQ34/

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia at HTLH on his vision for AI in health care. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 1 November 2024. In this episode: Lilly plans DTC tirzepatide ads; Pfizer’s Bourla defends strategy; expert views from BioFuture; China retains attractions for some; and AbbVie’s Aliada acquisition.

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

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

「Déjà Vu In England: Lilly’s Alzheimer’s Drug Kisunla Gets MHRA Yes, But NICE Says No（邦訳：アルツハイマー治療薬ケサンラ承認で議論再び、薬価負担に悩む英国）」

URL:　 https://insights.citeline.com/pink-sheet/geography/europe/united-kingdom/deja-vu-in-england-lillys-alzheimers-drug-kisunla-gets-mhra-yes-but-nice-says-no-OX4YRPW4AFAYXAQVANZSSHURP4/

※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