Episodes
-
Guest speaker Guangzuo Luo, chief scientific officer of Bioncetech, joins China-based editors Brian Yang and Dexter Yan in this episode, which looks at Chinese biotechs going global, and the opportunities and challenges in the latest industry latest trends.
https://scrip.citeline.com/SC150370/China-Biotech-Podcast-Going-Global-Trends-Rare-Disease-Drug-Development
Playlist: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma?si=80b1209c44874afa9c44bf7d30538320&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharing -
In an interview with Scrip, JB CEO Nikhil Chopra addresses rumours of a sale of a stake in the Indian pharma/CDMO company by private equity fund KKR, recent acquisitions, including from Novartis, as well as JB's ambitions to ramp up the cardiology segment and its CDMO business, which already has major clients including J&J.
https://scrip.citeline.com/SC150350/Amid-Talk-Of-KKR-Stake-Sale-JB-CEO-Stresses-Business-As-Usual -
Episodes manquant?
-
Audio roundup of selected biopharma industry content from Scrip over the business week ended 31 May 2024. In this episode: ASCO preview; Asahi’s US acquisition; Novartis aims for renal disease dominance; paying for gene therapies; and US BIOSECURE Act diluted.
https://scrip.citeline.com/SC150361/Quick-Listen-Scrips-Five-MustKnow-Things
Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things -
In this episode we unpack the Corporate Sustainability Reporting Directive (CSRD) with the help of ESG expert Jasper Crone, drilling down into exactly what consumer healthcare companies need to know about this enormously complex and significant piece of EU legislation.
3:30 Introduction to the CSRD
7:45 What companies are affected by the CSRD
15:00 Specific implications for consumer health companies
21:00 Getting materiality right
25:00 CSRD to do list
32:00 Who’s afraid of targets?
37:00 Who’s responsible for CSRD in companies?
39:00 CSRD and the EU Green Deal
45:00 How will CSRD shape the way companies operate? -
Advancing Investigational New Drugs (INDs) can be a complex process, especially for smaller companies. Listen to your free podcast now as Marcus Delatte, PhD, Vice President at Allucent and Harshini Neelakantan, Executive Director at Ridgeline Therapeutics discuss best practices and considerations for leveraging your pre-IND meeting and submitting a successful IND application.
Listen now for insights into:
• Current trends and challenges related to IND submissions
• The purpose and benefits of pre-IND meetings with regulatory bodies
• Indicators that should prompt companies to request a pre-IND meeting
• The role of consultants in supporting sponsors in pre-IND meetings
• Getting the most from your pre-IND meeting and tips for IND application success
• How IND submissions will evolve in the future -
NeuShen CEO Joan Shen discusses with Brian Yang about developing CNS drugs in China, the venture's business rationale, challenges and fundraising. She also discusses two leading assets for schizophrenia and epilepsy in first-in-human studies, as well as a gene therapy collaboration for ALS with UMass's Gao Lab.
https://scrip.citeline.com/SC150328/China-Biotech-CEO-Interview-Starting-A-CNS-Venture-In-An-Economic-Downturn
Playlist: https://on.soundcloud.com/AaFyPUxfD2RiDEis5 -
As the 15 July entry deadline for the 3rd edition of the annual Citeline Japan Awards approaches, join us in this bilingual English/Japanese podcast to learn more about the categories and event itself. (Japanese starts at 2' 25".)
English event site: https://www.citeline.com/en/awards/citelinejapanawards
Japanese event site: https://www.citeline.com/ja-jp/awards/citelinejapanawards -
Audio roundup of selected biopharma industry content from Scrip over the business week ended 24 May 2024. In this episode: Biogen’s immunology acquisition; AstraZeneca looks to cement respiratory lead; why US FTC is tough on pharma; the US election’s impact on pharma; and how new AI tools are impacting medical affairs.
https://scrip.citeline.com/SC150324/Quick-Listen-Scrips-Five-MustKnow-Things
Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things -
Pink Sheet editors discuss the US FDA’s consideration of regulatory changes to promote innovative clinical trial designs (:32), an NIH proposal to require patent licensees create plans to ensure access to the commercialized product (7:29), and lawmakers longing for the days when Janet Woodcock ran the FDA’s Center for Drug Evaluation and Research (15:35).
More On These Topics From The Pink Sheet
‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches: https://pink.citeline.com/PS154730/Antiquated-Regulations-Slowing-Adoption-of-Innovative-Clinical-Trial-Approaches
US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution’ In Research: https://pink.citeline.com/PS154721/US-FDA-Looking-To-Modernize-Clinical-Trial-Regulations-To-Spur-Evolution-In-Research
NIH Drug Patent Licensees Would Develop ‘Access Plan’ Under Proposal; Pricing Commitments Optional: https://pink.citeline.com/PS154744/NIH-Drug-Patent-Licensees-Would-Develop-Access-Plan-Under-Proposal-Pricing-Commitments-Optional
Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach: https://pink.citeline.com/PS154745/Woodcock-Nostalgia-GOP-Rep-Bilirakis-Wants-CDER-To-Recapture-Her-Flexible-Approach -
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
「Hibernating Squirrels And Exercise In A Pill: The Next Wave of Cardiometabolic Therapies( 邦題意訳:GLP-1を超える心代謝系治療薬のヒントは、冬眠するリスか、地道な運動か)」
(日本語版)
https://www.citeline.com/ja-jp/resources/hibernating-squirrels-and-exercise-in-a-pill
※全文の閲覧には情報の登録(無料)が必要です。
(英語版)
https://scrip.citeline.com/SC150222/Hibernating-Squirrels-And-Exercise-In-A-Pill-The-Next-Wave-of-Cardiometabolic-Therapies
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 -
In this episode of the In Vivo podcast, Hakim Yadi, CEO and co-founder of UK techbio company Closed Loop Medicine, discusses how his company is pairing software and predictive analytics with medications old and new to tailor drug dosing to each patient.
-
In this episode, HBW chats with John Hite of the leading producer responsibility organization administering three Extended Producer Responsibility laws launching next year. With a 1 July deadline to register for his PRO, Circular Action Alliance, Hite discusses steps companies should take now, how his organization will assist producers and expectations on fee collection.
-
빅파마 기업들의 블록버스터 신약 확보 전략에 대한 Scrip 기사를 요약한 내용입니다.
https://scrip.citeline.com/SC150256/Development-Versus-Dealmaking-How-To-Obtain-A-Blockbuster
Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini -
In this episode, HBW Insight catches up with Albert Swane, founder and CEO of Dutch consumer healthcare firm, TheOTCLab, to talk about business strategy. Having grown the company with widely successful European OTC medical devices like Dr. Yglo, FungeX and Kidsner, Swane is perfectly placed to explain how to create and grow OTC brands. Swane also offers some sage advice on partnering, reflects on the fantastic opportunity of TheOTCLabs expanding into the US, and shares his experiences of using social media to raise the profile of the OTC industry.
-
Audio roundup of selected biopharma industry content from Scrip over the business week ended 17 May 2024. In this episode: the life of a blockbuster; blockbusters by indication; gene therapy struggles; sun shines on AstraZeneca and GSK; and Korean ventures look to Japan.
https://scrip.citeline.com/SC150281/Quick-Listen-Scrips-Five-MustKnow-Things
Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things -
Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee (:30), whether industry would improve clinical trial diversity with tougher enforcement of the regulation (22:26), as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program (33:07).
More On These Topics From The Pink Sheet
As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs: https://pink.citeline.com/PS154707/As-Biosecure-Bill-Mores-Forward-Clock-Ticking-For-Industry-To-Move-Away-From-Chinese-CDMOs
BIOSECURE Act Update Offers Biotech Companies Eight Years to Divest Contracts With Firms Of ‘Concern’: https://pink.citeline.com/PS154692/BIOSECURE-Act-Update-Offers-Biotech-Companies-Eight-Years-to-Divest-Contracts-With-Firms-Of-Concern
Senate Work On Biosecurity Issues Continues Even As House Is Current Focus Of Legislative Activity: https://pink.citeline.com/PS154688/Senate-Work-On-Biosecurity-Issues-Continues-Even-As-House-Is-Current-Focus-Of-Legislative-Activity
US FDA Asked To Tighten China Risk Control By Legislators As Markup Looms: https://pink.citeline.com/PS154675/US-FDA-Asked-To-Tighten-China-Risk-Control-By-Legislators-As-Markup-Looms
‘Do It Or We’re Not Going To Approve Your Drug:’ Industry Reps Ask FDA For Trial Diversity Sticks: https://pink.citeline.com/PS154696/Do-It-Or-Were-Not-Going-To-Approve-Your-Drug-Industry-Reps-Ask-FDA-For-Trial-Diversity-Sticks
US FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals: https://pink.citeline.com/PS154702/US-FDA-Using-Platform-Ideas-Outside-Of-Formal-Designations-To-Speed-Cell-and-Gene-Approvals -
Flora gives an overview of the budding landscape of neoadjuvant therapy in melanoma and provides insight on the nuances of this market.
Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836
Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz
TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/
Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67 -
In this bilingual Chinese- and English-language edition, China-based editors Brian Yang and Dexter Yan, along with guest speaker Derrick Gingery from the Pink Sheet in the US, discuss the planned US BIOSECURE Act and markup vote. Brian and Dexter also look at recent R&D updates from Chinese biopharma firms on their antibody-drug conjugate pipelines.
https://scrip.citeline.com/SC150255/China-Biotech-Podcast-BIOSECURE-Markup-Biotech-Pipeline-Updates
Other podcasts in the series: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma - Montre plus