Pharma Intelligence Podcasts

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs and special guest Dave Wallace, executive editor of Generics Bulletin, discuss the generic industry's future direction and priorities (:27) and the impact of recent policy moves on the biosimilar industry (12:28) following their trade association's annual meeting, as well as US Food and Drug Administration Commissioner Martin Makary's comment on compassionate use and the concern it may have caused industry (20:23). More On These Topics From The Pink Sheet The State Of The Off-Patent Union: AAM's Murphy Sets Out US Achievements And Obstacles: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/the-state-of-the-off-patent-union-aams-murphy-sets-out-achievements-and-obstacles-in-us-IHJH2CZBX5GGTI6UJQVE2WO2G4/ ‘Biology Is Dirty': HHS's Principal Deputy Counsel On How Biosimilar Firms Can Help US FDA: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biology-is-dirty-hhss-principal-deputy-counsel-on-how-biosimilar-firms-can-help-us-fda-2GEAUSXNMRCYNIXPS7P6IAYESE/ Makary's Compassionate Use Comments, Later Clarified, Still May Startle Industry: https://insights.citeline.com/pink-sheet/rare-diseases/makarys-compassionate-use-comments-later-clarified-still-may-startle-industry-XPBVZ6MH7FC7JKP2XEL4ZESWSE/

Swedish biotech Affibody has spent over two decades engineering proteins 1/20th the size of a conventional monoclonal antibody — and CEO David Bejker believes they're perfectly suited to solve one of radioligand therapy's biggest problems: a dangerously narrow target space. Bejker discusses how Affibody's platform combines the selectivity of antibodies with the biodistribution flexibility of small molecules, the science behind its Albumod technology, and how its HER2 imaging and therapeutic programs are translating from animals to humans. He also digs into partnerships with AstraZeneca's respiratory unit and complement-focused Rally Bio, manufacturing advantages of E. coli-based production, and Affibody's long-term ambitions as a commercial-stage company.

특허 만료와 미국 내 약가 압박은 대형 글로벌 제약사들이 극복해야 할 과제이며, 다수 제약사가 올해 소폭의 실적 상승을 전망하고 있다는 Scrip 기사를 요약한 내용입니다. https://insights.citeline.com/scrip/drug-pricing/drug-makers-confront-headwinds-in-2026-but-mfn-doesnt-seem-like-a-big-one-YYQBO72NSNCHBE6EBPKF2GSDB4/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年2月20日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻: 哈德森在赛诺菲的遗产；特朗普推动美国制药投资背后的现实；拜耳的精准医疗战略与增长；今年值得关注的临床试验；以及Scrip关于人工智能与运营卓越的专题访谈。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-GO7ZGTBFEJDA5OUKAXHCTBVBDU/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 20, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Hudson's legacy at Sanofi; the realities behind Trump's US pharma investment push; Bayer's precision medicine approach and growth; clinical trials to look out for this year; and Scrip Asks on AI and operational excellence. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-GO7ZGTBFEJDA5OUKAXHCTBVBDU/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss a series of US Food and Drug Administration proposals for user fee program changes that would advance President Trump's priorities and the concerns they raise (:31). They also consider the impact of the agency's decision to review Moderna's mRNA flu vaccine application shortly after refusing to file it and using accelerated approval for one of the proposed indications (8:37), as well as ideas for sponsors wondering if their development advice is still good (25:24). More On These Topics From The Pink Sheet US FDA Proposing White House-Aligned Policies For User Fee Agreements: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-proposing-white-house-aligned-policies-for-user-fee-agreements-D5JWRDGLCFBT7CYT3FGK3JAZNI/ After Moderna Flu Vaccine, Is US FDA's Accelerated Approval A Pathway Or A Pressure Valve?: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/after-moderna-flu-vaccine-is-us-fdas-accelerated-approval-a-pathway-or-a-pressure-valve-EWMFKFWO3BB3JA6CQHC4E3JWPA/ Moderna Flu Vaccine Debate Could Resolve With Postmarket Study, FDA's Makary Suggests: https://insights.citeline.com/pink-sheet/vaccines/moderna-flu-vaccine-debate-could-resolve-with-postmarket-study-makary-suggests-Y3R657N2JZABRGFOSKADM33YA4/ Horse Trading? Oz, Bourla Exchange MFN Codification, Vaccine Collaboration Requests: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/horse-trading-oz-bourla-exchange-mfn-codification-vaccine-collaboration-requests-X6UDDVOSMRBSTO5WC224IN6PTE/

Renée Aguiar-Lucander, CEO of Hansa Biopharma, discussed the company's leading asset, its journey toward US FDA approval and the trials and tribulations of completing a Phase III program.

In Part 2 of HBW Insight's conversation with sustainability leader Steve Ramus, we dig into the practical realities shaping the future of sustainability in consumer health, from what consumers are actually willing to pay for, to why packaging, supply chains and long‑term planning remain some of the industry's toughest challenges. Drawing on two decades of sustainability and ESG experience, Ramus explains how consumer price sensitivity varies across markets, why sustainability can ultimately make companies more efficient, and how inflation complicates the conversation. We also explore the complex world of pharmaceutical packaging — where safety, stability and regulation often collide with expectations around plastics, recyclability and waste — and why progress, though slow, cannot stall. Timestamps: 2:00 – Will consumers pay more for sustainable OTCs? 7:00 – You don't want to be unsustainable 9:00 – ESG is good for business 10:00 – Retailer expectations 15:00 – The state of play in OTC packaging 20:00 – The challenge of replacing plastic 23:00 – The challenge of recycling 27:00 – Sustainability priorities right now 31:00 – Supply chain 32:00 – The life of a sustainability professional Guest Bio: Steve Ramus is a global sustainability and ESG executive with 20 years of experience aligning strategy with business growth, risk mitigation, and value creation. As former Vice President of Sustainability & ESG at Perrigo, he led: ESG reporting, climate strategy, responsible sourcing, human rights due diligence, packaging circularity, community engagement and other initiatives that improved ESG ratings, delivered cost savings, and generated millions in incremental revenue. Steve advanced his career within the business having led teams in both HR and Sales, prior to his roles in sustainability.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年2月13日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻: Scrip问答—研发创新专题；拜耳“颠覆性”中风研究成果；阿斯利康精准肿瘤学战略；吉利德首席医学官谈研发管线；印度制药领袖论创新驱动。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EP6IJB43CRG7XBFEWVVN7V3FXE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 13, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Scrip Asks on R&D Innovation; Bayer's “paradigm-changing” stroke results; AstraZeneca's precision oncology approach; Gilead's CMO reflects on pipeline; and India's pharma chiefs on driving innovation. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EP6IJB43CRG7XBFEWVVN7V3FXE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration's controversial decision to refuse to file Moderna's mRNA-1010 seasonal influenza vaccine candidate, including the unusual public airing of grievances (2:10), the changing issues sparking RTF actions (5:51), the uncertainty created by the decision and how vaccine sponsors should react going forward (16:54). More On These Topics From The Pink Sheet Moderna Cites Changing Advice As US FDA Refuses To File Flu Vaccine BLA: https://insights.citeline.com/pink-sheet/vaccines/moderna-cites-changing-advice-as-us-fda-refuses-to-file-flu-vaccine-bla-SRLIEHHMOFEWFPTLYJCXFIF5FM/ HHS Defends US FDA Refusal To File Moderna's Flu Vaccine: https://insights.citeline.com/pink-sheet/vaccines/hhs-defends-us-fda-refusal-to-file-modernas-flu-vaccine-NULTQ6P6R5C6DDXZFMZROE3HRU/

Bronchopulmonary dysplasia affects up to 90% of extremely preterm infants, yet no approved therapies exist. In this episode of the In Vivo podcast, Airway Therapeutics CEO Marc Salzberg discusses how their Phase Ib study of zelpultide alfa, a recombinant surfactant protein D, showed substantial reductions in BPD incidence and mechanical ventilation time. Salzberg explains the unique challenges of running neonatal trials, navigating regulatory pathways for vulnerable populations, and why preventing BPD could unlock broader respiratory applications. From ethics and enrollment to EMA approval and global expansion, this episode explores what it takes to develop breakthrough medicines for the smallest, most fragile patients.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年2月6日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻—默克寻求填补Keytruda空缺；诺华力争突破最长专利到期期； 诺和诺德预警销售额大幅下滑；辉瑞看好肥胖症治疗前景；礼来期待奥福格利普隆取得成功。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JES32O67YRBSLC6UV2JFY5KPBQ/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 60, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Merck looks to fill Keytruda's shoes; Novartis aims to push through largest expiry period; Novo warns of steep sales decline; Pfizer bullish on obesity; and Lilly expects orforglipron success. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JES32O67YRBSLC6UV2JFY5KPBQ/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of new data showing US Food and Drug Administration hiring increasing, but net employee losses continuing (1:13), including how the issue could be reflected in the user fee program going forward (7:40) and where the strains will emerge as the agency continues to navigate its workload (11:43). More On These Topics From The Pink Sheet US FDA's Drugs, Biologics Centers See Increased Hiring, But Not Enough To Overcome Departures: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-drugs-biologics-centers-see-increased-hiring-but-not-enough-to-overcome-departures-XGMD6U2QHFGULBLCBTRCBWATNQ/ PDUFA VIII: Industry Proposes Funding Changes To Reflect ‘Realistic Ability To Hire Staff': https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/pdufa-viii-industry-proposes-funding-changes-to-reflect-realistic-ability-to-hire-staff-AALJBBI5BJEKLEBGIRFL6ZKDQA/ US FDA's Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-failure-to-implement-key-workforce-reforms-puts-oversight-at-risk-gao-says-B64V7RAIQNBNBI57ID5ZU3DYAE/ A Strong Year For US FDA Approvals, But Warning Lights Flashing: https://insights.citeline.com/pink-sheet/product-reviews/approvals/a-strong-year-for-us-fda-approvals-but-warning-lights-flashing-OEYQQ4RRDVHEVPAFYXPQ4LRHOA/

With the European Union rolling back parts of its Green Deal — including scaling back major legislation such as the Corporate Sustainability Reporting Directive and the Corporate Sustainability Due Diligence Directive — and the US splintering into state‑by‑state sustainability mandates, global OTC companies are facing a fresh wave of uncertainty around their sustainability strategies. It's no surprise, then, that many are acting and investing more cautiously. But for sustainability expert Steve Ramus, formerly VP for Sustainability & ESG at Perrigo, now is precisely when leadership matters most. Sustainability teams, he argues, should be helping their executives and boards see that doing the “right” thing is also the competitive thing. Companies that keep moving through the uncertainty, he says, will be faster, leaner and far better prepared than those waiting on the sidelines. Timestamps: 3:00 – Introductions 4:50 – The state of sustainability in consumer health 9:00 – The business case for sustainability 14:30 – Where are we heading? 17:20 – Making the case for sustainability within companies 20:30 – The chilling effect of uncertainty

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月30日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻—阿斯利康宣布重大中国投资计划；诺华高管警示早期临床试验竞争压力；中国生物科技企业借IPO筹资海外试验；默克公司谈成功交易；深度解析印欧自由贸易协定。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T7BHL2UUN5DY3ENU5ZRTCY7YIE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 30, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – AstraZeneca's big China investment pledge; Novartis exec's warning on early trial competitiveness; Chinese biotechs tap IPOs to fund foreign trials; Merck & Co on winning deals; and breaking down the India-EU free trade agreement. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T7BHL2UUN5DY3ENU5ZRTCY7YIE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss details recently unearthed about the role center directors play in the Commissioner's National Priority Voucher review process and the influence they could have over the review division (:32). They also discuss the CNPV Review Council's membership (16:58) and the program's resource needs (27:28). More On These Topics From The Pink Sheet US FDA CNPV Reviews Clarified: Center Director Approval Recommendations Not Binding, HHS Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fda-cnpv-reviews-clarified-center-director-approval-recommendations-not-binding-hhs-says-GRCFLKAPVZCWPGPT3I36B2WXI4/ FDA Voucher Program Approvals Will Come From Product Centers, But Ambiguity Lingers: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/fda-voucher-program-approvals-will-come-from-product-centers-but-ambiguity-lingers-KBX2KFYONBEEVF4AJN3PV2AH4A/ US FDA Adds Facility Data To Commissioner's Priority Voucher Pre-Submission Requirements: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fda-adds-facility-data-to-commissioners-priority-voucher-pre-submission-requirements-2XYJICOLOFBUNJVOTSXFNXSBSE/

Tim Lu, CEO of Senti Bio, joins In Vivo to discuss how programmable cell therapies are solving oncology's targeting problem. Lu explains the logic-gated approach behind SENTI-202, an allogeneic CAR-NK therapy for relapsed/refractory AML that achieved 50% response rates in Phase 1 while avoiding the dose-limiting toxicities that have plagued other AML cell therapies. We cover the Phase 1 ASH 2025 data showing 39% complete remission rates (all MRD-negative) with 7.6-month median duration, the rationale for using NK cells over T cells, and why synthetic biology's three-target logic gates can distinguish cancer from healthy bone marrow cells. Lu also discusses plans for pivotal trials following RMAT designation, expansion into solid tumors, and where biotech innovation is accelerating versus where clinical translation bottlenecks remain. For biopharma professionals tracking cell therapy innovation, synthetic biology applications, and AML treatment advances.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月23日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻—强生肿瘤业务前景；葛兰素史克收购Rapt交易；2026年最受期待的新药上市；摩根大通乐观的财务展望；以及Scrip对竞争格局的深度解析。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RQH7ZGCHCBHZXOVSG7V53XIV54/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 23, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – J&J's oncology prospects; GSK's Rapt deal; 2026's biggest expected launches; optimistic financial outlook at JPM; and Scrip Asks about the competitive dynamics landscape. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RQH7ZGCHCBHZXOVSG7V53XIV54/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip senior editor Jessica Merrill, Scrip US managing editor Mandy Jackson and In Vivo senior reporter David Wild discuss trends and topics from interviews and presentations at the J.P. Morgan Healthcare Conference and Biotech Showcase.

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs consider the US Food and Drug Administration's average speed of a novel drug application review in 2025 (:34), including the loss of so-called “fast approvals” (5:33) and how reviewers managed to ignore the distractions caused by the changes (7:35). They also consider whether the layoffs and other departures will impact the review system in 2026 (11:16). More On These Topics From The Pink Sheet Average Metrics In A Turbulent Year: US FDA's 2025 Median Review Times Match PDUFA Goals: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/average-metrics-in-a-turbulent-year-us-fdas-2025-median-review-times-match-pdufa-goals-FOEPKT27UFAHPDS36HKJFOHOQE/ It's About Time: US FDA's Review Speed For Novel Approvals In 2025: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/its-about-time-us-fdas-review-speed-for-novel-approvals-in-2025-6LMDCANRRZGWTIDSRKFVXCJRPY/ US FDA's 2025 Staffing Turmoil Will Create 2026 Application Review Challenges: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-2025-staffing-turmoil-will-create-2026-application-review-challenges-AJIE7WRQ2ZFS7IOR5PA3OWFE2M/

Antti Vuolanto, CEO of Herantis Pharma, discusses the significant unmet need in Parkinson's disease and outlines Phase II plans for the company's lead asset HER-096.

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 「Novartis Sounds Alarm Bell On Global Trade Policy（邦訳：ノバルティスが警鐘を鳴らす　自国第一主義の貿易政策めぐり）」 Article link: https://insights.citeline.com/scrip/drug-pricing/novartis-sounds-alarm-bell-on-global-trade-policy-GRXGDPFNE5E2VNHXZMK67CYEFI/ 公開書簡のURLはこちら Open Letter: https://www.novartis.com/sites/novartis_com/files/letter-to-global-governments.pdf?utm_campaign=pharmalittle&utm_medium=email&_hsenc=p2ANqtz--ND6BAwNYOXJlpATFKTFHmMTF6pv7a_72Ft7BD6JemCR-91pUUsDLTiRGjuqtDcyqTBbMVLBh_0RmYh8063YZw3HoWfPAwsgK6z1yCvjYrBnwAY4g&_hsmi=398727134&utm_content=398727134&utm_source=hs_email ※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

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月16日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻—摩根大通弥漫乐观情绪；Scrip探析2026年资本配置与并购趋势；安永指出中国并购增长值得关注；礼来收购Ventyx引发对NLRP3抑制剂的热议；诺和诺德基金会助力欧洲初创企业。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XE634WMH7FHA3AHR4MPJ65VOQM/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 16, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – optimism reigns at J.P. Morgan; Scrip Asks what 2026 holds for capital allocation and dealmaking; EY says keep eye on China as deals grow; Lilly's Ventyx buyout raises NLRP3 inhibitor interest; and Novo Nordisk Foundation backs Europe startups. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XE634WMH7FHA3AHR4MPJ65VOQM/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs consider the many concerns Richard Pazdur and others raised about the US Food and Drug Administration's Commissioner's National Priority Voucher Program (CNPV) (:37), including potential legal issues (10:35), as well as the possibility of releasing the full action package for an unapproved application, given the resources that likely would be required (18:16). More On These Topics From The Pink Sheet Commissioner's National Priority Voucher Program Reflects US FDA Review Politicization, Pazdur Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/commissioners-national-priority-voucher-program-reflects-us-fda-review-politicization-pazdur-says-A43CKFRDVBHTLESE6IQE6JXLGM/ US FDA Gauging Impact, Resource Use In Commissioner's Voucher Pilot As Concerns Grow: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-gauging-impact-resource-use-in-commissioners-voucher-pilot-as-concerns-grow-7WQB3TOQERGXJPAIV5465GOBLM/ With Unapproved Drug Complete Response Letters Now Public, Are Action Packages Next?: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/with-unapproved-drug-complete-response-letters-now-public-are-action-packages-next-S4Y5ANUYE5DOTC7YVTALA3GPIE/

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月9日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻—口服版Wegovy在美国上市； 2025年中盘股最大催化剂；去年小盘股转型与僵尸股清算；去年上市新药面临的商业逆风；以及中国企业全球三期临床动态。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZV4GVVROYBEN7I6DQBOMQ3A3XE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip의 2026년 글로벌 제약바이오 산업 전망 (1부: 자본배분과 딜메이킹)을 요약한내용입니다. https://insights.citeline.com/scrip/scrip-asks/scrip-asks-what-does-2026-hold-for-biopharma-part-1-capital-allocation-and-dealmaking-U3B4EUN3GZGNXM6QI3ZGXVMNZY/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 9, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – oral Wegovy launches in the US; the biggest mid-cap catalysts in 2025; small cap pivots and zombie killers last year; commercial headwinds for last year's launches; and a look at Chinese firms' global Phase III activity. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZV4GVVROYBEN7I6DQBOMQ3A3XE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

PreVision Policy Founding Member Michael McCaughan joins Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs to discuss the career and legacy of Richard Pazdur, the long-time head of the US Food and Drug Administration's oncology drug review division and Oncology Center of Excellence. They consider his brief stint as Center for Drug Evaluation and Research director and decision to retire (:55), his impact on oncology (4:36), as well as reflect on his famous “Pazdur Moments” (18:41), the future of legacy programs like Project Orbis (28:52), and whether the FDA can find another leader like him (33:54). More On These Topics From The Pink Sheet US FDA's Richard Pazdur: Appreciating An Extraordinary Career: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-richard-pazdur-appreciating-an-extraordinary-career-YD2GBQ7WOZHM5BNAKWJF4OQVFM/ Modernizing Accelerated Approval: One Of Pazdur's Biggest Legacies: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/modernizing-accelerated-approval-one-of-pazdurs-biggest-legacies-4QPXDRZ7SNBE7EUOG5VWWILGDY/

Intranasal vaccines are back in the spotlight as highly pathogenic avian influenza spreads among birds and spills over into mammals, including recent cases in dairy and poultry workers. In this episode of In Vivo, senior pharma and biotech reporter David Wild talks with Chad Costley, CEO of BlueWillow Biologics and Meagan Deming, an infectious disease researcher at the University of Maryland School of Medicine about a novel intranasal recombinant H5 flu vaccine that aims to stop infection at the gate by building mucosal immunity in the nose. They discuss recent Phase I data, pandemic‑flu preparedness, BARDA/NIH funding realities, and how BlueWillow's NanoVax platform could extend to other major respiratory threats, including TB.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年12月19日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻——再生元夹在成功与专利到期之间；第三季度十大畅销药物；礼来Retatrutide重塑减重标准；辉瑞坚守疫苗投资；赛诺菲在托布替尼困境中仍保持乐观。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XA4W4OYCVRCSNHW5ZL7TUFJF2U/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended December 19, 2025. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Regeneron caught between success and expiry; Q3's top 10 drugs; Lilly's Retatrutide Raises Weight-Loss Bar; Pfizer stands by vaccines investment; and Sanofi Upbeat Despite Tolebrutinib Tribulations. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XA4W4OYCVRCSNHW5ZL7TUFJF2U/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Matthew Wood, director and chief scientific officer at Oxford-Harrington Rare Disease Center, discusses the state of rare disease R&D, the evolving landscape of genomics and genetic therapies, and the challenges around the biopharma industry's narrow focus on only 5-10% of rare diseases.

This podcast brings you highlights from Scrip Awards 2025, including wins for AstraZeneca, Syndax, Akeso and Summit Therapeutics and the Lifetime Achievement Award for Flagship Pioneering's Noubar Afeyan.

Emma Wille and Summer Colling speak with ophthalmology expert, Joseph Jacob, to discuss the latest developments in dry age-related macular degeneration (dry AMD), including current treatments, emerging therapies, regulatory challenges, and the unmet needs shaping the future of patient care.

Scrip senior writer Joseph Haas and PwC analyst Roel Van den Akker look back on biopharma sector dealmaking in 2025, why deal values rose from 2024's lows, and look ahead to what the trends mean heading into 2026 in this latest edition of the Scrip M&A Podcast.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年12月12日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期聚焦美国血液学会（ASH）会议五大关键成果：Jaypirca有望成为一线疗法；Kite公司Anito-cel在多发性骨髓瘤领域的进展；新一代CAR-T疗法；Kelownia公司CAR-T疗法的早期体内数据；以及诺华公司ianalumab在ITP治疗中的潜力。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RFOOY2665REEZEN5SMJ2GW27EY/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended December 12, 2025. This week, a focus on five key results from the American Society of Hematology (ASH) meeting – Jaypirca headed for the front line; Kite's Anito-cel in multiple myeloma; next-generation CAR-T approaches; Kelownia's early in vivo CAR-T data; and Novartis's ianalumab's potential in ITP. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RFOOY2665REEZEN5SMJ2GW27EY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年12月5日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本次要闻: 特朗普在英国药品定价谈判中获胜；诺和诺德阐释司美格鲁肽治疗阿尔茨海默病的依据；强生与诺华达成年度最大并购交易；CAR-T疗法成效参差分析；阿克索制药的伊沃尼西马布后续目标。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-UZSVLBBSQRAKNJC7GDZWILMAT4/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended December 5, 2025. In this episode: Trump's UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year's biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso's goals beyond ivonescimab. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-UZSVLBBSQRAKNJC7GDZWILMAT4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug resistance derails even the most advanced cancer treatments, but what if we could restore sensitivity to existing therapies instead of starting over? Neil Bhowmick, chief scientific officer at Kairos Pharma, joins In Vivo to discuss how his company is tackling resistance in oncology. We explore the company's lead asset, ENV-105, which is showing over 13 months of progression-free survival in Phase II prostate cancer trials by resensitizing tumors to hormone therapy, with significantly lower toxicity than standard alternatives like chemotherapy or radiopharmaceuticals. Bhowmick explains the complex biology behind different resistance mechanisms, shares early data on GITR-modulating therapies designed to expand T cell populations for immunotherapy, and discusses their approach to developing companion biomarkers for patient selection. We also dive into the clinical and commercial rationale for combination approaches and what milestones to watch in the coming year.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs break down the pending retirement of Center for Drug Evaluation and Research Director Richard Pazdur and appointment of Tracy Beth Høeg as the interim replacement (4:51), including the potential impact on sponsors (15:46). They also discuss whether Høeg will take time to learn CDER operations before making changes (19:38), as well as the possibility of yet another CDER director being hired in the coming weeks or months (23:18). More On These Topics From The Pink Sheet US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Retires: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-us-fda-cder-director-richard-pazdur-retiring-SUPZZ4JEQ5GVHEEH4RPDLCNIBY/ Tracy Beth Høeg Named New Acting US FDA CDER Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tracy-beth-hoeg-named-new-acting-us-fda-cder-director-3AYJZJAMBVG6HNPX3FJ7IBCDHQ/ US FDA Sending Pazdur Back To Oncology Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-sending-pazdur-back-to-oncology-office-KVBDIDT2RVF4JAZ7FCZHN46XXU/

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 「The Rise of China Biopharma – Five Themes In 2025（邦訳：中国バイオファーマの勃興　2025年注目のテーマ5つとは）」 URL: https://insights.citeline.com/scrip/r-and-d/clinical-trials/the-rise-of-china-biopharma-five-themes-in-2025-GEB2XLG3CNDONIO5HE4S2FZOVI/ ※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

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年11月28日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本次要闻: 2027年医保降价幅度或低于CMS预期；赛尔安泰在DLL3肺癌ADC竞赛中领先；强生抗tau阿尔茨海默病药物posdinemab二期试验失败；拜耳阿苏德克赛安三期中风试验意外获胜；辉瑞/安斯泰来Padcev膀胱癌研究首获重大突破。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-R4RCDF2RXVGVHPEX2WQ7A3JVKU/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended November 28, 2025. In this episode: 2027 Medicare price cuts likely not as large as CMS estimates; Zai Lab leads DLL3 lung cancer ADC race; Phase II failure for J&J's Alzheimer's asset posdinemab; Bayer's positive Phase III data for asundexian in stroke; and Pfizer/Astellas's Padcev's first big win in bladder cancer study. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-R4RCDF2RXVGVHPEX2WQ7A3JVKU/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

최근 런던에서 열린 Jefferies 글로벌 헬스케어 컨퍼런스를 취재한 Scrip기사를 요약한 내용입니다 https://insights.citeline.com/scrip/business/start-ups-and-smes/jefferies-25-biotech-leaders-bullish-as-ma-heats-up-EAHTR2MNHJE65E74WLIMBXXK5I/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年11月21日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本次要闻: GLP-1药物之外的肥胖治疗新局；并购热潮中生物科技巨头的乐观预期；百时美施贵宝Milvexian遭遇挫折；临床专家解读MASH疗法演进；日本企业上半年业绩喜忧参半。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MXUR6OEDNNAEPPTTZ4YZKH55SU/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX