Citeline Podcasts

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