Citeline Podcasts

By NorstellaBusiness

Citeline Podcasts episodes

September 01 Making The Case For Switch, With AESGP’s Christelle Anquez-Traxler
Products like ibuprofen and loratadine are now grabbed off a pharmacy shelf without a second thought, but both started out as prescription-only medicines.
The process that moves a drug from one to the other, known as Rx-to-OTC switch, is one of the most reliable forms of innovation in self-care, and yet it happens less often than the industry would like.
In this episode of Over the Counter, now also in video, HBW Insight talks to Christelle Anquez-Traxler, senior regulatory science and strategy lead at the Association of the European Self-Care Industry, AESGP, ahead of the association’s first switch conference, taking place in Brussels on 7 October.
Anquez-Traxler argues that switch is still undervalued by regulators who tend to focus on the risks of reclassifying a medicine rather than the benefits, and that just one year of data protection in the EU, against three in the US and Japan, leaves companies with little reward for doing the work.
We talk about what makes some switches harder than others, how approaches to evidence such as the BRASS model can help close the gap, and why recent national initiatives in France, Greece and Germany might point the way forward for the rest of Europe.
29 min
August 31 ZS On How AI is Reshaping The Patient's Approach to Care Delivery - a View From the US, China and Germany
A landmark three-country survey by the ZS consulting and technology firm , which shows the rapid trend towards patients' uptake of AI tools that empower them on their healthcare journeys. ZS’ Jon Roffman and Bhargav Mantha set the scene.
36 min
August 28 Drug Fix: MFN Finds Mid-Size Companies And More Vaccine Policy Moves
Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential differences between Most Favored Nation drug pricing agreements for small and mid-size companies and the largest pharmas (1:03), as well as the impact of potential vaccine policy changes on the US public health apparatus (15:10).
More On These Topics From The Pink Sheet
MFN Deal Impact Unclear As White House Ready To Announce Agreements With Mid-Size Pharmas: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/mfn-deal-impact-unclear-as-white-house-ready-to-announce-agreements-with-mid-size-pharmas-ECRFYU4TOVBSPG63U26CWI5FIM/
HHS Builds A Legal Firewall Around Its Next Vaccine Moves With RFI On Federal Categories: https://insights.citeline.com/pink-sheet/vaccines/hhs-builds-a-legal-firewall-around-its-next-vaccine-moves-with-rfi-on-federal-categories-5HILL2G52BE3PI5BJTJ4UZ76RI/
30 min
August 28 【3分で解説 #世界のファーマ】第30回　米国、ジェネリック関税に国内外から懸念／BMSとAZ合併の噂 (Japanese-language podcast) Aug. 28, 2026
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.
As US Threatens A Tariff Bomb On Generic Drugs, Will Exemptions Be Negotiated? https://insights.citeline.com/pink-sheet/policy-regulation/as-us-threatens-a-tariff-bomb-on-generic-drugs-will-exemptions-be-negotiated-6NUJIGIPNFCT5HRSSIEIXJSJZY/
Trump Tariff Action On Generics Highlights Temporary Nature Of Exemptions https://insights.citeline.com/scrip/business/strategy/trump-tariff-action-on-generics-highlights-temporary-nature-of-exemptions-GJOW5MWMOJBKLEWSDMM222DTYI/
Trump’s Generic Tariff Clock Demands Compression Of US FDA Review Timelines https://insights.citeline.com/pink-sheet/biosimilars-and-generics/trumps-generic-tariff-clock-demands-compression-of-us-fda-review-timelines-5C4DXMVVCRGRRGXG2QRUH62GTQ/
BMS Likely Main APAC Beneficiary Of Any AstraZeneca Mergerhttps://insights.citeline.com/scrip/business/deals/bms-likely-main-apac-beneficiary-of-any-astrazeneca-merger-NVNVSZTPHFBAXHZR6H6IPI35JU/
※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
4 min
August 25 Videocast: Goodwin’s Sophie McGrath – A Legal View Of Healthtech And Biopharma Trends
A videocast for the In Vivo podcast section, with Goodwin's Sophie McGrath - talking about healthtech and pharma trends.
Innovation, investment, legal, Goodwin, Sophie McGrath, EU, Europe
41 min
August 22 Drug Fix: What FDA Commissioner Nominee Heidi Overton Will Mean For The Agency
Pink Sheet Editor-in-Chief Nielsen Hobbs, executive editor Derrick Gingery, and senior reporter Maaisha Osman discuss new FDA commissioner nominee Heidi Overton, her prospects for confirmation, and what her pick means for the agency.
More On The Topic From The Pink Sheet
FDA Commissioner Nominee Has The White House’s Trust. Winning Over Career Staff Is Another Matter: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-commissioner-nominee-has-the-white-houses-trust-winning-over-career-staff-is-another-matter-IIZWK46CFVHMBIZF5XM7L4PQ6U/
Trump To Nominate White House Advisor Overton As FDA Commissioner: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/outgoing-georgia-congressman-buddy-carter-eyed-for-fda-commissioner-RHIYQUYTIVGRTFEXYCHCWPG54Y/
31 min
August 21 Bonus Episode: Inside Endocyclic’s Precision Peptide Strategy For Endometriosis Diagnosis And Treatment
One in ten women has endometriosis, yet treatment options remain largely unchanged for decades. Tanya Petrossian, CEO of EndoCyclic Therapeutics, explains how her company's non-hormonal peptide platform - now FDA-cleared for human trials - could finally change that.
33 min
August 17 Strategic Intent: The Rise Of Mid-Cap Dealmakers
Biopharma’s small-to-mid-cap players are stepping up as serious acquirers. David Wild and Scrip’s Jessica Merrill unpack how companies like argenx, Insmed, Jazz, Genmab, UCB, and BioMarin are using M&A to extend growth beyond their first commercial successes and what that shift means for investors, dealmaking, and the next generation of big biotechs.
17 min
August 17 Building The GLP-1 Companion Category, With Beverley Law And Martina Gripp
Everyone in consumer health is talking about GLP-1s. While this new generation of weight loss drugs is firmly on the prescription-only side, industry is now thinking about how it can meet users’ needs for products that address side effects and the nutritional gaps that come with rapid weight loss. In this episode of HBW Insight’s Over the Counter, ALL Creative founder Beverley Law and consultant Martina Gripp – who has 25 years’ experience in industry including at Boehringer Ingelheim and Perrigo – unpick what a companion products category actually requires. We talk claims and the grey area around referencing a prescription brand, the difference between a product marketed for GLP-1 users and one that ends up being used by them, what a real evidence investment looks like from bibliographic data through to a clinical trial, and what OTC companies should be doing right now.
A quick update for our listeners: HBW Insight now has its own dedicated podcast channel. To stay up to date on the latest, follow HBW Insight’s Over The Counter podcast on Spotify and Apple Podcast. You'll find the link in this episode's description.
For any podcast feedback or queries, you can now reach us at [email protected]
48 min
August 14 Drug Fix: Understanding The PDUFA VIII Revenue Cut And GDUFA IV Name Change
Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the important provisions of the new prescription drug and generic drug user fee commitment letters (:53), including the revenue cut coming in PDUFA VIII (7:16), as well as the new formal meeting names (13:53) and “America First” incentives (23:47) in GDUFA IV.
More On These Topics From The Pink Sheet
US FDA Will Start PDUFA VIII Collecting Less Revenue, But Will Fees Drop?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-will-start-pdufa-viii-collecting-less-revenue-but-will-fees-drop-3VJC34BDRZFHHMY5N5YIODQRZ4/
Generic Drug User Fee Deal Creates Domestic-Focused Incentives, Could Lower Application Fees: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-user-fee-deals-creates-domestic-focused-incentives-could-lower-application-fees-UOG7BGF2YNA3NMWHLFMM2C2BFU/
Generic Drug User Fee Agreement Streamlines Meetings, Creates ‘Complex Issue’ Goal Extension: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-drug-user-fee-agreement-streamlines-meetings-creates-complex-issue-goal-extension-TZFGYWV2VNCF3M7GJWPOJZ66SI/
29 min

About Citeline Podcasts

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Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and…