Citeline Podcasts

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: a look at global executive compensation; Pfizer’s new myeloma approval; Merck and Sichuan trump ADC breast cancer success; combo Alzheimer’s therapies in Eisai’s pipeline; and an overview of the state of gene therapy.

https://scrip.pharmaintelligence.informa.com/SC148914/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporters and editor discuss a projected list of drugs that could be eligible for the first round of Medicare price negotiations (:40), the future of mifepristone access after the latest court decision (9:24), and AstraZeneca receiving the first US FDA drug promotion warning letter in more than a year (21:55).

More On These Topics From The Pink Sheet

Medicare Price Negotiation List Remains A Puzzle, Even For Those That Are (Probably) On It: https://pink.pharmaintelligence.informa.com/PS148718/Medicare-Price-Negotiation-List-Remains-A-Puzzle-Even-For-Those-That-Are-Probably-On-It

Mifepristone REMS Modifications Likely Violated Administrative Procedure Act, Appeals Court Says: https://pink.pharmaintelligence.informa.com/PS148721/Mifepristone-REMS-Modifications-Likely-Violated-Administrative-Procedure-Act-Appeals-Court-Says

Breaking Down The Arguments In The Mifepristone Case: https://pink.pharmaintelligence.informa.com/PS148678/Breaking-Down-The-Arguments-In-The-Mifepristone-Case

The Mifepristone Story So Far: Tracing The Origins Of The Legal Fight Over The Abortion Pill: https://pink.pharmaintelligence.informa.com/PS148679/The-Mifepristone-Story-So-Far-Tracing-The-Origins-Of-The-Legal-Fight-Over-The-Abortion-Pill

AstraZeneca Gets Rare Warning Letter Over Breztri Sales Aid; Footnotes Don’t Balance Graphics: https://pink.pharmaintelligence.informa.com/PS148710/AstraZeneca-Gets-Rare-Warning-Letter-Over-Breztri-Sales-Aid-Footnotes-Dont-Balance-Graphics

In this special episode, we speak to PAGB CEO Michelle Riddalls about being a UK OTC Marketing Awards judge and what makes a good entry in her extensive experience. Having spent two decades working in some of the largest OTC companies in the world, and now heading up the UK’s OTC industry association that literally checks marketing campaigns before they go out, Riddalls is well placed to be able to give advice to companies working on their entries right now. Making entries UK-specific, data-driven but also inclusive of all the creativity that teams bring to a launch or campaign are some of the pointers Riddalls shares with us. Friday 1 September is the entry deadline for the 2023 Awards, which takes place at the Royal Lancaster Hotel in London on Thursday 23 November. If you are interested in entering, head over to Citeline’s 2023 UK OTC Marketing Awards (https://protect-us.mimecast.com/s/VmBtCOYEZru5kNmkATEGZ82?domain=citeline.com) home page.

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Wegovy’s solid new trial results; Lilly’s sales swing back; nothing off the table for new Bayer boss; new compliance crackdown in China; and McKinsey on AI.

https://scrip.pharmaintelligence.informa.com/SC148876/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporters and editors discuss the impact of a study showing cardiovascular benefits for the weight loss drug Wegovy (:45), another attempt to restrict mifepristone access (16:15), and a new threat to the US FDA’s hybrid work policy (26:35).

More On These Topics From The Pink Sheet

Wegovy’s Cardiovascular Benefits May Improve, But Not Transform, Insurance Coverage In Obesity:

https://pink.pharmaintelligence.informa.com/PS148672/Wegovys-Cardiovascular-Benefits-May-Improve-But-Not-Transform-Insurance-Coverage-In-Obesity

Obesity Advocates Meet With FDA Commissioner, Push On Difference vs. Short-Term Weight-Loss:

https://pink.pharmaintelligence.informa.com/PS148673/Obesity-Advocates-Meet-With-FDA-Commissioner-Push-On-Difference-vs-ShortTerm-WeightLoss

New Attack Against FDA’s Mifepristone Approval Targets Potential Water Contamination:

https://pink.pharmaintelligence.informa.com/PS148671/New-Attack-Against-FDAs-Mifepristone-Approval-Targets-Potential-Water-Contamination

Peter Marks’ Fears May Come True: White House Wants More In-Person Work:

https://pink.pharmaintelligence.informa.com/PS148674/Peter-Marks-Fears-May-Come-True-White-House-Wants-More-In-Person-Work

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

「 Tracking Industry’s Lawsuits Against IRA’s Medicare Price Negotiations（邦題意訳：アメリカ反インフレ法　薬価をめぐる法廷闘争の現在地）」

https://scrip.pharmaintelligence.informa.com/SC148794/Tracking-Industrys-Lawsuits-Against-IRAs-Medicare-Price-Negotiations

世界の薬事規制ニュースPink Sheet（ピンクシート）とは？

https://www.citeline.com/ja-jp/products-services/regulatory-and-compliance/pink-sheet

In the second part of HBW Insight’s chat with Bristows digital health regulatory expert Jamie Hatzel, we talk about artificial intelligence. Specifically, we discuss what happens to Software as a Medical Device within incoming EU artificial intelligence legislation, which has now entered trilogue negotiations. Issues such as the meaning of “high risk” within the proposed AI Act, in contrast to its meaning in the existing Medical Device Regulations, highlight the importance for manufacturers in this space or thinking about entering it of getting good advice, Hatzel points out.

Audio roundup of selected biopharma industry content from Scrip over the past business week.

https://scrip.pharmaintelligence.informa.com/SC148825/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporters and editors and special guests from 3D Communications, a firm that helps sponsors prepare for advisory committee meetings, dig into the pros and cons of issues such as eliminating or reducing advisory committee votes (1:15), creating more time for committee discussion (10:25), committee member preparation (19:25), adding more temporary members (25:35), and in-person versus virtual meetings (30:45). They also discuss industry’s reaction to the reform campaign (39:10) and a roadmap for implementing changes (41:10).

Read More On Advisory Committee Reform From The Pink Sheet

US FDA Chief Scientist Wants To Make Advisory Committee Participation Easier: https://pink.pharmaintelligence.informa.com/PS148640/US-FDA-Chief-Scientist-Wants-To-Make-Advisory-Committee-Participation-Easier

US FDA Center Directors Should Not Influence Adcomm Votes Or Overrule Scientific Staff, Coalition Says: https://pink.pharmaintelligence.informa.com/PS148566/US-FDA-Center-Directors-Should-Not-Influence-Adcomm-Votes-Or-Overrule-Scientific-Staff-Coalition-Says

Expect More Temporary Members Voting In US FDA Advisory Committees: https://pink.pharmaintelligence.informa.com/PS148243/Expect-More-Temporary-Members-Voting-In-US-FDA-Advisory-Committees

US FDA Adcomm Modernization Includes How Meetings Are Scheduled: https://pink.pharmaintelligence.informa.com/PS144678/US-FDA-Adcomm-Modernization-Includes-How-Meetings-Are-Scheduled

Power To The (Adcomm) People: Members Believe Votes Should More Directly Affect US FDA Decisions: https://pink.pharmaintelligence.informa.com/PS144679/Power-To-The-Adcomm-People-Members-Believe-Votes-Should-More-Directly-Affect-US-FDA-Decisions

US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion: https://pink.pharmaintelligence.informa.com/PS144485/US-FDA-Advisory-Committees-Could-Get-Revamp-With-A-Focus-On-Science-Over-Emotion

US FDA Advisory Committees' Future: Drug-Agnostic Panels, More Debate Time: https://pink.pharmaintelligence.informa.com/PS147757/US-FDA-Advisory-Committees-Future-DrugAgnostic-Panels-More-Debate-Time

US FDA Advisory Committee Formats Can Spur Unhealthy Dynamics – Califf: https://pink.pharmaintelligence.informa.com/PS148397/US-FDA-Advisory-Committee-Formats-Can-Spur-Unhealthy-Dynamics--Califf

How The Eudamed Medical Device Database Is Progressing Slowly But Surely And the Challenges Ahead