Citeline Podcasts

Over The Counter 9 June 2023: Embracing AI/AR Evolution In Beauty, While Navigating Its Hurdles by Citeline

In this episode, MedTech Insight regulatory reporter speaks to Erez Kaminski, CEO and founder of Ketryx, which assists clients in creating FDA-regulated software. He updates us on the latest and greatest in digital health regulations, including PCCPs, decentralized clinical trials and AI/ML software. We talk about some of the challenges and opportunities that often arise from these regulations and Erez shares a personal story about why the safety of medical devices matters so much to him.

점점 더 많은 미국과 아시아계 제약바이오 기업들이 스위스에 EU 본부를 설립하고 있는 배경에 대한 Scrip 기사를 요약한 내용입니다.

https://scrip.pharmaintelligence.informa.com/SC148478/From-Hengrui-To-Moderna-Why-More-Biotech-Companies-Are-Creating-Swiss-Hubs

Quick Listen: Scrip's Five Must-Know Things

https://scrip.pharmaintelligence.informa.com/SC148490/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporters and editors discuss CMS’s latest coverage announcement for Alzheimer’s drugs and the VA’s approach to the issue (0:29), the FDA’s new one-page patient medication information document (15:55), international convergence on COVID-19 vaccine strain selection (24:48), and Novavax’s place in the vaccine toolbox going forward (28:21).

Read More In The Pink Sheet

Medicare Registry Plan For Alzheimer’s Drugs Pairs CMS Web Portal With Health System Efforts

https://pink.pharmaintelligence.informa.com/PS148313/Medicare-Registry-Plan-For-Alzheimers-Drugs-Pairs-CMS-Web-Portal-With-Health-System-Efforts

The US VA And Alzheimer’s: A Misunderstood Decision

https://pink.pharmaintelligence.informa.com/PS148214/The-US-VA-And-Alzheimers-A-Misunderstood-Decision

One-Page Patient Medication Information Document Moves Forward Under Proposed Rule

https://pink.pharmaintelligence.informa.com/PS148298/One-Page-Patient-Medication-Information-Document-Moves-Forward-Under-Proposed-Rule

International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine

https://pink.pharmaintelligence.informa.com/PS148301/International-Regulators-Focus-On-Omicron-XBB-For-Monovalent-COVID-19-Vaccine

Novavax Readying Multiple COVID-19 Vaccine Candidates To Ensure Fall Availability

https://pink.pharmaintelligence.informa.com/PS148261/Novavax-Readying-Multiple-COVID-19-Vaccine-Candidates-To-Ensure-Fall-Availability

NSCLC Disease Analysis Report

https://service.datamonitorhealthcare.com/hkc/disease/oncology/lung-cancer/non-small-cell-lung-cancer/disease-analysis/article218222.ece

NSCLC Forecast

https://service.datamonitorhealthcare.com/hkc/disease/oncology/lung-cancer/non-small-cell-lung-cancer/forecast/article141043.ece

HER2+ Breast Cancer Disease Analysis Report

https://service.datamonitorhealthcare.com/hkc/disease/oncology/gynecological-cancer/breast-cancer-her2-positive/disease-analysis/article213383.ece

HER2+ Breast Cancer Forecast

https://service.datamonitorhealthcare.com/hkc/disease/oncology/gynecological-cancer/breast-cancer-her2-positive/forecast/article108428.ece

Other platforms

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

Regulatory strategists present key publishing strategies to consider when planning your marketing application for successful regulatory outcomes.

Don’t miss insights into creating your strongest marketing application strategy, with guidelines from experts at Veristat.

You’ll learn more about the important steps to follow for:

• Building a publishing-specific team and educating stakeholders about the document submission process

• Creating an effective communication strategy

• Mitigating delays

• Understanding timelines

• And much more

Successfully navigate the complexities of the Chemical, Manufacturing, and Controls (CMC) portions of Investigational New Drug (IND) applications.

Listen in as experts provide their insider perspectives on common CMC- and IND- related questions.

Listen to expert perspectives on the recent history of DEI in clinical trials and the barriers to patient participation.

Listen now to a lively and informative discussion that addresses the questions:

• What has changed in patient recruitment strategies from pre- to post-COVID and why?

• What factors influenced a new focus on DEI during the time of COVID?

• What are the barriers to DEI for patient recruitment in Phase I and Phase II studies?

• And more

Quick Listen: Scrip's Five Must-Know Things

https://scrip.pharmaintelligence.informa.com/SC148456/Quick-Listen-Scrips-Five-MustKnow-Things