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

Pink Sheet reporters and editors discuss the largest pharma companies’ pending applications (0:41), the FDA delaying its decision on Sarepta’s gene therapy in Duchenne muscular dystrophy (14:32), and a plan to add more temporary members to agency advisory committees (24:55) … as well as a little bit of “The Simpsons.”

Read More In The Pink Sheet

Everything’s Coming Up Pfizer: The Biggest Of Pharma Firms Leads Industry In Pending Applications For US FDA Approval

https://pink.pharmaintelligence.informa.com/PS148271/Everythings-Coming-Up-Pfizer-The-Biggest-Of-Pharma-Firms-Leads-Industry-In-Pending-Applications-For-US-FDA-Approval

Big Pharma At US FDA: A Regulatory Scorecard

https://pink.pharmaintelligence.informa.com/PS148265/Big-Pharma-At-US-FDA-A-Regulatory-Scorecard

Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters

https://pink.pharmaintelligence.informa.com/PS148280/Lilly-Unlucky-Lilly-Leads-Big-Pharma-In-US-FDA-Complete-Response-Letters

Everybody Stumbles: US FDA Complete Response Letters To Big Pharma

https://pink.pharmaintelligence.informa.com/PS148279/Everybody-Stumbles-US-FDA-Complete-Response-Letters-To-Big-Pharma

Sarepta’s DMD Gene Therapy: Approval Delayed And Indication Narrowed, But Still On Track

https://pink.pharmaintelligence.informa.com/PS148268/Sareptas-DMD-Gene-Therapy-Approval-Delayed-And-Indication-Narrowed-But-Still-On-Track

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

HBW Insight catches up with our own US Executive Editor, Malcolm Spicer, to find out all about Perrigo subsidiary HRA Pharma’s Rx-to-OTC switch of its daily contraceptive, Opill. Currently under consideration by the US Food and Drug Administration after a positive recommendation from its advisory committees, Spicer draws on 30+ years of writing about the US consumer healthcare market, as well as his extensive coverage of the subject, to tell us all we need to know about this historic switch.

Quick Listen: Scrip's Five Must-Know Things

https://scrip.pharmaintelligence.informa.com/SC148417/Quick-Listen-Scrips-Five-MustKnow-Things

Brian Yang and Dexter Yan discuss the latest China biotech trends and topics including recent mega-million deals between domestic biotechs and MNCs, the inaugural Asia Bio Partnering Forum and drug makers’ creative ways to financing amid lingering “capital winter”, and GLP-1 receptor agonists stepping into the spotlight and its potential to become the next hot pursuit after PD-1 in China.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb discusses how two medtech CEOs are and aren’t using ChatGPT in their businesses while Reed Miller talks about his “Cardio Conversations” podcast interviews with Quentin Blackford, CEO of iRhythm and Rob Krummen, CEO of Vektor Medical. Washington, DC-based reporter Hannah Daniel reviews highlights from the HIMSS conference and the latest updates on FDA guidances.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

Cardio Conversations: iRhythm Prepares To Deliver ‘Standard-Of-Care’ Cardiac Monitoring

Cardio Conversations: Vektor Addresses ‘Global Health Crisis’ With Arrythmia Mapping

HIMSS23

Using The Metaverse To Break Down Language Barriers and Improve Diversity In Clinical Trials

Tales From HIMSS23: FDA On FHIR And AI For The Voiceless

Decentralized Clinical Trial Guidance Fulfills Promise, Underlies Digitization Of Healthcare

Expert: FDA’s Highly Anticipated PCCP Guidance Isn’t Anything Too ‘Surprising’

How Two Medtech CEOs Are (And Aren’t) Using ChatGPT In Their Businesses