Citeline Podcasts

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: US Medicare price negotiations get soft landing; Medicare negotiations and patent cliff acceleration; Novo Nordisk steps into heart failure; PCSK9s and the convenience battle; and an investor’s view of Korean biotech potential.

https://scrip.pharmaintelligence.informa.com/SC148990/Quick-Listen-Scrips-Five-MustKnow-Things

Summary:

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.

Medtech Insight articles addressing topics discussed in this episode:

GaitBetter On Mission To Bring VR, AI-Based Solution To Gait Training; Will Physical Therapists Pay For It?

ReWalk Robotics’ Planned Acquisition Of Anti-Gravity Maker AlterG For $19M Paves Way To Profitability

NIST Cybersecurity Framework 2.0 Expands Guidance’s Scope, Introduces ‘Govern’ Function

Vulnerabilities Up 59%: The State Of Healthcare Cybersecurity In 2023

Cybersecurity Expert Says eSTAR Requirement Will Push FDA, Industry In Positive Direction

Pink Sheet reporters and editors consider lessons and next steps after the first list of drugs subject to Medicare price negotiations was released (:34) and discuss Oncopeptides’ Pepaxto facing withdrawal under the US FDA’s new and potentially faster process (22:44).

More On The Medicare Price Negotiation List From The Pink Sheet

Litigation Against Medicare Price Negotiation Gains Four Potential New Plaintiffs: https://pink.pharmaintelligence.informa.com/PS148778/Litigation-Against-Medicare-Price-Negotiation-Gains-Four-Potential-New-Plaintiffs

Medicare Negotiation List Surprises Highlight The Importance Of Current Spending Data: https://pink.pharmaintelligence.informa.com/PS148781/Medicare-Negotiation-List-Surprises-Highlight-The-Importance-Of-Current-Spending-Data

Patent Cliff Likely Accelerated By Two Years For Most Drugs On Medicare Price Negotiation List: https://pink.pharmaintelligence.informa.com/PS148775/Patent-Cliff-Likely-Accelerated-By-Two-Years-For-Most-Drugs-On-Medicare-Price-Negotiation-List

Price Negotiation Purgatory: Upcoming Biosimilars Couldn’t Keep Stelara, NovoLog Off The List: https://pink.pharmaintelligence.informa.com/PS148776/Price-Negotiation-Purgatory-Upcoming-Biosimilars-Couldnt-Keep-Stelara-NovoLog-Off-The-List

Timetable For Medicare Price Negotiation Of The First 10 Drugs (And Beyond): https://pink.pharmaintelligence.informa.com/PS148760/Timetable-For-Medicare-Price-Negotiation-Of-The-First-10-Drugs-And-Beyond

CMS Seeking Patient Comments On Negotiated Drugs Similar To US FDA’s PFDD Program: https://pink.pharmaintelligence.informa.com/PS148773/CMS-Seeking-Patient-Comments-On-Negotiated-Drugs-Similar-To-US-FDAs-PFDD-Program

Big Rebates Already A Big Factor For Drugs On Medicare Negotiation List:

https://pink.pharmaintelligence.informa.com/PS148774/Big-Rebates-Already-A-Big-Factor-For-Drugs-On-Medicare-Negotiation-List

Price Negotiation And The GLP1 Class: Trulicity Lucky To Be A BLA: https://pink.pharmaintelligence.informa.com/PS148794/Price-Negotiation-And-The-GLP1-Class-Trulicity-Lucky-To-Be-A-BLA

More On The Pepaxto Withdrawal From The Pink Sheet

To Save Pepaxto, Oncopeptides Throws Shade At IMiD Use In Elderly Myeloma Patients: https://pink.pharmaintelligence.informa.com/PS148770/To-Save-Pepaxto-Oncopeptides-Throws-Shade-At-IMiD-Use-In-Elderly-Myeloma-Patients

How Fast Is ‘Expedited’? Pepaxto To Show Speed Of New Withdrawal Process For Accelerated Approval Drugs: https://pink.pharmaintelligence.informa.com/PS148766/How-Fast-Is-Expedited-Pepaxto-To-Show-Speed-Of-New-Withdrawal-Process-For-Accelerated-Approval-Drugs

FDA’s Pepaxto Decider: Peter Marks To Handle Oncopeptides’ Appeal Of Accelerated Approval Withdrawal: https://pink.pharmaintelligence.informa.com/PS148761/FDAs-Pepaxto-Decider-Peter-Marks-To-Handle-Oncopeptides-Appeal-Of-Accelerated-Approval-Withdrawal

Hua Medicine’s founder and CEO Li Chen discusses with host Brian Yang about its new product launch for dorzagliatin, glucokinase activator for type 2 diabetes in China, partnership with Bayer, and plans to get reimbursed through National Reimbursement Drug List.

https://scrip.pharmaintelligence.informa.com/SC148981/Hua-Medicines-Chen-On-Product-Launch-Bayer-Partnership-And-Reimbursement

Scrip’s senior editor Vibha Ravi speaks with Dr Thomas Rademacher, Emergex CEO and ex-research director at the University of Oxford, about the myth of the “Wuhan virus” and why synthetic T-cell adaptive vaccines are expected to be superior to RNA/mRNA ones. Novel delivery mechanisms like patches and microneedles are part of the UK-based clinical-stage biotech’s plan to make universal coronavirus and influenza vaccines affordable and effective as it seeks to partner governments.

https://scrip.pharmaintelligence.informa.com/SC148976/Emergex-CEO-Questions-mRNA-Vaccines-Against-Wuhan-Virus-Works-On-Universal-Vaccines

Listen in as experts from Advanced Clinical discuss the evolution of the decentralized clinical trial model and what it means in a post-COVID landscape. Experts from Advanced Clinical share their thoughts on the benefits, challenges, management considerations, and outlook for such trials in this short podcast, packed with operational insights.

In this episode, HBW Insight talks to BSS Consulting’s Birgit Schuhbauer about her stellar career in consumer healthcare. Up until recently, Schuhbauer was global vice president for Johnson & Johnson’s Self Care Franchise and president of the Association of the European Self-Care Industry. Now setting up on her own, Schuhbauer reflects on her career highlights, what it takes to be a leader in OTC and on her role as the AESGP’s first female president during a time of unprecedented change.

Mithra is shaking up the stagnant women’s health market with a brand new estrogenic compound. E4, or estetrol, is a natural estrogen produced by the human fetus during pregnancy, and could represent a major breakthrough in contraceptive and menopause care.

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Roche’s TIGIT data leak; Regeneron gets important US approvals; COVID subvariant vaccine progress; Pfizer’s RSV vaccine extended approval; and Japan recommends lecanemab for Alzheimer’s.

https://scrip.pharmaintelligence.informa.com/SC148952/Quick-Listen-Scrips-Five-MustKnow-Things

In this Chinese-language podcast, Brian Yang and Dexter Yan discuss the latest hot topics in August in China’s biotech sector, which include a massive anti-corruption campaign and PD-1 inhibitor antibody development and approval prospects in the US.

https://scrip.pharmaintelligence.informa.com/SC148929/ChineseLanguage-Podcast-AntiCorruption-Campaign-PD1-Going-Global