Summary

In this episode, Shivu and Kenny review their predictions for 2025 and make new predictions for 2026. They discuss trends in mergers and acquisitions, market performance, the impact of AI in drug development, and the rise of digital advertising in the pharmaceutical industry. They also explore the evolving landscape of biotech companies, regulatory changes from the FDA, and the growing interest in metabolic diseases and psychedelics. Finally, they introduce the 'pharm to table' model in pharma, emphasizing direct-to-patient commercial channels and how these increase patient agency.

Chapters

00:00 Introduction and Overview of Predictions

04:37 Grading 2025 Predictions

10:35 Shivu's 2025 Predictions and Grades

16:53 2026 Predictions: Emerging Trends

22:50 Regulatory Landscape and the FDA's Role

30:46 Predictability in Drug Approval Processes

30:51 The Metabolic Space and GLP-1s

33:08 Big Pharma's Entry into Obesity and Diabetes

34:56 The Risk of Commoditization in Drug Markets

37:06 Differentiation in the GLP-1 Market

39:40 The Rise of Psychedelics in Psychiatry

47:21 Pharm-to-Table Model in Pharma

54:06 Empowering Patients through Direct Access

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DISCLAIMER: The views and opinions expressed in this podcast are for informational and educational purposes only. They are not intended as medical advice and should not be used as a substitute for professional medical judgment or guidance. Always consult a qualified healthcare provider with any questions you may have regarding a medical condition or treatment.

SUMMARY

In this deep dive into biopharma M&A trends, Shivu and Kenny analyze 10 years of acquisition data from major pharma players, revealing rising deal volumes and the increasing prevalence of Contingent Value Rights (CVRs) as risk mitigation tools. The hosts dissect the unprecedented Pfizer-Novo bidding war over Metsera, examining how this “interloper” situation reflects broader industry dynamics around patent cliffs and portfolio diversification strategies. The episode provides insider perspectives on why investors never seem satisfied with “enough” M&A activity and how companies balance internal R&D with external acquisitions in their portfolio approach.

CHAPTERS

00:00 Introduction to M&A in Biopharma

03:35 Understanding Contingent Value Rights (CVRs)

06:47 Recent M&A Deals and Trends

13:17 Impact of Patent Cliffs on M&A Activity

17:43 The Portfolio Approach to Drug Development

22:00 Current Trends in Deal Volume and CVR Usage

28:58 Valuation Trends in Late-Stage Companies

32:51 The Buyer-Seller Dynamic in Pharma Deals

38:27 Evaluating CVRs and Acquirer Capabilities

42:31 GenMab’s Strategic Acquisition and Market Positioning

48:11 The Rise of the Biotech Middle Class

55:49 The Aggressive Landscape of Pharma Hiring

56:56 Innovation in RNA Interventions

57:53 The Metsera Bidding War Begins

01:00:11 Pfizer’s Acquisition Strategy Unfolds

01:03:48 Regulatory Implications and Government Influence

01:07:41 The Future of Metabolic Disease Treatments

01:10:27 Interloper Behavior in Pharma Acquisitions

01:15:35 The Role of Government Relationships in Pharma

01:19:05 Concluding Thoughts on M&A Trends

01:22:14 OUTRO

DOWNLOADS:

• M&A and CVR analysis available here

CONTACT US:

• Questions? Emal us at: ⁠⁠drugdealinpod@gmail.com⁠⁠
• Follow ⁠Shivu on X⁠
• Sign up for Shivu's newsletter: Big Pharma Sharma⁠ ⁠
• Follow ⁠Kenny⁠

DISCLAIMER: The views and opinions expressed in this podcast are for informational and educational purposes only. They are not intended as medical advice and should not be used as a substitute for professional medical judgment or guidance. Always consult a qualified healthcare provider with any questions you may have regarding a medical condition or treatment.

SUMMARY: In this episode, Shivu and Kenny discuss the recent developments surrounding Replimune and its interactions with the FDA. They explore the implications of leadership changes at the FDA, the importance of patient advocacy, and the challenges faced by small biotech companies in navigating the regulatory landscape. The conversation highlights the critical role of stability in drug approvals and the potential impact on patient care, particularly in oncology. They discuss the complexities of the FDA's role in drug development, the importance of confirmatory studies, and the impact of leadership changes on regulatory processes. They also talk about the historical evolution of the FDA, its commitment to patient safety, and the challenges it faces in maintaining consistency and transparency. The conversation culminates in a thought-provoking discussion on the potential benefits of an independent FDA, akin to the Federal Reserve, to enhance trust and efficacy in drug approvals.

DISCLAIMER: The views and opinions expressed in this podcast are for informational and educational purposes only. They are not intended as medical advice and should not be used as a substitute for professional medical judgment or guidance. Always consult a qualified healthcare provider with any questions you may have regarding a medical condition or treatment.

CHAPTERS:

00:00 The FDA's Independence and Scope

02:53 Timeline of Instability at the FDA

14:00 Impact of Instability on Drug Development

19:54 Case Study: RepliMune's Regulatory Journey

34:00 Navigating FDA Interactions and Accelerated Approvals

58:03 The Role of a Healthy FDA: History and Function

01:12:40 Organizational Culture and Stability in Regulatory Agencies

01:15:24 Navigating Institutional Changes at the FDA

01:18:45 The Importance of Consistency in Health Guidelines

01:22:27 Transparency and Data Disclosure in Drug Approvals

01:25:18 The Case for an Independent FDA

01:29:53 Lessons from the Federal Reserve's Independence

01:35:11 Engendering Trust in Health Institutions

01:41:49 Final Thoughts

CONTACT US:

• Questions?: ⁠⁠drugdealinpod@gmail.com⁠⁠
• Follow us on X
• Follow Shivu on X
• Subscribe to Shivu's newsletter, Big Pharma Sharma ⁠⁠
• Follow Kenny