Ep. 343 - JPM Deals, Policy Outlook, Approval Trends | BioCentury This Week

The podcast opens with a discussion on the JP Morgan conference and potential M&A activities, including rumors around Abivax and RevMed. It shifts to recent deal activity, such as AbbVie's acquisition of a Remagen bi-specific asset, with an analysis of its value relative to similar deals. The conversation explores new co-deals, highlighting Hisco and AirNexus, and the investors involved. The discussion then turns to policy and FDA outlook for 2026, addressing concerns about political influence on regulatory decisions and drug pricing. Finally, the speakers analyze FDA approvals in 2025, noting a slight decrease in new drug approvals but consistent innovation metrics, while also considering the potential impact of policy changes on future approvals, particularly for orphan drugs.

Outlines

Part 1: JP Morgan, M&A, and Market Rumors

Part 2: Innovation Pipelines and New Ventures

Part 3: Policy, FDA Regulation, and Drug Pricing

Part 4: Approval Metrics and Future Trends

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Ep. 343 - JPM Deals, Policy Outlook, Approval Trends

BioCentury This Week

Part 1: JP Morgan, M&A, and Market Rumors

JP Morgan Monday in San Francisco: Deal Rumors and East-West Summit

Pre-JP Morgan Deals and Rumored Acquisitions of RevMed and Abivax

AbbVie's Acquisition of Remagen's PD-1 VEGF Bi-Specific Antibody

Comparing Bi-Specific Deals and the Rise of China in Biopharma

Part 2: Innovation Pipelines and New Ventures

Hisco's Innovative Pipeline and Merck's Verona Acquisition

AirNexus NuCo Investors and a Quick Break

Part 3: Policy, FDA Regulation, and Drug Pricing

Policy and FDA Outlook for 2026: Road Work Ahead

Dissonance at FDA and Potential PDUFA Date Slippage

Reshaping U.S. Drug Pricing Landscape with MFN Agreements

CMS's GENEROUS Model and Mandatory MFN Models

Part 4: Approval Metrics and Future Trends

FDA Approval Numbers and Innovation Metrics

Accelerated Approvals and Focus on Formulation and Delivery

Orphan Drug Approvals and Podcast Closing

Ep. 343 - JPM Deals, Policy Outlook, Approval Trends

BioCentury This Week

Part 1: JP Morgan, M&A, and Market Rumors

00:01JP Morgan Monday in San Francisco: Deal Rumors and East-West Summit

JP Morgan Monday in San Francisco: Deal Rumors and East-West Summit

01:57Pre-JP Morgan Deals and Rumored Acquisitions of RevMed and Abivax

Pre-JP Morgan Deals and Rumored Acquisitions of RevMed and Abivax

04:17AbbVie's Acquisition of Remagen's PD-1 VEGF Bi-Specific Antibody

AbbVie's Acquisition of Remagen's PD-1 VEGF Bi-Specific Antibody

05:52Comparing Bi-Specific Deals and the Rise of China in Biopharma

Comparing Bi-Specific Deals and the Rise of China in Biopharma

Part 2: Innovation Pipelines and New Ventures

07:36Hisco's Innovative Pipeline and Merck's Verona Acquisition

Hisco's Innovative Pipeline and Merck's Verona Acquisition

10:03AirNexus NuCo Investors and a Quick Break

AirNexus NuCo Investors and a Quick Break

Part 3: Policy, FDA Regulation, and Drug Pricing

11:49Policy and FDA Outlook for 2026: Road Work Ahead

Policy and FDA Outlook for 2026: Road Work Ahead

13:55Dissonance at FDA and Potential PDUFA Date Slippage

Dissonance at FDA and Potential PDUFA Date Slippage

15:23Reshaping U.S. Drug Pricing Landscape with MFN Agreements

Reshaping U.S. Drug Pricing Landscape with MFN Agreements

17:26CMS's GENEROUS Model and Mandatory MFN Models

CMS's GENEROUS Model and Mandatory MFN Models

Part 4: Approval Metrics and Future Trends

19:30FDA Approval Numbers and Innovation Metrics

FDA Approval Numbers and Innovation Metrics

21:15Accelerated Approvals and Focus on Formulation and Delivery

Accelerated Approvals and Focus on Formulation and Delivery

24:45Orphan Drug Approvals and Podcast Closing

Orphan Drug Approvals and Podcast Closing