Biopharma Deals 2024

Key Biopharma Deals of 2024

Trends, Insights, and Strategic Implications The biopharma industry in 2024 experienced a transformative year marked by high-value mergers and acquisitions (M&A), strategic licensing agreements, significant investments in radiopharmaceuticals, and an…
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Biopharma Deals 2024

Key Biopharma Deals of 2024

Trends, Insights, and Strategic Implications The biopharma industry in 2024 experienced a transformative year marked by high-value mergers and acquisitions…
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Welcome

KYBORA Welcomes Stefan Bluemmers as Managing Director

Princeton, NJ – January 13, 2025 – KYBORA, a global healthcare advisory firm and investment bank, is proud to announce that Stefan…
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Accelerated Approval PRV

Accelerated Approval (AA) and PRV Grant: Implications of the FDA’s Updated Guidance

Executive Summary – The U.S. Food and Drug Administration (FDA)’s December 2024 guidance,“Expedited Program for Serious Conditions – Accelerated Approval…
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KYBORA's Charitable Work

Empowering Dreams through Foundation Rwanda’s KYBORA Program

Ange's Entrepreneurial Spirit Shines Bright Ange's journey is one of perseverance and hope. After gaining extensive experience in the liquor…
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Navigating the Complexities of PRVs in the Context of AA Withdrawals

Navigating the Complexities of Priority Review Vouchers in the Context of Accelerated Approval Withdrawals

Executive Summary – The FDA’s Accelerated Approval (AA) pathway has been instrumental inexpediting treatments for serious conditions, but recent scrutiny,…
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Recent Facts & Figures related to Priority Review Vouchers Value - 2020 to 2024

Recent Facts & Figures related to Priority Review Vouchers Value – 2020 to 2024

Executive Summary – As the year draws to a close, we present an updated analysis of the Priority Review Vouchers…
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European Pharma Group Proposes TEE Voucher System to Revitalize Antibiotics R&D

European Pharma Group Proposes TEE Voucher System to Revitalize Antibiotics R&D

Executive Summary – The European pharmaceutical industry is advocating for the implementation of a Transferable Exclusivity Extension (TEE) system to…
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KYBORA Advises Xbrane on Global Licensing Agreement with Intas

KYBORA Advises Xbrane on Global Licensing Agreement with Intas

KYBORA, a leading global advisory firm specializing in biopharma transactions, served as the exclusiveadvisor to Xbrane Biopharma AB (Nasdaq Stockholm:…
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Navigating Priority Review Voucher Eligibility: Beyond Rare Pediatric Disease Designation

Navigating Priority Review Voucher Eligibility: Beyond Rare Pediatric Disease Designation

Executive Summary – A pediatric drug can qualify for a Priority Review Voucher (PRV) upon FDAapproval, even without receiving a…
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Understanding the Role of the Not Same Active Moiety Principle in RPDD and PRV Evaluations

Executive Summary – The FDA’s “not same active moiety” principle plays a key role in evaluating eligibility for Rare Pediatric…
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The latest trends on biotech companies with negative enterprise values

The Latest Trends on Biotech Companies with Negative Enterprise Values: Insights and Implications

In the post Covid era, the spotlight turned sharply towards biotech companies with negative enterprise value (EV). While many saw…
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KYBORA Advises Lupin

KYBORA Advises Lupin on the Divestiture of U.S. Commercial Women’s Health Specialty Business to Evofem

Global pharma major Lupin announced that it has divested its U.S. Commercial Women's Health Specialty Business to Evofem Biosciences, a U.S.…
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