Executive Summary – The U.S. Food and Drug Administration (FDA)’s December 2024 guidance,“Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics”, refines theAccelerated Approval (AA) pathway, emphasizing timely initiation and completion of confirmatorytrials to verify clinical benefits. It stresses the need for early engagement with the FDA to determineappropriate surrogate or intermediate […]
Ange’s Entrepreneurial Spirit Shines Bright Ange’s journey is one of perseverance and hope. After gaining extensive experience in the liquor store industry, she decided to pursue her own dream by opening Unique One Shop, with a small loan of $500 from Foundation Rwanda . However, when COVID-19 struck, her new business faced immense challenges. Instead […]
Executive Summary – The FDA’s Accelerated Approval (AA) pathway has been instrumental inexpediting treatments for serious conditions, but recent scrutiny, as highlighted in the BioSpace article, FDA’s Accelerated Approval Pathway Under Fire, raises questions about its sustainability and oversight. Only about half of AA drugs convert to full approval, creating uncertainty for associated incentives like […]
Executive Summary – As the year draws to a close, we present an updated analysis of the Priority Review Vouchers (PRV) market, which has recently experienced a notable surge in value. From 2020 to November 2024, 46 PRVs were granted throughout the three categories (37 for pediatric rare diseases, 7 for medical counter-measures, and 2 […]
Executive Summary – The European pharmaceutical industry is advocating for the implementation of a Transferable Exclusivity Extension (TEE) system to address the critical challenge of antimicrobial resistance (AMR). Modeled after the Priority Review Voucher (PRV) system in the U.S., the TEE mechanism offers a powerful market-based incentive for companies to invest in the development of […]
KYBORA, a leading global advisory firm specializing in biopharma transactions, served as the exclusiveadvisor to Xbrane Biopharma AB (Nasdaq Stockholm: XBRANE; “Xbrane”) in securing a landmarkglobal licensing and co-development agreement with Intas Pharmaceuticals Ltd (“Intas”). This agreementcenters on the development and commercialization of Xbrane’s nivolumab biosimilar candidate,referencing Opdivo®. Under the agreement, Intas, through its subsidiary […]
Executive Summary – A pediatric drug can qualify for a Priority Review Voucher (PRV) upon FDAapproval, even without receiving a Rare Pediatric Disease Designation (RPDD). While RPDD is acommon route to PRV eligibility, it is not the only pathway. This article outlines the criteria for PRVeligibility, emphasizing the need for a designation for a rare […]
Executive Summary – The FDA’s “not same active moiety” principle plays a key role in evaluating eligibility for Rare Pediatric Disease Designation (RPDD) and Priority Review Vouchers (PRV), with different levels of scrutiny applied at each stage. While RPDD primarily assesses whether a drug addresses a rare pediatric condition and shows potential efficacy, it does […]
In the post Covid era, the spotlight turned sharply towards biotech companies with negative enterprise value (EV). While many saw them as good potential reverse merger targets, few of these transactions occurred. A detailed analysis over the past five years reveals important trends and lessons about this phenomenon. As the industry evolves, focusing on genuine […]
Global pharma major Lupin announced that it has divested its U.S. Commercial Women’s Health Specialty Business to Evofem Biosciences, a U.S. biopharmaceutical company focused exclusively on Women’s Health.Lupin’s U.S. Commercial Women’s Health Specialty Business is primarily focused on commercializing SOLOSEC® (secnidazole) 2g oral granules. This FDA-approved single-dose antimicrobial agent provides a complete course of therapy for […]
