Cell and Gene Regulatory
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Hope For People With Spinocerebellar Ataxia
6/24/2025
Spinocerebellar ataxia (SCA) is a rare, progressive, and fatal neurodegenerative disease with no approved treatments, but Biohaven Pharmaceuticals’ new drug troriluzole — designed to modulate glutamate and slow disease progression — has shown promise in clinical trials and is currently under FDA review, offering hope to patients and families facing this devastating disorder.
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Accelerate Biologics Product Release With Seamless Viral Testing
6/23/2025
Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.
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Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
6/23/2025
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
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How Is RIM Software Transforming Regulatory Compliance?
6/20/2025
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
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FDA Trials And Tribulations With Connect Biopharma's Barry Quart
6/19/2025
On this week's episode of the Business of Biotech, Barry Quart, CEO of Connect Biopharma, weighs in on the current state of engagement between drug developers and the FDA, and how that key relationship continues to evolve under new leadership. Barry also discusses moving the company from China to San Diego, why a U.S. financial reporting structure helps attract investors, and how Connect is finding the white spaces in respiratory disease -- the company's lead candidate is a biologic drug targeting acute asthma and COPD exacerbations.
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EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?
6/19/2025
On July 1, 2025, the EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials is slated to come into effect.
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Closed-Loop Manufacturing Is The Cell Therapy Revolution We Need
6/18/2025
In cell therapy manufacturing, automated closed systems with integrated software controls offer numerous benefits over traditional open systems.
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Exploring The Market For Closed-Loop Cell Therapy Production
6/18/2025
The second part of a discussion on closed-loop systems explores the CDMO and equipment landscape for scaling automated closed loop cell therapy manufacturing systems.
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Extracellular Vesicle Breakthroughs with Aegle Therapeutics' Dr. Gloria Matthews
6/17/2025
In this episode of Cell & Gene: The Podcast, Host Erin Harris interviews Dr. Gloria Matthews, Chief Medical Officer of Aegle Therapeutics, a clinical-stage regenerative medicine company focused on developing therapies for rare and severe dermatologic and immunologic disorders.
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What Global Survey Says About Scant Patient Access To CAR-T Therapy
6/17/2025
The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.