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Avantor Expands U.S. Biomanufacturing with New Testing Facility in St. Louis

Avantor Expands U.S. Biomanufacturing with New Testing Facility in St. Louis

Avantor Expands U.S. Biomanufacturing with New Testing Facility in St. Louis
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Cell and Gene Therapy CDMO Market Projected to Reach $125 Billion by 2035

Cell and Gene Therapy CDMO Market Projected to Reach $125 Billion by 2035

Cell and Gene Therapy CDMO Market Projected to Reach $125 Billion by 2035
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Parabilis Medicines Strengthens Leadership with Key Appointments to Drive Growth

Parabilis Medicines Strengthens Leadership with Key Appointments to Drive Growth

Parabilis Medicines Strengthens Leadership with Key Appointments to Drive Growth
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WuXi Biologics Achieves ISO 13485 Certification, Enhancing Drug-Device Product Development

WuXi Biologics Achieves ISO 13485 Certification, Enhancing Drug-Device Product Development

WuXi Biologics Achieves ISO 13485 Certification, Enhancing Drug-Device Product Development
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Regeneron Pharmaceuticals Faces Critical Juncture Amid Patent Cliff and New Frontiers

Regeneron Pharmaceuticals Faces Critical Juncture Amid Patent Cliff and New Frontiers

Regeneron Pharmaceuticals Faces Critical Juncture Amid Patent Cliff and New Frontiers
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Sweden blames pro-Russian group for cyberattack last year on its energy infrastructure

Sweden blames pro-Russian group for cyberattack last year on its energy infrastructure

The Swedish government says a pro-Russian actor was behind a cyberattack on a heating plant in western Sweden last year
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Israel Invests in Bioconvergence to Drive Economic Growth Across Multiple Sectors

Israel Invests in Bioconvergence to Drive Economic Growth Across Multiple Sectors

Israel is positioning bioconvergence as a new economic growth engine, investing heavily in research, infrastructure, and regulation. The National Bioconvergence Program, with a budget of approximately $145 million for its first phase (2023-2027), aims to integrate biology with other technological disciplines such as engineering and computational science. The initiative, led by multiple government bodies, seeks to expand bioconvergence applications beyond healthcare into agriculture, food, industry, energy, and the environment. As of October 2025, Israel had mapped 188 active bioconvergence companies, with significant investments in multidisciplinary R&D infrastructure and human capital development.
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EyePoint's DURAVYU Phase 3 Progress and Manufacturing Expansion Boosts Valuation

EyePoint's DURAVYU Phase 3 Progress and Manufacturing Expansion Boosts Valuation

EyePoint's DURAVYU Phase 3 Progress and Manufacturing Expansion Boosts Valuation
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FDA Introduces New Safety Guidelines for Gene Editing Therapies to Accelerate Development

FDA Introduces New Safety Guidelines for Gene Editing Therapies to Accelerate Development

The FDA has released new draft safety guidelines aimed at standardizing the evaluation of genome editing therapies. These guidelines are designed to support the development of both ex vivo and in vivo gene editing products, with a focus on next-generation sequencing techniques to identify potential off-target effects. The initiative is part of the FDA's broader effort to expedite the development of personalized therapies, particularly for ultra-rare diseases. The guidelines provide a framework for nonclinical studies accompanying investigational new drug and biologics license applications, offering recommendations on sequencing strategies and sample analysis.
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Replimune Faces Challenges After Second FDA Rejection of Melanoma Drug

Replimune Faces Challenges After Second FDA Rejection of Melanoma Drug

Replimune Faces Challenges After Second FDA Rejection of Melanoma Drug
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FDA Introduces New Draft Safety Guidelines to Accelerate Bespoke Gene Therapies

FDA Introduces New Draft Safety Guidelines to Accelerate Bespoke Gene Therapies

The FDA has released new draft guidance aimed at standardizing safety evaluations for genome editing therapies. This initiative is part of a broader effort to expedite the development of personalized treatments for ultra-rare diseases. The guidance, issued by the FDA’s Center for Biologics Evaluation and Research, builds on previous guidelines from 2024 and focuses on both ex vivo and in vivo products. It includes recommendations for sequencing strategies and analysis parameters to ensure comprehensive safety assessments. The FDA is seeking public comments on these guidelines, which are designed to support nonclinical studies accompanying investigational new drug and biologics license applications. This move follows the FDA's earlier announcement of a new pathway to accelerate bespoke therapies, exemplified by the creation of a custom CRISPR therapy for a child with a rare metabolic condition.
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Avalyn Pharma Files for IPO to Fund Respiratory Disease Treatments

Avalyn Pharma Files for IPO to Fund Respiratory Disease Treatments

Avalyn Pharma Files for IPO to Fund Respiratory Disease Treatments