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Prime Editing Reverses Rare Childhood Brain Disorder in Mice
Researchers at the Broad Institute and Jackson Laboratory have demonstrated successful use of prime editing to correct five distinct genetic mutations causing alternating hemiplegia of childhood...
Alkermes Advances Narcolepsy Drug with Midstage Trial Win
Alkermes reported positive Phase 2 results for alixorexton, a novel orexin agonist for narcolepsy type 1, showing statistically significant improvements in wakefulness and reductions in excessive...
FDA Names George Tidmarsh as CDER Director
The FDA announced the appointment of George Tidmarsh, a veteran biotech executive and oncologist, as director of the Center for Drug Evaluation and Research (CDER). Tidmarsh’s extensive background...
Roche’s Columvi Rejected by FDA for Earlier Lymphoma Treatment
Roche and subsidiary Genentech received a complete response letter from the FDA declining approval to expand Columvi’s indication to earlier treatment for diffuse large B-cell lymphoma (DLBCL)...
Omega Funds Raises $647 Million for Life Sciences Investment
Omega Funds closed its eighth venture fund at $647 million, matching its previous 2021 fund size and surpassing its $600 million target. The Boston and Geneva-based life sciences investor plans to...
DeNovix Launches Advanced Fluorescence Cell Counting Apps
DeNovix introduced new applications for its CellDrop FLxi cell counter, expanding capabilities in stem cell viability, apoptosis analysis, and yeast vitality assessment. The Stem Cell app utilizes...
Virginia Biotech Sector Expands with BIO Visit Spotlight
Virginia’s bioscience industry continues robust growth, supported by over $1 billion in R&D and 415 new patents in 2023. The Biotechnology Innovation Organization (BIO) captured this momentum...
Gene Therapy for Osteoarthritis Receives FDA Regenerative Medicine Designation
Genascence’s GNSC-001, a gene therapy delivering an interleukin-1 receptor antagonist for knee osteoarthritis, secured FDA Regenerative Medicine Advanced Therapy (RMAT) designation. Administered...
Emerging Biotech Partnerships in Asia Target Age-Related and Biosimilar Markets
Chugai Pharmaceutical formed an agreement with Singapore-based Gero to co-develop therapies targeting age-related diseases using Gero’s AI-powered target discovery platform and Chugai’s antibody...
Alkermes advances narcolepsy candidate with midstage win
Alkermes has reported positive Phase 2 results for its narcolepsy type 1 drug candidate alixorexton, demonstrating statistically significant improvements in wakefulness and reductions in daytime...
FDA appoints biotech veteran Tidmarsh to lead drug evaluation
The FDA has named George Tidmarsh, a seasoned biotech executive and physician-scientist with a background in oncology and pediatrics, as Director of the Center for Drug Evaluation and Research...
Roche and peers face setbacks with biologics in COPD treatment
Roche disclosed disappointing Phase 3 data for astegolimab, an anti-ST2 monoclonal antibody targeting chronic obstructive pulmonary disease (COPD). The biologic failed to reduce disease flare-ups,...
Omega Funds closes $647 million life sciences fund amid funding doldrums
Boston and Geneva-based life sciences investor Omega Funds announced the final close of its eighth fund at $647 million, matching the size of its 2021 vehicle. Despite a biotech venture capital...
Sarepta shares plunge after third gene therapy patient death
Sarepta Therapeutics’ stock dropped 36% following news of a third patient death linked to its gene therapy programs. The most recent fatality occurred in a 51-year-old participant in the Phase I...
AI and antibody engineering unite in Chugai-Gero aging therapies deal
Chugai Pharmaceutical of Japan has signed a research and licensing agreement with AI-focused biotech Gero PTE of Singapore to develop therapies targeting age-related diseases. The partnership...
FDA grants RMAT to Genascence’s gene therapy for osteoarthritis
Genascence's GNSC-001 gene therapy received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The therapy uses a recombinant adeno-associated viral vector to deliver an...
Oxford Nanopore reports 25% revenue surge, fueled by applied markets
Oxford Nanopore Technologies posted preliminary H1 2025 revenues of approximately £105 million, up 25% from the same period last year and exceeding company expectations. Growth was driven by both...
Novel polygenic risk score predicts adult obesity in early childhood
An international research consortium developed a polygenic risk score (PGS) based on genetic data from over five million people capable of predicting a child's likelihood of developing adult...
Emerging manufacturing advances for scaling AAV gene therapies
The field of adeno-associated virus (AAV)-based gene therapy is rapidly expanding beyond rare diseases to address more prevalent conditions such as cardiovascular and neurological disorders. This...
Alkermes’ Narcolepsy Drug Moves Forward with Mid-Stage Success
Alkermes announced that its oral drug alixorexton significantly improved wakefulness and reduced daytime sleepiness in patients with narcolepsy type 1 during a Phase 2 clinical trial. While only...