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Alkermes Narcolepsy Drug Advances with Positive Phase 2 Results
Alkermes reported positive mid-stage clinical trial results for its oral orexin receptor agonist, alixorexton, in narcolepsy type 1 patients. The drug improved wakefulness across all doses and...
Roche’s COPD Biologic Faces Setbacks in Phase 3 Trials
Roche’s investigational IL-33-targeting antibody, astegolimab, failed to meet primary endpoints in a pivotal Phase 3 COPD trial, mirroring similar failures by Regeneron and Sanofi's biologics in...
Prime Editing Reverses Childhood Brain Disorder in Mice
Researchers at the Broad Institute and Jackson Laboratory successfully applied prime editing to correct five genetic mutations causing alternating hemiplegia of childhood (AHC) in mice. Treated...
Biotech Investment Remains Robust Amid Funding Challenges
Omega Funds closed its eighth life sciences investment fund at $647 million, sustaining its commitment to backing innovative biotech companies despite broader declines in venture capital funding....
Sanner Launches U.S. Production Facility to Boost Pharma Packaging
Sanner inaugurated its first U.S.-based manufacturing site in Greensboro, North Carolina, featuring advanced GMP-certified cleanrooms and high-speed production capabilities. This move enhances...
UCLA and Dongwoon Anatech Collaborate on Saliva-Based Cancer Diagnostics
UCLA's School of Dentistry and South Korean firm Dongwoon Anatech have forged a $2.4 million collaboration to develop saliva-based liquid biopsy technologies. The partnership aims to create a...
New Sensor Detects Plant Stress for Agriculture Advancement
Researchers developed a minimally invasive sensor capable of measuring hormone levels in plants in real-time with precision and minimal damage. This technology aims to deepen understanding of...
Sarepta Faces FDA Scrutiny After Gene Therapy Patient Deaths
Sarepta Therapeutics is under intensified regulatory scrutiny following the deaths of three patients linked to its gene therapies. The most recent fatality involved a 51-year-old man with limb...
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,...