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Advances in Rare Disease Regulatory Policy and FDA Dynamics
Landmark upcoming FDA approval decisions will test the agency's commitment to biomarker-based accelerated approvals for orphan drugs, potentially reshaping rare disease regulatory frameworks....
Multicancer Detection Startup Wholomics Pursues Metabolomic Precision
Wholomics, founded by researchers from Dana Farber and University College London, presented new data demonstrating its serum-based metabolomic platform’s ability to detect multiple cancers at...
New Genetic ‘Dimmer Switch’ Regulates Embryonic Gene Expression
Researchers at the MRC London Institute of Medical Sciences identified a novel DNA attenuator element that precisely modulates the duration and strength of Cdx2 gene expression during early...
Severe Epilepsy Linked to SLC13A5 Citrate Transporter Mutations
A comprehensive functional and structural analysis led by Giulio Superti-Furga at CeMM uncovered how mutations in the citrate transporter SLC13A5 disrupt neuronal metabolism, causing a severe...
Novel Urine-Based DNA Test Enhances Bladder Cancer Immunotherapy
A multi-institutional study published in European Urology demonstrated that quantification of urine tumor DNA (utDNA) can accurately predict recurrence risk in patients with high-risk...
Vetter Launches $285M Clinical Manufacturing Facility in Illinois
German contract development and manufacturing organization Vetter initiated construction of a new 160,000-square-foot clinical production site in Des Plaines, Illinois, with an estimated...
FDA Unwinds Safety Barriers for CAR-T Therapies – Access Boosted
The FDA has removed previous safety monitoring requirements and loosened administration restrictions for approved CAR-T therapies, signaling a significant shift in regulatory policy to improve...
Alphabet’s Calico Locks in $596M Mabwell Deal for Age-Related Drug
Alphabet's Calico Life Sciences inked an exclusive licensing deal with Mabwell Bioscience for up to $596 million targeting interleukin-11 therapeutics. Calico gains global rights, excluding...
Innovative Genomic Platform Boosts Multi-Cancer Early Detection
Wholomics, a startup leveraging metabolic, lipidomic, and lipoproteomic serum signatures via a nuclear magnetic resonance platform, presents promising multi-cancer detection capabilities. Early...
DNA-Based Genetic Dimmer Switch Controls Embryonic Gene Timing
Researchers at the MRC London Institute of Medical Sciences identified a novel cis-regulatory DNA element functioning as an attenuator that precisely modulates the temporal expression of Cdx2, a...
Protein Engineering Breakthrough: Precise Codon Expansion via RNA Editing
Scientists at Peking University devised a novel RNA codon expansion platform that installs programmable pseudouridine modifications into mRNA codons to enable precise incorporation of noncanonical...
Van Andel Discovery Pinpoints PTGIR as Immune Checkpoint in Cancer
A study published in Nature Immunology by Van Andel Institute and collaborators reveals prostacyclin receptor PTGIR as a novel immune checkpoint that regulates CD8+ T cell exhaustion within the...
Major FDA Regulator’s Intervention in KalVista Review Stirs Controversy
Multiple sources report that FDA Commissioner Marty Makary sought to influence the agency’s review process by advocating for rejection of KalVista Pharmaceuticals’ investigational rare disease...
Vetter Breaks Ground on $285M Clinical Manufacturing Hub in Illinois
Contract Development and Manufacturing Organization (CDMO) Vetter commenced construction on a new clinical manufacturing site in Des Plaines, Illinois, with an investment of approximately $285...
New Organ Chip Model Predicts Chemotherapy Outcomes in Esophageal Cancer
A novel precision oncology platform has been developed to forecast chemotherapy responses in esophageal adenocarcinoma (EAC) patients, addressing the high rate of chemoresistance in this lethal...
Qiagen Expands Clinical Digital PCR Menu via Partnership Program
Qiagen has launched an open partnership initiative to broaden its in vitro diagnostic assay offerings for the QiAcuityDx clinical digital PCR system. The program invites diagnostic developers and...
FDA Drops Safety Monitoring for CAR-T Therapies to Expand Patient Access
The U.S. Food and Drug Administration (FDA) has eliminated the Risk Evaluation and Mitigation Strategies (REMS) safety monitoring requirements for all approved CAR-T cell therapies. This...
Alphabet’s Calico Signs $596M Deal for Mabwell’s IL-11 Therapeutic Program
Calico Life Sciences, backed by Alphabet, has secured exclusive global rights (outside China) to Mabwell Bioscience’s IL-11 targeting monoclonal antibody 9MW3811 in a deal worth up to $596 million...
St. Jude's ColdBrew Algorithm Illuminates Water's Role in Drug Design
Researchers at St. Jude Children’s Research Hospital have developed ColdBrew, a novel computational algorithm that more accurately models the presence and behavior of water molecules within...
New Genetic Dimmer Switch Discovered Regulating Embryonic Development Gene Cdx2
Scientists at the MRC London Institute of Medical Sciences have identified a novel DNA element functioning as a temporal 'dimmer switch' that precisely attenuates expression of the critical...