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Alpha Tau Medical’s localized alpha radiation therapy triggers systemic anti-cancer immunity
Alpha Tau Medical’s Alpha DaRT treatment employs localized alpha radiation delivered directly into tumors, demonstrating 100% tumor response in early FDA trials across multiple solid tumor types,...
FDA Rejects Ultragenyx Gene Therapy Over Manufacturing Issues
Ultragenyx Pharmaceutical received a complete response letter from the FDA declining approval of its gene therapy UX111 for Sanfilippo syndrome type A, citing manufacturing-related concerns during...
AstraZeneca Advances Hypertension Drug with $1.3B CinCor Deal Paying Off
AstraZeneca’s experimental aldosterone synthase inhibitor baxdrostat demonstrated statistically significant reductions in systolic blood pressure in a phase III trial involving patients with...
Takeda Narcolepsy Drug Oveporexton Scores Double Phase 3 Wins
Takeda’s oral orexin receptor 2-selective agonist oveporexton met all primary and secondary endpoints in two phase III studies for narcolepsy type 1, demonstrating clinically meaningful...
Waters and BD Merge in $17.5B Life Sciences Deal
Waters Corp. has agreed to combine with Becton, Dickinson & Co.'s Biosciences & Diagnostics Solutions business in a transaction valued at $17.5 billion, marking the largest life sciences deal of...
Integrated Optogenetics Platform Uncovers New Antiviral Compounds
Integrated Biosciences has developed a novel optogenetic screening platform enabling precise control and high-throughput interrogation of biological systems, facilitating discovery of selective...
Alzheimer’s Biomarkers via Circular RNA and Proteomics in Depression Patients
Researchers at Washington University and Circular Genomics have identified circular RNA (circRNA) biomarkers, including circHOMER1, associated with Alzheimer’s disease diagnosis and progression....
Innovations in Personalized Cancer Therapeutics Manufacturing
Elegen and Nutcracker Therapeutics have partnered to pilot a fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapies. The combined approach addresses...
Mink Therapeutics’ Agent-797 Drives Durable Cancer Remission
Mink Therapeutics reported a remarkable clinical response wherein a testicular cancer patient achieved complete remission following administration of their off-the-shelf invariant natural killer...
CRISPR Guide RNA Efficiency Varies with Ancestry, Risks Off-target Effects
A study led by the Broad Institute and Dana-Farber Cancer Institute revealed that CRISPR-Cas9 gene editing guide RNAs have varied efficiency depending on the ancestry of the cancer cell lines,...
Ultragenyx Gene Therapy Faces FDA Hurdles: Manufacturing Issues Trigger CRL
Ultragenyx Pharmaceutical has encountered a regulatory setback as the FDA issued a complete response letter (CRL) for its gene therapy UX111 aimed at treating Sanfilippo syndrome type A, a rare...
AstraZeneca’s Baxdrostat Validates $1.8B CinCor Bet With Phase III Win
AstraZeneca reported positive Phase III results for baxdrostat, an aldosterone synthase inhibitor targeting uncontrolled and treatment-resistant hypertension. The trial met all primary and...
Takeda Advances Narcolepsy Treatment With Dual Phase III Trial Success
Takeda Pharmaceutical announced positive outcomes from two Phase III clinical trials for oveporexton, an oral orexin receptor 2-selective agonist in narcolepsy type 1. The studies met all primary...
Waters Corp to Acquire BD’s Biosciences & Diagnostics in $17.5 Billion Deal
Waters Corporation announced plans to merge with the Biosciences and Diagnostic Solutions unit of Becton, Dickinson & Co. in a transaction valued at $17.5 billion, marking the largest life...
Innovative RNA Manufacturing Partnership Targets Personalized Cancer Therapeutics
Elegen and Nutcracker Therapeutics launched a pilot program integrating their platforms to enable industry-first fully synthetic, cell-free manufacturing of RNA-based personalized cancer...
FDA Launches Transparency Initiative by Publishing Drug Rejection Letters
In a move toward regulatory openness, the FDA released over 200 complete response letters (CRLs) corresponding to drug application denials, marking a step in the agency's modernization and...
AI-powered Optogenetic Screening Platform Accelerates Drug Discovery
Integrated Biosciences unveiled a novel optogenetic screening platform combining programmable light-activation with high-throughput compound testing, enabling precise interrogation of biological...
China Biotech Licensing Gains Traction in US Market Amid Pricing Pressures
A Jefferies report highlights significant growth in licensing deals from Chinese biotech companies to multinational pharmaceutical firms, with China now accounting for 32% of outlicensing deal...
New Biomarkers and Mechanisms in Neurodegenerative Disease Research
Recent studies uncover advancements in Alzheimer's and Parkinson's disease diagnostics and biology. Circular Genomics and Washington University developed a circular RNA biomarker signature,...
Industry Consolidation and Financing Activity in Biotech and Med-Tech
The biotech and med-tech sectors report significant financial and managerial movements. PCI Pharma Services secured private equity funding valuing the CDMO at $10 billion, backed by Bain Capital,...