New data from the QWINT clinical trial may get Eli Lilly closer to bringing a once-weekly insulin injection to the US, following the FDA’s rejection of Novo Nordisk’s own weekly insulin formulation earlier this year.
Rare disease biotech Rezolute recently announced that the FDA has lifted the partial clinical hold on RZ358 (ersodetug), a novel therapy in development for the treatment of low blood sugar (hypoglycemia) resulting from congenital hyperinsulinism.
Forge Biologics will help with the manufacturing of adeno-associated viruses (AAVs) in a collaboration with the non-profit Muscular Dystrophy Association (MDA) to develop gene therapies for neuromuscular diseases.
Adaptin Bio has announced that the FDA has given the green light to start phase 1 clinical trials for its program APTN-101 targeting glioblastoma, the most common and aggressive form of brain cancer.
The San Diego-based biotech company Candid Therapeutics has launched with a huge $370 million with the aim to develop T-cell engager therapies for autoimmune diseases.
Creyon Bio Inc., a clinical-stage biotechnology company specializing in AI and machine learning-enabled oligonucleotide-based medicines (OBMs), recently announced the issuance of its second US patent.
The European Commission has granted Orphan Drug Designation for Vivet Therapeutics’ gene therapy product VTX-806 for the treatment of Cerebrotendinous Xanthomatosis (CTX).
In one of the largest cell and gene therapy funding rounds this year, the US company Arsenal Biosciences has secured $325 million in a Series C round to bankroll T cell therapies engineered to take on solid tumors.
The U.S. company Emergent BioSolutions recently announced the FDA approval of its application to expand the indication for ACAM2000 – previously approved for smallpox – to include the prevention of mpox in high-risk individuals.
As Orgenesis works to decentralize and democratize CAR-T therapies, its candidate therapy has shown complete response rates of more than 80% in a clinical study in China.
