The FDA approved the first generic referencing Victoza (liraglutide injection), a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.
With advantages such as utilising bio-compatible materials, the biomolecule-based drug delivery system enables potentially safer drug development, according to the researchers. Nanoparticle drug delivery Researchers in Australia have created an innovative drug delivery system that utilises a metal–biomolecule network (MBN) comprising of non-toxic metal ions together with phosphonate biomolecules, eg, DNA. As the MBN nanoparticles …
Nanoparticle drug delivery innovation could enhance drug development Read More »
New topline Phase I/II data show that an allogeneic cell therapy could help restore vision in individuals with corneal oedema secondary to corneal endothelial dysfunction. AURN001 combines allogeneic human corneal endothelial cells (neltependocel) and a rho kinase inhibitor (Y-27632). The CLARA Phase I/II clinical trial evaluated the safety, tolerability, and efficacy the allogeneic cell therapy product candidate at sites in …
Early allogeneic cell therapy trial results offer hope for sight condition Read More »
The PyroGlutamate-amyloid-beta (PyroGlu-Aβ) programme includes novel antibodies (BAN1503 and BAN2803). These target a truncated, pyroglutamate modified form of amyloid-beta. BAN2803 utilises a technology platform that optimises biologic drug delivery past the blood brain barrier, BioArctic noted. Under the agreement, BioArctic will receive a $100 million, up to $1.25 billion in milestone payments as well as …
Bristol Myers Squibb licenses amyloid-beta antibody programme Read More »
We are getting closer to the end of another year – usually this time gets very busy for everyone, as we still have goals, deadlines, and ambitious plans for what we want to achieve before we take a well-deserved rest. Despite the end-of-year pressure, I do try to stop for a moment, reflect and take …
Emer Cooke, EMA’s Executive Director: 2024 achievements in medicine regulation Read More »
The U.S. Food and Drug Administration issued a final rule establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU).
The U.S. Food and Drug Administration has approved Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors.
FDA approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity.
On December 18, 2024, the Food and Drug Administration approved remestemcel-L-rknd (Ryoncil, Mesoblast, Inc.), an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients 2 months of age and older. Ryoncil is the first FDA-approved MSC therapy.
