Five months after getting a complete response letter from the U.S. FDA, Regeneron Pharmaceuticals Inc. has landed conditional European marketing approval for odronextamab, a bispecific antibody for treating lymphoma. Now named Ordspono, the approval is for treating adult patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, after two or more lines of therapy. The European Commission also approved Merck & Co. Inc.’s Winrevair (sotatercept) for pulmonary arterial hypertension and ARS Pharmaceuticals Inc.'s Eurneffy (inhaled epinephrine) for anaphylaxis.
The BioWorld Infectious Disease Index (BIDI) has rebounded significantly from its lowest point this year, improving from a 25.12% drop in late April to a 7.66% decline by the end of July. Despite the recovery, BIDI still lagged behind the Nasdaq Biotechnology Index, which rose 10.82% by July’s close, and the Dow Jones Industrial Average, which gained 8.25% year to date.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abata, Bioarctic, Eisai, Innovent, Merck, Ractigen.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cyclo, Liquidia, Oblique, Pharmadrug, Pharmather, Rafael Holdings, Sairiyo, United.
Researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne have discovered new cells that drive the aging process in the thymus that could unlock a way to restore function and prevent immunity from waning as we age. The thymus is the first organ in the body to shrink as people age. As this happens, the T-cell growth areas in the thymus are replaced with fatty tissue, diminishing T-cell production and contributing to a weakened immune system.