TEVA PHARMACEUTICALS USA, INC.

The FDA issued a complete response letter for Alvotech's AVT05, a biosimilar candidate to Simponi (golimumab), citing manufacturing facility deficiencies that must be resolved before approval.

Alvotech announced significant leadership changes with Chief Commercial Officer Anil Okay stepping down to become CEO of Adalvo, marking a strategic transition in the company's commercial operations.

Teva Pharmaceuticals has entered into a license and supply agreement with Prestige Biopharma to commercialize Tuznue, a biosimilar to Herceptin (trastuzumab), across a majority of European markets.

The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval for Gobivaz, Alvotech's proposed biosimilar to Simponi.

Teva's Phase 3 SOLARIS trial demonstrated no post-injection delirium/sedation syndrome (PDSS) events with olanzapine LAI (TEV-'749) through 56 weeks across 3,470 total injections.

Teva Pharmaceuticals received FDA Fast Track designation for emrusolmin (TEV-56286), an investigational small molecule therapy targeting alpha-synuclein protein for Multiple System Atrophy treatment.

Teva Pharmaceuticals received FDA approval and launched the first-ever generic GLP-1 receptor agonist indicated for weight loss in the United States.

Catalyst Pharmaceuticals and SERB S.A. reached a settlement agreement with Lupin that prevents generic competition for FIRDAPSE (amifampridine) until February 25, 2035.

Vanda Pharmaceuticals has requested FDA Commissioner Martin Makary to review the agency's approval of two generic versions of Hetlioz, challenging what it calls an "unacceptable culture of bias" toward generic drugs.

PureTech Health has launched Celea Therapeutics as a new subsidiary focused on respiratory diseases, with deupirfenidone (LYT-100) as its lead Phase 3-ready candidate for idiopathic pulmonary fibrosis.