TEVA PHARMACEUTICALS USA, INC.
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News
Teva's Emrusolmin Receives FDA Fast Track Designation for Multiple System Atrophy Treatment
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 Launches First Generic GLP-1 Weight Loss Drug as FDA Approves Generic Saxenda
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 Secures Patent Protection for FIRDAPSE Until 2035 Through Lupin Settlement
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 Appeals to FDA Commissioner Makary Over Generic Hetlioz Approvals Following Court Victory
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 Launches Celea Therapeutics to Advance Phase 3-Ready IPF Treatment
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.
FDA Approves First CGRP Antagonist for Pediatric Migraine Prevention as Ajovy Expands to Children
The FDA has approved Ajovy (fremanezumab-vfrm) for preventive treatment of episodic migraine in children and adolescents aged 6-17 years weighing at least 45 kg, making it the first CGRP antagonist approved for pediatric migraine prevention.
Alvotech Appoints Linda Jónsdóttir as Chief Financial Officer
Alvotech, a global biosimilar medicines company, has appointed Linda Jónsdóttir as Chief Financial Officer, bringing 15 years of senior leadership experience from Marel food processing technology company.
Alvotech Acquires Swiss Packaging Specialist Ivers-Lee to Expand Biosimilar Manufacturing Capacity
Alvotech has acquired Ivers-Lee Group, a Swiss family-owned pharmaceutical packaging company founded in 1947, to expand its assembly and packaging capabilities ahead of three new biosimilar launches in 2025.
Five-Year SEQUOIA Data Confirms Zanubrutinib's Long-Term Efficacy in High-Risk CLL/SLL Patients
Five-year follow-up data from the SEQUOIA study demonstrates zanubrutinib's sustained efficacy in treatment-naive chronic lymphocytic leukemia and small lymphocytic lymphoma patients with del(17p).
Alvotech Expands European Presence with Successful Nasdaq Stockholm Listing
Alvotech's Swedish Depository Receipts (SDRs) offering was multiple times oversubscribed, attracting over 3,000 new shareholders and raising approximately SEK 39 million.