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Alvotech resubmits FDA applications for Simponi and Eylea biosimilars

Alvotech (NASDAQ:ALVO) has officially resubmitted its Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for two of its lead biosimilar candidates: AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab), and AVT06, a proposed biosimilar to Eylea (aflibercept) 2 mg.

Leia mais: Alvotech resubmits FDA applications for Simponi and Eylea biosimilars
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Biogen and UCB present positive Phase 3 PHOENYCS GO data for lupus candidate dapirolizumab pegol

Biogen (NASDAQ:BIIB) and UCB have announced the release of positive results from the Phase 3 PHOENYCS GO clinical trial evaluating dapirolizumab pegol (DZP), an investigational treatment for systemic lupus erythematosus (SLE).

Leia mais: Biogen and UCB present positive Phase 3 PHOENYCS GO data for lupus candidate dapirolizumab pegol
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Technology

GitLab reduces workforce by 14% as It pivots infrastructure toward AI-agent scaling

GitLab (NASDAQ:GTLB) has confirmed the layoff of approximately 350 employees, representing 14% of its workforce, as the company implements a restructuring plan designed to align its operations with the evolving demands of artificial intelligence.

Leia mais: GitLab reduces workforce by 14% as It pivots infrastructure toward AI-agent scaling
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Kura Oncology positions Darlifarnib as foundational combination platform following strong Phase 1a results

Kura Oncology (NASDAQ:KURA) has released preliminary Phase 1a data showcasing the potential of its next-generation farnesyl transferase inhibitor (FTI), darlifarnib, as a foundational component of combination therapies for KRAS-mutant cancers.

Leia mais: Kura Oncology positions Darlifarnib as foundational combination platform following strong Phase 1a results