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Pfizer Completes Acquisition of Seagen
Further establishes Pfizer as a leading oncology company poised to accelerate the next generation of breakthrough treatments for people with cancer
Kyverna gets FDA fast track status for myasthenia gravis treatment
The latest designation comes after Investigational New Drug (IND) clearance for KYV-101 for use in Kyverna’s KYSA-6 Phase 2 open-label, multicentre trial
Veranex Acquires Leading Preclinical Services Provider T3 Labs
The state-of-the-art preclinical laboratory solidifies Veranex’s commitment to expanding its existing preclinical footprint and deepening its therapeutic expertise
Pfizer obtains all regulatory approvals to close $43bn Seagen acquisition
Pfizer also announced changes in its commercial organisation to incorporate Seagen by creating a new end-to-end business arm called the Pfizer Oncology Division
Japan’s Ministry of Health, Labour and Welfare accepts Arexvy (RSV vaccine) regulatory application to prevent RSV disease in adults aged 50-59 at increased risk
Submission supported by positive results of a Phase III study showing immune response and safety in adults aged 50-59
US FTC seeks to prevent Sanofi’s acquisition of Maze’s pompe disease therapy MZE001
The Commission claimed that the deal, which could be worth up to $755m, would destroy a startup rival ready to challenge Sanofi’s monopoly in the rare disease therapy market
ConcertAI acquires oncology data platform CancerLinQ
The new partnership aims to bolster and broaden CancerLinQ’s use of real-world data, analytics, AI, and other technologies, enhancing cancer care and expediting clinical research
FDA and EMA Accept Marstacimab Regulatory Submissions for the Treatment of Hemophilia A and B
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
Vertex, CRISPR secure FDA approval for gene therapies to treat sickle cell disease
Casgevy is a genome-edited cellular therapy that consists of autologous CD34+ HSCs edited by CRISPR/Cas9 technology, while Lyfgenia is a cell-based gene therapy that uses lentiviral vector for genetic modification
Pfizer’s Elrexfio gets EC nod for relapsed and refractory multiple myeloma
The EC approval was based on findings from cohort A of the Phase 2 MagnetisMM-3 study in which it showed meaningful responses among heavily pre-treated RRMM patients