A real-world study found evolocumab cut fatal or nonfatal heart attack risk 20% vs ezetimibe in adults with ASCVD and prior statin use.
|Articles|March 15, 2002
- BioPharm International-03-15-2002
- Volume 15
- Issue 3
A System Developer's Approach to Validation
Author(s)Christopher L. Gent
by Christopher L. Gent Pharmacia Corporation Validation is required for computer systems used to create, modify, maintain, archive, retrieve, or transmit data intended for submission. To ensure that the QA/QC and the IT departments speak the same language, a system developer will build documented evidence that a system's functionality has been tested, performs as specified, and generates reproducible results.
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FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.
Johnson & Johnson's amivantamab (Rybrevant Faspro) won accelerated FDA approval for pretreated recurrent head and neck cancer.
Oxford spinout Alethio Therapeutics closed a $90 million Series A to take ATX-011, a monoclonal antibody against the G6B receptor, into Phase 1/2a studies in essential thrombocythemia. It is also developing a G6B-targeted ADC for myelofibrosis.
T-Therapeutics closed an oversubscribed $133 million Series B backed by Eli Lilly, JJDC, and others. The funding will take its first T-cell receptor bispecifics in cancer and autoimmune disease into clinical trials.
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.
FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
Healthy-volunteer data show sustained TL1A suppression and a profile supporting infrequent subcutaneous dosing. Caldera also licensed a second bispecific, targeting IL-17 and TL1A, from Qyuns Therapeutics.
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