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The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.



FDA Issues Guidance on Development of Drugs for Monkeypox

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.

AMB-05X Receives EMA PRIME Designation for Treatment of Tenosynovial Giant Cell Tumor

The partnership led to Asimov licensing its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients. 

Asimov and Center for Breakthrough Medicines Collaborate for Viral Vector Production

The merged company will operate under the name Ayala Pharmaceuticals and will target the development and commercialization of Ayala’s lead program, AL102, for the treatment of desmoid tumors. 

Advaxis, Ayala Pharmaceuticals Complete Merger

Recently, 2seventy bio announced the initiation of a strategic partnership with JW Therapeutics aiming at the collaboration being the development of 2seventy bio’s MAGE-A4 cell therapy in mainland China, Hong Kong, and Macao.

Medigene Receives Historic $3 Million Payment from 2seventy Bio

Snapdragon Chemistry concentrates in API batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges.

Cambrex Acquires Snapdragon Chemistry

Agilent’s $725 million investment is designed to double its capacity to produce APIs.

Agilent Invests $725 Million in Nucleic Acid-based Therapeutics

The BioProfile FAST CDV is a fully automated viable cell density and viability analyzer.

Nova Biomedical Launches Cell Density and Viability Analyzer

Vetter significantly increases its sustainability ranking by achieving gold status in EcoVadis ranking. 

Vetter Wins Gold in EcoVadis Ranking

Pfizer and Gero have partnered to discover potential therapeutic targets for fibrotic diseases using machine learning technology.

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