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The latest move follows the receipt of marketing authorisation for PRX-102 from the European Commission (EC) for the same indication. The PEGylated enzyme replacement therapy (ERT), PRX-102 is

Through the collaboration, Sandoz will gain access to Just – Evotec Biologics’ AI-driven, fully integrated technology platform, which provides development and continuous manufacturing of fully integrated drug substance.

This partnership aims to help advance the company’s partial epigenetic reprogramming platform for aging-related diseases, such as its lead programme that targets the ophthalmic indications. Through the alliance,

The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with

Under the collaboration, Neogap will provide its EpiTCer technology for Cellerys’ upcoming Phase II study of an innovative cell therapy to fight multiple sclerosis. The RED4MS therapy is

The launch involves the firm’s XATEPA product, a pain-relieving pharmaceutical drug developed using cannabinoids. The company aims to boost the sales of XATEPA as well as launch the

This therapy is being developed to treat Myosin Binding Protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). TN-201 is the firm’s potential first-in-class adeno-associated virus (AAV)-based investigational gene therapy to

The regulator, in its complete response letter (CRL), mentioned concerns regarding the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product. It

The next generation topical phosphodiesterase-4 (PDE4) inhibitor Zoryve is also indicated to treat psoriasis in the intertriginous areas. It uses a drug delivery formulation, HydroARQ Technology, which creates