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The move leverages CTTQ’s extensive reach and portfolio in liver disease, covering more than 5,000 medical centres in China.
Under this agreement, the company will manage the importation, distribution, and hospital access, as well as all promotional and non-promotional activities for bepirovirsen across mainland China.
GSK will retain its role as marketing autho...
The approval process was accelerated after Partner Therapeutics received the FDA Commissioner’s National Priority Voucher.
Bizengri has already received breakthrough therapy and orphan drug designations for this indication.
The US biotechnology company highlighted the clinical need in this patient population, with the new approval marking a regulatory milestone....
The upgrade focuses on providing a unified and accessible framework, eliminating redundant review steps and supporting drug discovery and development projects.
With this updated licensing policy, customers have authorisation to use HEK293 functional cell lines for assay development, drug discovery, internal research, lot release analysis, and quality assurance testing....
The approval is intended for adults with PsA who have had inadequate response or intolerance to previous disease-modifying antirheumatic drug (DMARD) therapy. Sotyktu can be used alone or with methotrexate.
This marks the first approval in the European Union for a tyrosine kinase 2 (TYK2) inhibitor in this indication.
The decision was based on results from the P...
The location will serve as Novartis’ first RLT manufacturing site in Texas and is the company’s fifth such site in the country, increasing supply chain reach for the southern US.
The site is expected to be operational in 2028, adding new roles in quality, operations, bioengineering, and advanced manufacturing. The development supports economic activity in Denton and ne...