Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura. On November 9, 2023, FDA announced the approval of Adzynma, the first genetically engineered protein product for preventative or on-demand enzyme replacement therapy (ERT) for adult and pediatric patients with congenital thrombotic
Aitia will access Charles River’s Logica drug solution platform to develop therapeutic programs for neurodegenerative disease and oncology. Aitia, a drug development and drug discovery technology company, announced on Nov. 13, 2023 a partnership with Charles River Laboratories, a contract development and manufacturing organization. Under the partnership, Aitia will
Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more. The European Medicines Agency (EMA) announced on Nov. 10, 2023 that its Committee for Medicinal Products for Human Use (CHMP) has recommended approval of eight new medicines at its latest meeting. The medicines, three of
Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time. The European Medicines Agency (EMA) announced on Nov. 8, 2023 that the Heads of Medicines Agencies (HMA), the European Commission, and EMA have published electronic product information (ePI)
The document includes recommendations for the reporting and implementation of changes to container closure system components. On Nov. 7, 2023, FDA issued final guidance that includes recommendations for reporting post-approval changes of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile
This is the second biologic approved to treat HS, a painful and reoccurring skin disease. On Oct 31, 2023, Novartis announced FDA’s approval of Cosentyx (secukinumab) as a treatment for adults with moderate to severe hidradenitis suppurativa (HS). As reported by Novartis, Cosentyx is the only FDA-approved fully human
The EC is calling for interested parties for their safety and orphan drug committees. On Nov. 3, 2023, the European Commission announced it was launching a selection procedure for experts looking to join the European Medicines Agency’s (EMA’s) independent Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Orphan
According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines. The US Pharmacopeia (USP) announced on Oct. 30, 2023, that ATCC and USP have collaborated to create a set of joint products to advance quality control of biological therapies and
The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing. TriLink BioTechnologies, a Maravai LifeSciences Company, announced on Nov. 2, 2023 that it has launched the Analytical Sciences Center of Excellence (ASCE). The new ASCE hub expands the company’s suite