GSK has won FDA approval for a single-vial formulation of its meningococcal disease vaccine Menveo, thereby ending the need for reconstitution that has existed since the product came to market in 2010.
Romaco Holding GmbH has appointed Sanjeev A Nimkar as new managing director of Romaco India Pvt. Ltd. From mid-October 2022, he will be responsible in this role for managing all operations of Romaco’s Indian sales & service centre, with headquarters in Mumbai and a branch office in Hyderabad.
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option. The Menveo one-vial presentation will initially be available to US federal customers, with broader availability anticipated in mid-2023.
In one of the first big tests for Pfizer's new vaccine R&D chief Annaliesa Anderson, Ph.D, the company appears to have passed a phase 3 study of its five-in-one meningococcal shot with flying colors.
The European Medicines Agency announced on Sept. 18, 2020 that its human medicines committee (CHMP) has recommended approval for Exparel (bupivacaine), for the treatment of post-operative pain; MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y; and Supemtek (Quadrivalent Influenza Vaccine). Market authorization under exceptional circumstances was recommended for the anthrax treatment, Obiltoxaximab SFL (obiltoxaximab). CHMP also gave a positive opinion to the biosimilar Nyvepria (pegfilgrastim) “for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy.”