Approvals September 4, 2024 UK MHRA grants authorisation for Moderna’s updated Covid-19 vaccine By PBR Staff Writer With the MHRA approval, the updated vaccine will be included in the National Health Service (NHS) autumn vaccination programme. The company noted that the vaccine will be given
ApprovalsInfectious Disease September 2, 2024 Novavax’s updated Covid-19 vaccine receives FDA emergency use authorisation By PBR Staff Writer The Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) [NVX-CoV2705] is now authorised for active immunisation against Covid-19. Following the EUA, the vaccine is also recommended by the US Centers
Drug DiscoveryImmunology August 30, 2024 Johnson & Johnson seeks FDA approval for generalised myasthenia gravis therapy By PBR Staff Writer The application is supported by findings from the Phase III Vivacity-MG3 clinical trial. Assessing the improvement in the MG-ADL score from baseline over 24 weeks was the primary
Drug DiscoveryResearch & DevelopmentOncology August 29, 2024 Bayer partners with NextRNA to develop lncRNA-targeting cancer therapies By PBR Staff Writer lncRNAs are a class of therapeutic targets that play a critical role in disease by recruiting RNA-binding proteins (RBPs). The companies will focus on advancing two oncology programmes
RegulationOncology August 28, 2024 Zuellig Pharma and Regeneron sign deal to supply Libtayo in South Korea and Taiwan By PBR Staff Writer A fully human monoclonal antibody, Libtayo acts on the immune checkpoint receptor PD-1 on T cells. It is said to be the first-line monotherapy approved for advanced non-small
RegulationDrug DiscoveryNeurology August 27, 2024 FDA grants orphan drug status for RedHill’s opaganib for neuroblastoma By PBR Staff Writer This designation is set to provide opaganib with seven years of marketing exclusivity upon approval for this indication. Orphan drug status may also offer additional benefits, including potential
ApprovalsInfectious Disease August 26, 2024 Moderna’s RSV vaccine mRESVIA gains EC approval By PBR Staff Writer This follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid across all 27 EU member states,
RegulationDrug Discovery August 23, 2024 FDA grants orphan drug status to Ractigen’s RAG-18 for DMD and BMD By PBR Staff Writer RAG-18 is claimed to be the first saRNA therapeutic to receive ODD status. DMD and BMD are caused by mutations in the DMD gene. The FDA grants ODD
Production & Sales August 22, 2024 RedHill launches Talicia in UAE to treat H. pylori infection By PBR Staff Writer The launch may lead to additional milestone payments, minimum sales payments, and royalties for RedHill on net sales. Talicia is the only low-dose rifabutin-based therapy which received approval
RegulationOncology August 21, 2024 GSK’s B7-H3-targeted ADC receives FDA breakthrough therapy status By PBR Staff Writer This asset is being assessed to treat patients with relapsed or refractory extensive-stage small-cell lung cancer (ES-SCLC) who have shown disease progression on or following treatment with platinum-based