Central Nervous System March 6, 2023 Ractigen receives orphan drug designation for ALS therapy By PBR Staff Writer RAG-17 has been designed to act on and knockdown SOD1 expression in patients with pathogenic mutations that are known to cause ALS. The chemistry of the therapeutic is
Neurology March 3, 2023 Avenue signs license agreement with AnnJi Pharmaceutical for AJ201 By PBR Staff Writer Designed to modify SBMA through several mechanisms, AJ201 is currently in a Phase Ib/IIa study in the US to treat spinal and bulbar muscular atrophy (SBMA), which is
Other Diseases March 2, 2023 Nexus Pharmaceuticals gets FDA approval for Emerphed pre-filled syringe By PBR Staff Writer The company claimed that its 10mL presentation is the only FDA-approved ready-to-administer 10mL pre-filled syringe available. Nexus Pharmaceuticals CEO and president Usman Ahmed said: “We are pleased to
Drug DiscoveryResearch & Development March 1, 2023 Tempus, Pfizer partner for cancer drug development By PBR Staff Writer Under the collaboration, both the companies will work together for further AI and machine learning-driven efforts in therapeutic development. The partnership aims to gather insights more precisely that
RegulationApprovals February 28, 2023 AbbVie gets positive CHMP opinion for upadacitinib to treat Crohn’s disease in adults By PBR Staff Writer Upadacitinib (RINVOQ, 45mg [induction dose] and 15mg and 30mg [maintenance doses]) is intended for those patients who have not shown adequate response, lost response or were intolerant to
Skin RashDrug Manufacturing February 27, 2023 Timber’s TMB-001 receives orphan drug designation from EC to treat XLRI By PBR Staff Writer Earlier, TMB-001 received orphan drug designation from the EC to treat autosomal recessive congenital ichthyosis (ARCI). Timber Pharmaceuticals chairman and CEO John Koconis said: “We are pleased to
Oncology February 24, 2023 Xspray Pharma and Eversana sign agreement for US launch of cancer therapy By vbandhakavi Xspray Pharma will maintain financial and strategic control and grant exclusive commercialisation access to Eversana for supporting its Dasynoc launch. Dasynoc, pending approval from the Food and Drug
RegulationApprovals February 23, 2023 EMA grants ODD to Sage Therapeutics’ SAGE-718 to treat Huntington’s disease By PBR Staff Writer SAGE-718 is a first-in-class NMDA receptor positive allosteric modulator (PAM) as well as lead neuropsychiatric drug candidate. It is in development as a potential oral therapy for cognitive
Drug Manufacturing February 22, 2023 Icosavax receives fast track designation for IVX-A12 vaccine candidate By vbandhakavi Said to be the company’s first combination vaccine candidate, IVX-A12 targets RSV as well as hMPV, which are two of the top five causes of pneumonia in adult
Infectious DiseaseDrug Filing February 21, 2023 FDA accepts Valneva’s chikungunya vaccine BLA for priority review By PBR Staff Writer The regulatory agency has ascertained that the application is sufficiently finished to allow a substantive review. Valneva, a specialty vaccine company, stated that the review is classified as