Research & Development August 29, 2023 Allucent to expedite Covid-19 booster vaccines development By PBR Staff Writer These candidates are being developed to offer better protection, extend the duration in preventing illness and transmission, as compared to the current vaccine technologies. As part of the
Approvals August 28, 2023 Akeso receives priority review of ivonescimab NDA in China By PBR Staff Writer Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody. It is the company’s other new antibody with a priority review following the marketing approval of cadonilimab. After the
Oncology August 25, 2023 Alentis’ ALE.C04 receives fast track designation from FDA By PBR Staff Writer The first-in-class, investigational monoclonal antibody ALE.C04 has been developed for targeting exposed CLDN1 in specific on cancer cells. It is designed to treat cancer by remodelling of the
Prostate Cancer August 24, 2023 FDA grants priority review to Pfizer and Astellas’ sNDA for XTANDI By PBR Staff Writer The regulator has provided a prescription drug user fee act (PDUFA) date of fourth quarter this year for the review. The sNDA is being reviewed under two initiatives
Immunology August 23, 2023 EC grants CMA to Janssen’s Talvey for multiple myeloma By PBR Staff Writer These therapies include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Talvey recently received the US Food and Drug Administration’s approval for the same indication in
Oncology August 22, 2023 CanariaBio receives orphan drug designation for pancreatic cancer therapy By PBR Staff Writer MAb-AR20.5 is an IgG1k type murine monoclonal antibody that attaches specifically to the circulating and tumour-associated antigen (MUC1) expressed on pancreatic cancer cells. It is said to become
Approvals August 21, 2023 FDA accepts sNDA and grants priority review for Calliditas’ TARPEYO capsules By PBR Staff Writer The regulator has provided the Prescription Drug User Fee Act (PDUFA) date of 20 December this year for the review. Currently approved under accelerated approval, TARPEYO is developed
Oncology August 18, 2023 Abcuro raises $155m from Series B to advance autoimmune pipeline By PBR Staff Writer The Series B round was co-led by Redmile Group and Bain Capital Life Sciences. It saw participation of new and existing investors including RA Capital Management, Samsara BioCapital,
Oncology August 17, 2023 Day One, Sprint Bioscience collaborate for VRK1 programme By PBR Staff Writer As per the terms of the deal, Sprint will receive $3m as upfront payment. Day One will also reimburse Sprint for pre-clinical research and development expenses. Additionally, Sprint
In Vitro DiagnosticsApprovals August 16, 2023 FDA accepts Venatorx’s NDA for cefepime-taniborbactam antibiotic By PBR Staff Writer The regulatory agency has granted priority review for this NDA with Prescription Drug User Fee Act (PDUFA) target action date of 22 February next year. It earlier granted