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
Other Diseases August 15, 2023 Eli Lilly and Company completes acquisition of Versanis Bio By PBR Staff Writer Lilly signed the definitive agreement to acquire Versanis Bio in July this year. At the time of the deal announcement, its terms specified that shareholders of Versanis were
Infectious Disease August 14, 2023 Novartis acquires Chinook Therapeutics for $3.5bn upfront By PBR Staff Writer Stockholders of Chinook will receive $40.00 in cash per share, a total of $3.2bn, from Novartis. Upon achieving certain regulatory milestones, they will further receive $4.00 in cash
Oncology August 11, 2023 Genprex receives FDA orphan drug designation for lung cancer therapy By PBR Staff Writer In June this year, the therapy, in combination with Genentech’s Tecentriq received FDA fast track designation (FTD) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) patients.