RegulationApprovals March 17, 2020 Lilly, Incyte get FDA breakthrough therapy status for baricitinib to treat alopecia areata By PBR Staff Writer AA is an autoimmune disorder, which may result in an unpredictable hair loss on the scalp, face and other areas of the body. The FDA has provided the
Clinical TrialsHuman Trials March 16, 2020 Pfizer, EMD Serono to scrap phase 3 study of avelumab in LA SCCHN By PBR Staff Writer The later stage trial has been evaluating avelumab plus chemoradiotherapy (CRT) in comparison to standard-of-care CRT in patients having untreated locally advanced squamous cell carcinoma of the head
Drug DiscoveryResearch & Development March 12, 2020 Forty Seven, Rocket collaborate on new treatment for Fanconi Anemia By PBR Staff Writer Forty Seven and Rocket Pharmaceuticals have entered into a research collaboration for evaluating a new treatment regimen in Fanconi Anemia, a rare paediatric disease. Fanconi Anemia affects the
RegulationApprovals March 12, 2020 Bristol Myers Squibb gets FDA nod for Opdivo + Yervoy to treat liver cancer By PBR Staff Writer The FDA accelerated approval was based on Opdivo + Yervoy’s overall response rate and duration of response in the cohort of the phase 1/2 CheckMate -040 trial. Around
RegulationApprovals March 11, 2020 Janssen gets FDA breakthrough therapy status for JNJ-6372 to treat metastatic NSCLC By PBR Staff Writer The designation enables to use of JNJ-6372 to treat patients with metastatic NSCLC with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has advanced on
Clinical TrialsHuman Trials March 10, 2020 Kala’s dry eye disease candidate KPI-121 meets objective in STRIDE 3 trial By PBR Staff Writer Planned to be branded as EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, KPI-121 showed statistically significant results for primary and also key secondary endpoints in comparison to placebo in
RegulationApprovals March 6, 2020 Zydus secures DCGI approval for Saroglitazar to treat liver disease By PBR Staff Writer NASH, a progressive disease of the liver, commences with fat accumulation in the liver and may lead to cirrhosis and liver failure. Saroglitazar is claimed to be the
Drug DiscoveryResearch & Development March 4, 2020 Iktos, SRI join forces for AI-driven drug discovery to combat COVID-19 and other viruses By PBR Staff Writer As part of the collaboration, the AI-driven generative modelling technology of Iktos will be combined with SynFini, a fully automated end-to-end synthetic chemistry system developed by SRI. The
RegulationApprovals March 4, 2020 Alnylam gets EC nod for Givlaari to treat acute hepatic porphyria By PBR Staff Writer Givlaari, an injection for subcutaneous use, is an RNAi therapeutic that targets aminolevulinic acid synthase 1 (ALAS1) to treat AHP, an ultra-rare condition where patients experience severe abdominal
Drug DiscoveryResearch & Development March 3, 2020 Gilead Sciences to buy immuno-oncology firm Forty Seven for $4.9bn By PBR Staff Writer Forty Seven is engaged in the development of novel checkpoint therapies to stimulate macrophages for the treatment of cancer. The deal is expected to strengthen Gilead’s immuno-oncology research