RegulationDrug Filing April 30, 2019 ViiV Healthcare seeks FDA approval for cabotegravir plus rilpivirine to treat HIV By PBR Staff Writer The company has submitted a new drug application (NDA) to the FDA for two-drug regimen to treat HIV-1 infection in adults whose viral load is suppressed and who
RegulationDrug Filing April 29, 2019 Celgene seeks EMA approval for luspatercept for anemia associated with MDS and beta-thalassemia By PBR Staff Writer Luspatercept is an erythroid maturation agent (EMA), which has been designed to regulate late-stage red blood cell maturation. The drug is being jointly developed by Acceleron and Celgene
Clinical TrialsHuman Trials April 26, 2019 Gilead’s selonsertib fails to meet primary endpoint in Phase 3 NASH study By PBR Staff Writer Stellar-3 is a randomized, double-blind and placebo-controlled trial, which assessed the safety and efficacy of selonsertib in patients with bridging fibrosis (F3) due to NASH. According to the
Production & SalesManufacturing April 25, 2019 GSK invests $100m to boost vaccine manufacturing at US facility By PBR Staff Writer The investment will help GSK to expand the production capacity of major components of the adjuvant system used in several of its vaccines such as Shingrix, which secured
Clinical TrialsHuman Trials April 24, 2019 Lilly’s Taltz meets primary endpoint in phase 3 nr-axSpA trial By PBR Staff Writer Taltz met the primary and all key secondary endpoints in the late-stage trial, called COAST-X. The 52-week trial evaluated the safety and efficacy of the psoriatic arthritis drug
RegulationApprovals April 23, 2019 FDA approves Merck’s Keytruda plus Inlyta to treat advanced renal cell carcinoma By PBR Staff Writer Keytruda is an anti-PD-1 therapy, while Inlyta is a tyrosine kinase inhibitor. Keytruda will help enhance the ability of the body’s immune system to detect and combat tumor
Drug DiscoveryResearch & Development April 17, 2019 Gilead, insitro collaborate to develop therapies for nonalcoholic steatohepatitis By PBR Staff Writer Under the three-year deal, the partnership will use insitro’s platform to create disease models for NASH and discover targets that can impact clinical progression and regression of the
Drug DiscoveryResearch & Development April 16, 2019 Catalent to buy CDMO Paragon Bioservices for $1.2bn By PBR Staff Writer Paragon Bioservices is a major viral vector development and manufacturing partner for gene therapies. Paragon president and CEO Pete Buzy said: “We are excited to join forces with
RegulationDrug Filing April 16, 2019 FDA accepts Novartis’s BLA for brolucizumab for treatment of wet AMD By PBR Staff Writer The company said that it used a priority review voucher to fast track the review of the regulator on brolucizumab in order to make it available to patients
RegulationApprovals April 15, 2019 Janssen’s Balversa gets FDA approval for metastatic bladder cancer By PBR Staff Writer Balversa is now indicated in the US for the treatment of adult patients having locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration