RegulationApprovals November 22, 2019 FDA approves AstraZeneca’s Calquence to treat lymphocytic cancers By PBR Staff Writer Calquence, which is a next-generation selective inhibitor of Bruton’s tyrosine kinase (BTK), binds covalently to BTK to inhibit its activity. The FDA approval was based on data from
RegulationApprovals November 20, 2019 Janssen gets EC approval for Darzalex combination regimen to treat multiple myeloma By PBR Staff Writer Daratumumab is a first-in-class biologic designed to target CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage. Daratumumab is considered to
Drug DiscoveryResearch & Development November 19, 2019 Dicerna, Novo Nordisk sign RNAi deal for liver-related cardio-metabolic diseases By PBR Staff Writer In this regard, the companies will make use of GalXC, an RNA interference (RNAi) technology platform developed by Dicerna, for the discovery of new therapies. The collaboration will
RegulationApprovals November 15, 2019 Shionogi gets FDA approval for cUTI drug Fetroja By PBR Staff Writer Fetroja has been approved for patients 18 years of age or older who have limited or no alternative treatment options to treat cUTI, including pyelonephritis. It can be
Drug DiscoveryResearch & Development November 14, 2019 Merck to acquire Calporta Therapeutics for $576m By PBR Staff Writer The transaction includes an upfront payment and contingent milestone payments. Calporta is involved in the development of selective small-molecule agonists to TRPML1 (transient receptor potential cation channel, mucolipin
Clinical TrialsHuman Trials November 13, 2019 Boehringer, Eli Lilly begin sixth phase III study for Jardiance in heart failure By PBR Staff Writer The Empulse, which is the sixth phase III study in the Jardiance heart failure programme, will evaluate whether in-hospital administration of Jardiance 10mg daily enhances heart failure outcomes
Clinical TrialsHuman Trials November 12, 2019 Roche’s risdiplam meets primary endpoint in phase 3 SMA trial By PBR Staff Writer Risdiplam has been designed to be a survival motor neuron-2 (SMN2) splicing modifier. The drug works by durably increasing and maintaining SMN protein levels throughout the central nervous
RegulationApprovals November 11, 2019 FDA approves Reblozyl for treatment of anaemia in beta thalassemia By PBR Staff Writer Reblozyl is an erythroid maturation agent, which was co-developed by Celgene and Acceleron Pharma. According to Celgene, the FDA-approved drug is a new class of therapy that has
Drug DiscoveryResearch & Development November 7, 2019 Regeneron, Vyriad sign deal to develop oncolytic virus-based treatments By PBR Staff Writer Both firms will also sign a five-year research agreement to use Regeneron’s VelociSuite technologies to jointly design and validate Vesicular Stomatitis Virus (VSV)-based oncolytic virus treatments. Under the
Clinical TrialsHuman Trials November 5, 2019 Halozyme’s PEGPH20 pancreas cancer drug candidate fails in HALO-301 trial By PBR Staff Writer PEGPH20 was being assessed in combination with ABRAXANE (nab-paclitaxel) and gemcitabinein in the HALO-301 study as a first-line therapy for the condition. The late-stage trial enrolled 500 patients