RegulationApprovals August 10, 2020 Roche gets FDA nod for Evrysdi to treat spinal muscular atrophy By PBR Staff Writer Evrysdi is a survival of motor neuron 2 (SMN2) splicing modifier created for the treatment of SMA caused by mutations in chromosome 5q, which lead to SMN protein
RegulationApprovals August 7, 2020 ViiV Healthcare gets FDA expanded approval for HIV-1 drug Dovato By PBR Staff Writer The approval will enable ViiV Healthcare to use the complete regimen as a replacement for the current antiretroviral (ARV) regimen in adults who are virologically suppressed on a
RegulationApprovals August 6, 2020 GSK secures FDA nod for BLENREP to treat relapsed or refractory multiple myeloma By PBR Staff Writer BLENREP has been approved as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have secured at least four prior therapies including an anti-CD38
RegulationApprovals August 5, 2020 ReViral secures FDA fast track status for sisunatovir to treat severe RSV infection By PBR Staff Writer Sisunatovir is an orally administered fusion inhibitor designed to inhibit RSV replication by suppressing RSV F-mediated fusion of RSV with the host cell. RSV is a respiratory pathogen
RegulationApprovals July 31, 2020 Takeda gets FDA breakthrough therapy status for pevonedistat to treat higher-risk HR-MDS By PBR Staff Writer MDS is a rare form of bone marrow-related cancer, which will be resulted due to irregular blood cell production within the bone marrow. Pevonedistat, a first-in-class NEDD8-activating enzyme
Clinical TrialsHuman Trials July 30, 2020 Roche’s tocilizumab fails to achieve primary endpoints for Covid-19-related pneumonia By PBR Staff Writer The phase III COVACTA study of tocilizumab did not reach its primary endpoint of improved clinical status in hospitalised adult patients with severe Covid-19 associated pneumonia. Roche’s trial
Production & SalesManufacturing July 29, 2020 DFC grants $765m loan to Kodak to establish new pharma business unit By PBR Staff Writer The US technology company signed a letter of interest (LOI) with the DFC to secure a loan to establish Kodak Pharmaceuticals, a new business unit that will engage
Clinical TrialsHuman Trials July 28, 2020 Pfizer, BioNTech begin phase 2/3 Covid-19 trial with BNT162b2 vaccine candidate By PBR Staff Writer Both companies have decided to advance their BNT162b2 vaccine candidate into the phase 2/3 study at a 30µg dose level in a two-dose regimen after an extensive assessment
Drug DiscoveryResearch & Development July 27, 2020 Daiichi Sankyo, AstraZeneca sign $6bn worth deal for DS-1062 By PBR Staff Writer Currently, DS-1062 is being developed for the treatment of non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). The TROP2 directed DXd antibody drug conjugate (ADC) is
News July 27, 2020 Gilead’s Kite gets FDA nod for Tecartus to treat relapsed or refractory MCL By PBR Staff Writer Tecartus, earlier known as KTE-X19, is claimed to be the first and only approved chimeric antigen receptor (CAR) T cell therapy to treat relapsed or refractory MCL. Tecartus,