Clinical TrialsHuman Trials December 9, 2020 AstraZeneca’s AZD1222 Covid-19 vaccine candidate delivers 70% efficacy By PBR Staff Writer The interim analysis for the efficacy of the AZD1222 vaccine candidate was based on 11,636 volunteers accruing 131 symptomatic infections from the phase 3 trials in the UK
RegulationApprovals December 9, 2020 Amgen’s sotorasib gets FDA breakthrough therapy status to treat advanced KRAS G12C-mutant NSCLC By PBR Staff Writer Sotorasib, which is claimed to be the first KRAS G12C inhibitor to enter the clinic, is being assessed in the wide clinical programme examining 10 combinations with global
Clinical TrialsHuman Trials December 8, 2020 Inovio doses first patient in phase 2 segment of Covid-19 DNA vaccine candidate trial By PBR Staff Writer The phase 2 segment has been designed to assess the safety and immunogenicity of INO-4800 Covid-19 vaccine candidate to confirm the dose for the subsequent efficacy assessment as
Clinical TrialsHuman Trials December 7, 2020 Sinovac receives up to $500m for Covid-19 vaccine development By PBR Staff Writer Via its affiliates, the investor Sino Biopharmaceutical has invested around $500m in exchange for about 15% of the total equity interest of Sinovac LS. Earlier to the announcement
Drug DiscoveryResearch & Development December 4, 2020 Janssen acquires rights to Hemera’s investigational eye-disorder gene therapy By PBR Staff Writer HMR59 is being developed to administer as a one-time, outpatient and intravitreal injection to protect vision in patients with geographic atrophy, a late-stage and severe form of age-related
Clinical TrialsPatient Enrollment December 3, 2020 Appili announces dosing of first patient in phase 3 Covid-19 trial By PBR Staff Writer PRA Health Sciences, a clinical research organisation (CRO) selected by Appili, will conduct the trial at 47 outpatient sites. Avigan, which is an antiviral in oral tablet form
RegulationApprovals December 3, 2020 UK regulator grants EUA status for Pfizer and BioNTech’s Covid-19 mRNA vaccine By PBR Staff Writer The BNT162b2 mRNA vaccine is said to be the first in the world to secure EUA status to fight against Covid-19. The status was provided by the UK
Clinical TrialsHuman Trials December 2, 2020 Amgen, Takeda, UCB enrol first patient in Covid-19 global platform study By PBR Staff Writer Three drugmakers are part of the COVID R&D Alliance, which was established in March this year to boost the study candidates without regard to company affiliation. The alliance,
RegulationDrug Filing December 1, 2020 Moderna seeks FDA EUA for Covid-19 vaccine candidate By PBR Staff Writer The mRNA-1273 is an mRNA vaccine against Covid-19 encoding for a prefusion stabilised form of the Spike (S) protein. It was co-developed by Moderna and investigators from NIAID’s
Clinical TrialsPatient Enrollment December 1, 2020 NeoImmuneTech doses first patient in Covid-19 trial By PBR Staff Writer The company-sponsored study is being carried out in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and