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 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 August 3, 2020 Novartis gets EC nod for Cosentyx drug in paediatric psoriasis By PBR Staff Writer Psoriasis, a life-long systemic inflammatory disease, is said to significantly affect the patients’ quality of life, both physically and emotionally. Cosentyx is claimed to be the first and
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
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
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
Clinical TrialsHuman Trials July 24, 2020 Humanetics gets financing from NIAID to study BIO 300 drug in Covid-19 patients By PBR Staff Writer NIAID is part of the National Institutes of Health, which is an agency of the US Department of Health and Human Services. The trial will target patients who
Drug DiscoveryResearch & Development July 22, 2020 Gilead Sciences to buy 49.9% stake in Tizona Therapeutics for $300m By PBR Staff Writer Gilead is also provided with an exclusive option to purchase the remaining stake in Tizona for up to an additional $1.2bn. The deal is also comprised of an
Drug DiscoveryResearch & Development July 21, 2020 GSK to acquire 10% stake in German biotech company CureVac By PBR Staff Writer The companies have signed a collaboration agreement for the research, development, manufacturing and commercialisation of up to five messenger RNA (mRNA)-based vaccines and monoclonal antibodies (mAbs) to eliminate
Clinical TrialsHuman Trials July 20, 2020 Celltrion begins Covid-19 human clinical trial with antiviral antibody treatment By PBR Staff Writer The in-human study follows positive pre-clinical results for the treatment candidate, as well as successive approval of the investigational new drug application by the Korean Ministry of Food