RegulationApprovals June 30, 2020 GSK’s Duvroq gets Japanese approval for anaemia caused by CKD By PBR Staff Writer Duvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which is yet to be approved for any indication anywhere else in the world with the exception of Japan.
Production & SalesManufacturing June 29, 2020 Carlyle Group to acquire 20% stake in India-based Piramal Pharma for $490m By PBR Staff Writer Piramal Pharma comprises four businesses, which includes a contract development and manufacturing (CDMO) business called Piramal Pharma Solutions. The pharma group also runs a complex hospital generics business
RegulationApprovals June 25, 2020 NeuroRx, Relief Therapeutics secure FDA fast track status for Covid-19 drug candidate By PBR Staff Writer RLF-100 is a synthetic form of human vasoactive intestinal peptide (VIP), which minimises inflammation in the lungs and protects the alveolar type II cells that are considered to
Clinical TrialsHuman Trials June 23, 2020 Merck’s V114 pneumococcal vaccine candidate succeeds in two phase 3 trials By PBR Staff Writer Both the late-stage trials – PNEU-WAY and PNEU-FLU evaluated the safety, tolerability, and immunogenicity of V114, said Merck. The investigational vaccine is being developed for the prevention of
RegulationApprovals June 18, 2020 Novartis gets FDA approval for Cosentyx to treat active non-radiographic axial spondyloarthritis By PBR Staff Writer The approval is said to confirm the Cosentyx efficacy in the treatment of axial spondyloarthritis (axSpA) disease spectrus. Cosentyx is claimed to be the first and only fully-human
RegulationApprovals June 15, 2020 FDA approves dispersible tablet formulation of dolutegravir for HIV in children By PBR Staff Writer The approval allows the dispersible tablet formulation of dolutegravir, in combination with other antiretroviral treatments, to be used in treatment-naïve paediatric patients aged more than four weeks and
RegulationApprovals June 11, 2020 Vertex gets EC nod for Kalydeco to treat children and adolescents with cystic fibrosis By PBR Staff Writer The approval allows Kalydeco to be used for the treatment of children and adolescents with CF aged between six months and older with a weight of at least
Production & SalesManufacturing June 10, 2020 FUJIFILM to invest $928m to expand Danish biologics production facility By PBR Staff Writer The investment will be made in the Danish site of FUJIFILM Diosynth Biotechnologies with an aim to double the drug substance production capacity of the biologics production facility.
Drug DiscoveryResearch & Development June 8, 2020 AbbVie, HBM, UU, and EMC to develop Covid-19 antibody therapeutic By PBR Staff Writer The US-Dutch collaboration will focus on advancing 47D11, a fully human, neutralising antibody therapeutic candidate. Discovery of the antibody was reported last month by Utrecht University, Erasmus Medical
RegulationMarketing Authorisation June 5, 2020 Janssen gets EC approval for subcutaneous use of daratumumab By PBR Staff Writer According to Janssen, the subcutaneous formulation of daratumumab is administered as a fixed dose, which considerably brings down treatment time, from hours to nearly three to five minutes,