Clinical TrialsPatient Enrollment July 8, 2020 Ridgeback begins enrolment for phase 2 Covid-19 trial of EIDD-2801 By PBR Staff Writer The trial of EIDD-2801 will be held using a newly launched Covid-19 drug testing platform called AGILE, which has been developed in the UK by the University of
Clinical TrialsHuman Trials July 7, 2020 Sunovion’s SEP-4199 fails to meet primary endpoint in SEP380-201 trial By PBR Staff Writer The primary endpoint of the SEP380-201 trial was the variation from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score after six weeks of treatment with SEP-4199. According
News July 6, 2020 Ascentage, MSD to study APG-115, KEYTRUDA combo in advanced solid tumours By PBR Staff Writer APG-115 has been designed by Ascentage Pharma as an orally administered, selective, small-molecule inhibitor of the MDM2-p53 PPI. KEYTRUDA, on the other hand, is an anti-PD-1 therapy, which
RegulationApprovals July 3, 2020 ViiV Healthcare gets FDA nod for HIV drug Rukobia to treat adult patients By PBR Staff Writer Rukobia is a novel attachment inhibitor, which is designed to treat HIV-1 infection, is specified for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE)
RegulationApprovals July 2, 2020 Janssen gets EC approval for Ebola vaccine regimen By PBR Staff Writer As a result of the approval, Janssen is currently collaborating with the World Health Organisation (WHO) on vaccine pre-qualification to advance the registration of its preventive Ebola vaccine
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