Bioniz Therapeutics has announced positive data from a phase 1/2 clinical trial of BNZ-1 for the treatment of relapsed or refractory cutaneous T-cell lymphoma (rCTCL). BNZ-1 is an immuno-modulator drug candidate. It is a multi-cytokine inhibitor of three interleukins, that includes IL-2, IL-9, and IL-15. It is the lead asset from Bioniz Therapeutics’ platform of […]
US-based clinical service company WCG has acquired Trifecta Clinical, a provider of technology-enabled clinical trial solutions for an undisclosed price. The acquisition includes Trifecta Clinical’s site communication platform InvestigatorSpace, virtual training programs, and also safety documentation services. WCG provides solutions for improving the quality and efficiency of clinical research. The acquisition of Trifecta will expand […]
Geographic atrophy treatment : Janssen Pharmaceuticals has signed a licensing deal to acquire rights to HMR59, an investigational gene therapy for geographic atrophy, from clinical stage ocular gene therapy company Hemera Biosciences for an undisclosed price. HMR59 is intended to be given as a one-time, outpatient, intravitreal injection for helping in preserving vision in patients […]
Appili Therapeutics said that it has dosed the first participant in the phase 3 PRESECO clinical trial for Avigan tablets (favipiravir) for the oral treatment of Covid-19. The Canadian infectious disease biopharma company Appili is involving PRA Health Sciences as a clinical research organization (CRO) for administering the Covid-19 clinical trial at 47 outpatient sites. […]
The UK has given a temporary authorization for emergency use for the BNT162b2 Covid-19 vaccine candidate developed by Pfizer and BioNTech. The emergency use authorization (EUA) from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for the mRNA vaccine candidate follows the release of positive results of a global phase 3 trial. Pfizer and […]
Sedana Medical has submitted an application seeking approval for its drug candidate Sedaconda (isoflurane), previously called IsoConDa, for inhaled sedation in intensive care. The application has been filed with the German Medicines Agency BfArM and various other European Medicines Agencies via the DCP procedure. The market approval application is based on the results of the […]
Sage Therapeutics has secured a global collaboration and licensing deal worth up to $3.1 billion with Biogen for two of its drug candidates intended for the treatment of depression and movement disorders. Under the terms of the deal, the two US pharma companies will jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder (MDD), […]
Roxadustat approval – Astellas Pharma and FibroGen have secured approval for EVRENZO (roxadustat) in Japan for the treatment of anemia associated with chronic kidney disease (CKD) in adults, who are not on dialysis. The approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) is the second in the country for roxadustat through the […]
Pegunigalsidase alfa (PRX–102) update : Protalix BioTherapeutics said that the US Food and Drug Administration (FDA) has extended the prescription drug user fee act (PDUFA) date for review of pegunigalsidase alfa (PRX–102) as a treatment of adults with Fabry disease. The PDUFA action date for reviewing the company’s biologics license application (BLA) has been extended […]
Haoma Medica has wrapped up a first-in-human trial for NaQuinate, a naphthoquinone carboxylic acid, which is being developed as an oral treatment for osteoporosis. The UK-based biotech company initiated the human trial of NaQuinate last year in healthy adults for assessing its single and multiple doses. The primary goal of the trial was to evaluate […]