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Novavax gets Singapore’s HSA approval for prototype Covid-19 vaccine Nuvaxovid
Nuvaxovid is a protein-based ready-to-use vaccine developed by creating copies of the surface spike protein of SARS-CoV-2, a virus that is responsible for Covid-19
UCB obtains FDA approval for Bimzelx to treat plaque psoriasis
The approval is based on results from three Phase 3 clinical trials in which antibody delivered fast, complete and lasting levels of skin clearance for up to one year and was generally well-tolerated
FDA approves Ardelyx’s Xphozah for adults with chronic kidney disease
Xphozah is a single tablet, twice daily inhibitor with a differentiated mechanism of action that blocks phosphate absorption through its primary pathway
UCB gets FDA approval for Zilbrysq to treat generalised myasthenia gravis adults
The approval was based on the safety and efficacy data from the RAISE phase 3 study in which Zilbrysq delivered fast, consistent, and statistically significant benefits in different patient-and-clinician reported outcomes at week 12
Novo Nordisk to buy KBP’s hypertension drug ocedurenone for $1.3bn
Ocedurenone is currently being evaluated in the phase 3 CLARION-CKD trial in patients with uncontrolled hypertension and advanced chronic kidney disease
FDA grants RMAT status to Editas Medicine’s sickle cell disease therapy
EDIT-301 is an investigational, gene editing medicine which consists of patient derived CD34+ hematopoietic stem and progenitor cells edited at the gamma globin gene promoters
COMPAMED 2023, between the poles of top innovation and regulation
The med-tech supply sector shows off its “high-performance mode”
Better Therapeutics Announces Launch of AspyreRx to Treat Adults with Type 2 Diabetes
AspyreRx is the first FDA-authorized digital behavioral therapeutic device delivering cognitive behavioral therapy for the treatment of a cardiometabolic disease
GE HealthCare Signs $44 Million Contract with BARDA to Develop Artificial Intelligence-Augmented Ultrasound Technology to Aid Clinicians in Diagnosing and Treating Traumatic Injury and Enhance National Preparedness for Mass Casualty Incidents
GE HealthCare (Nasdaq: GEHC) today announced it signed a $44 million contract with the Biomedical Advanced Research and Development Authority (BARDA)—part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS)—to develop and obtain regulatory clearance for next-generation advanced point-of-care ultrasound technology with new artificial intelligence (AI) applications. Technology resulting from this jointly funded program will help healthcare professionals at all skill levels rapidly diagnose and provide timely treatment for patients with lung pathologies and traumatic injuries to the abdomen, chest and head.
AbbVie’s upadacitinib meets primary endpoint in Phase 2b trial in vitiligo
In the trial, Rinvoq showed a percent change from baseline in the Facial Vitiligo Area Scoring Index at week 24 with the 11mg and 22mg doses against placebo