An investigational one-time gene therapy for the treatment of adults with severe haemophilia A has been proven to be effective for more than three years from treatment. BioMarin Pharmaceutical revealed the positive results from its ongoing global Phase III GENEr8-1 study of Roctavian (valoctocogene roxaparvovec). … Read More
Airsupra (albuterol/budesonide) has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra is a pressurised metered-dose inhaler (pMDI), fixed-dose combination of albuterol, a short-acting beta2-agonist (SABA),… Read More
Celltrion USA has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for CT-P13 SC for the treatment of inflammatory bowel disease (IBD). The submission is based on results from the Phase III pivotal data that evaluated the efficacy and… Read More
A new type of targeted medicine has shown ‘remarkable’ benefits for patients with advanced breast cancer in a major Phase III clinical trial. The drug capivasertib combined with hormone therapy doubled the time it took for cancer to progress in people with advanced forms of the most… Read More
A Phase III trial has demonstrated that Jardiance (empagliflozin) is the first SGLT2 inhibitor to show a reduction in blood sugar levels in children and adolescents with type 2 diabetes. The DINAMO Phase III clinical trial demonstrated a statistically significant reduction in HbA1c with empagliflozin compared with… Read More
Novartis and Medicines for Malaria Venture (MMV) will progress ganaplacide/lumefantrine-solid dispersion formulation (SDF) into Phase III development for the treatment of patients with malaria due to Plasmodium falciparum. Ganaplacide is a novel agent with a new mechanism of action, which is combined with a new formulation of… Read More
The UK Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Novartis’ Cosentyx (secukinumab) in two types of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA). The drug is approved alone or in combination with methotrexate (MTX) in… Read More
The US Food and Drug Administration (FDA) has approved the Phase III clinical trial design for BRIM Biotechnology’s lead candidate for dry eye disease (DED), BRM421. BRIM will submit the Phase III study protocol to the FDA later this year. BRM421 is a novel, first-in-class regenerative peptide… Read More
Global Phase III topline data is expected later this year for a new class of Covid-19 booster vaccine. Vaxxinity has completed enrollment for the trial, co-sponsored by the Coalition for Epidemic Preparedness Innovations (CEPI). Its UB-612 will be evaluated as a heterologous booster vaccine to mRNA, adeno-vectored, and inactivated primary… Read More
The National Institute for Health and Care Excellence (NICE) has published final guidance recommending Ryeqo (relugolix 40mg, estradiol 1mg, and norethisterone acetate 0.5mg), for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The decision makes the relugolix combination therapy… Read More
A new Alzheimer’s disease (AD) treatment has been shown to reduce clinical decline in mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology in the brain. Eisai and Biogen’s anti-amyloid beta (Aβ) protofibril antibody lecanemab met the primary endpoint and… Read More
