Shots: The approval is based on P-III IRIDIUM study assessing Enerzair Breezhaler (qd) vs Atectura Breezhaler (QMF149; IND/MF) in 3092 patients in the ratio (1:1:1:1) whose asthma is uncontrolled with […]readmore
Tags : Novartis
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it The outbreak of the respiratory disease was first detected […]readmore
Shots: The five therapies include Tabrecta (capmatinib) for advanced and recurrent unresectable NSCLC, Entresto (sacubitril valsartan sodium hydrate) for chronic HF, Mayzent (siponimod fumaric acid) for secondary PMS, Enerzair (glycopyrronium […]readmore
1. EMA’s CHMP Recommends the Approval of Two Biosimilar Referencing Lilly’s Forsteo (teriparatide) for the Treatment of Osteoporosis Published: Jun 26, 2020 | Tags: EMA, CHMP, Recommend, Approval, Two, Biosimilar, Referencing, […]readmore
Shots: Novartis has discontinued its clinical trial HCQs due to feasibility of recruitment. The recruitment challenge has made it unlikely that the clinical team will be able to collect meaningful […]readmore
The US FDA has approved multiple NDAs and BLAs in May 2020, leading to the treatments for patients and advances in the health care industry The Center for Drug Evaluation […]readmore
Shots: The approval is based on P-III PREVENT study assessing the safety and efficacy of Cosentyx (150mg with/out loading dose) vs PBO in 555 adult patients with active nr-axSpA that […]readmore
1. Novartis Reports Results of Enerzair Breezhaler (QVM149) in P-IIIb ARGON Study to Treat Uncontrolled Asthma Published: Jun 04, 2020 | Tags: Novartis, Reports, Enerzair Breezhaler, QVM149, P-IIIb, ARGON Study, Treat, […]readmore
Shots: The P-IIIb ARGON study involves assessing of IND/GLY/MF (150/50/80 μg , 150/50/160 μg, qd) with Sal/Flu (50/500μg, bid) delivered via Diskus + tiotropium (5 μg), delivered via Respimat in […]readmore
The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019. However, there is […]readmore