Shots: Abbott’s next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received Health Canada’s approval for adults & children with diabetes The system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high/low without scanning The technology sustains performance for ~14days, providing trends, insights & actionable data […]Read More
Shots: The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs […]Read More
Shots: The companies present the findings from a new exploratory sub-analysis of the P-III EMPEROR-Reduced study demonstrating that Jardiance (empagliflozin) reduced the risk of adverse CV by 25% and kidney events by 50% in adults with HFrEF with/out diabetes regardless of CKD status at ASN Week 2020 In all patient cohorts participating in the EMPEROR-Reduced […]Read More
Shots: GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults […]Read More
Shots: The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer, and other RET-altered solid tumors Results: ORR (57%) and CR rate (5.7%) […]Read More
Shots: The US FDA has approved Evrysdi to treat SMA in adults and children ≥ 2mos. The approval is based on two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic infants aged 2-7 mos, and SUNFISH in children and adults aged 2-25yrs. The two studies demonstrated improvements […]Read More
The approval is based on P-III trial assessing Wynzora Cream vs Taclonex Topical Suspension in 794 patients for the treatment of plaque psoriasis in adults 18 years of age or older The study resulted in a PGA treatment of 21.6% vs 14.6%, patients achieved at least a 4-point improvement in the peak pruritus NRS score […]Read More
Shots: The TGA authorization follows the recent data shared by EMA and Singapore Health Sciences Authority for remdesivir’s approval in EU, Singapore and, Japan for COVID-19 patients TGA’s approval was made within 2 weeks of the receipt of the submission while the provisional approval is based on preliminary data valid for 6 years. Additionally, the […]Read More
Shots: The BLA submission is based on P-III ECZTRA 1 & 2 studies assessing tralokinumab (300mg, SC) as monothx. vs PBO in 804 & 794 adults with mod. to sev. AD who were candidates for systemic therapy for 52wks. respectively The submission also follows the P-III ECZTRA 3 study assesses the safety and efficacy of […]Read More
The approval is based on P-III trial assessing Upneeq vs PBO in 2:1 ratio in 140 patients with acquired blepharoptosis split into two treatment groups for 42 days. Additionally, another second P-III clinical trial evaluated safety and efficacy of Upneeq vs PBO in 35 patients to treat acquired blepharoptosis The study resulted in well tolerated […]Read More
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