Adults

Janssen Presents Results of Nipocalimab (M281) in P-II Vivacity-MG Study for Adults with Generalized Myasthenia Gravis at AAN2021

Shots: The P-II Vivacity-MG study involves assessing the safety, tolerability, efficacy, PK, PD, and immunogenicity of nipocalimab in addition to SoC vs PBO in a ratio (1:1:1:1:1) in 68 patients with gMG The 1EPs of the study include safety, tolerability, and efficacy assessed by (MG-ADL) ADL score. The 2EPs includes the efficacy as measured by …

Janssen Presents Results of Nipocalimab (M281) in P-II Vivacity-MG Study for Adults with Generalized Myasthenia Gravis at AAN2021 Read More »

Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for Adults with Relapsed and Refractory Multiple Myeloma

Shots: The approval is based on data from the P-III IKEMA study evaluating Sarclisa + carfilzomib and dexamethasone (Kd) vs Kd alone in 302 patients with relapsed MM across 69 centers spanning 16 countries Results: mPFS (not reached vs 19.15 mos.) at the time of the pre-planned interim analysis, reduction in the risk of disease …

Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for Adults with Relapsed and Refractory Multiple Myeloma Read More »

Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children

Shots: The approval is based on two studies i.e. FIREFISH & SUNFISH. The FIREFISH study involves assessing Evrysdi in infants aged 2-7mos. with symptomatic Type 1 SMA, and the SUNFISH study assesses Evrysdi in children & young adults aged 2-25yrs. with Type 2 or 3 SMA Evrysdi demonstrated improvement in motor function, 29.3% of participants …

Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children Read More »

Vir and GSK Provide Update on ACTIV-3 Trial of VIR-7831 in Hospitalized Adults with COVID-19

Shots: The DSMB has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. The recommendation was based on pre-planned safety & efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3 The companies will continue discussions with the NIH to further assess the potential …

Vir and GSK Provide Update on ACTIV-3 Trial of VIR-7831 in Hospitalized Adults with COVID-19 Read More »

Otsuka and Click Initiate Digital Study in Adults with Major Depressive Disorder

Shots: Otsuka and Click have reported the initiation of the Mirai study which is a fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing depressive symptoms in adults diagnosed with MDD who are on antidepressant monotherapy. The study will enroll ~540 patients globally The trial will run fully remotely utilizing the …

Otsuka and Click Initiate Digital Study in Adults with Major Depressive Disorder Read More »

Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Shots: The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, 75% improvement in BSA, change in PASI score Otezla is …

Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis Read More »

Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

Shots: The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one maintenance dosing option while the efficacy, safety, and tolerability were observed during 7 maintenance infusions @3wks. intervals over a 6mos. period The study met 1EPs i.e. 80% of patients achieved …

Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy Read More »

ViiV Healthcare’s Rukobia (fostemsavir) Receives Marketing Authorization for the Treatment of Adults with Multidrug-Resistant HIV

Shots: The MAA is based on P-III BRIGHTE study assessing Rukobia (600mg, bid) + OBT vs PBO in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort In the randomized cohort, 60% achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 …

ViiV Healthcare’s Rukobia (fostemsavir) Receives Marketing Authorization for the Treatment of Adults with Multidrug-Resistant HIV Read More »

BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for Adults With R/R Large-B-Cell Lymphoma

Shots: The approval is based on pivotal TRANSCEND NHL 001 (017001) study assessing Breyanzi in 268 patients with 3L+R/R LBCL including patients with a broad range of histologies and high-risk disease. Breyanzi was administered in the inpatient & outpatient settings Results: ORR (73%); CR (54%); PR (19%); mDOR (16.7mos.) in all responders; patients with best …

BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for Adults With R/R Large-B-Cell Lymphoma Read More »

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

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 …

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes Read More »

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

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 …

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps Read More »

Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status

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 …

Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status Read More »

GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

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 …

GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020 Read More »

MC2 Therapeutics Wynzora Cream Receives the US FDA’s Approval to Treat Plaque Psoriasis in Adults

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 …

MC2 Therapeutics Wynzora Cream Receives the US FDA’s Approval to Treat Plaque Psoriasis in Adults Read More »

Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

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 …

Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children Read More »