Comparative Risk of Arterial Thromboembolic Events Between Aflibercept and Ranibizumab in Patients with Maculopathy: A Population-Based Retrospective Cohort Study
ConclusionThe use of aflibercept in patients with maculopathy was associated with a lower risk of ATE than was the use of ranibizumab. There was no difference in mortality risk between the two groups. Our study could provide strong grounds for future prospective studies to confirm the findings. (Source: BioDrugs)
Source: BioDrugs - September 8, 2021 Category: Drugs & Pharmacology Source Type: research

Cryopreservation of NK and T Cells Without DMSO for Adoptive Cell-Based Immunotherapy
AbstractDimethylsufoxide (DMSO) being universally used as a cryoprotectant in clinical adoptive cell-therapy settings to treat hematological malignancies and solid tumors is a growing concern, largely due to its broad toxicities. Its use has been associated with significant clinical side effects —cardiovascular, neurological, gastrointestinal, and allergic—in patients receiving infusions of cell-therapy products. DMSO has also been associated with altered expression of natural killer (NK) and T-cell markers and their in vivo function, not to mention difficulties in scaling up DMSO-based cryoprotectants, which introduce...
Source: BioDrugs - August 24, 2021 Category: Drugs & Pharmacology Source Type: research

Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review
ConclusionsThe current research evidence on the automatic substitution of biologics is scarce and of low to moderate quality, reflecting low stakeholder knowledge and their cautious attitude towards biosimilars. The safe and efficient implementation of automatic substitution requires well-designed practices, pilot studies, and evolving legislation. (Source: BioDrugs)
Source: BioDrugs - August 16, 2021 Category: Drugs & Pharmacology Source Type: research

Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product
ConclusionsBased on these results, it can be concluded that ABP  959 is analytically similar to eculizumab RP. (Source: BioDrugs)
Source: BioDrugs - July 22, 2021 Category: Drugs & Pharmacology Source Type: research

Advances in Immunotherapy for Diffuse Large B Cell Lymphoma
AbstractDiffuse large B cell lymphoma (DLBCL) is a heterogeneous disease that is normally treated with combination chemotherapy combined with the anti-CD20 monoclonal antibody rituximab. Although about two-thirds of patients are cured with initial chemo-immunotherapy, a sizable minority of patients will have relapsed or refractory (r/r) DLBCL. Standard therapy for r/r DLBCL is salvage chemotherapy followed by autologous stem cell transplantation (ASCT); however, a minority of patients have long-term remission with this approach. In recent years, there has been a proliferation of immunotherapies for the treatment of DLBCL t...
Source: BioDrugs - July 15, 2021 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC)
ConclusionsEfficacy equivalence was demonstrated between the two drugs, and safety profiles were similar. There were no meaningful differences in efficacy and safety between FKB238 or bevacizumab in patients with non-sq-NSCLC.Trial registration numberNCT02810457. (Source: BioDrugs)
Source: BioDrugs - July 15, 2021 Category: Drugs & Pharmacology Source Type: research

Novel Targeted Biological Agents for the Treatment of Atopic Dermatitis
AbstractAtopic dermatitis (AD) is a common inflammatory dermatologic disease clinically characterized by intense itch, recurrent eczematous lesions, and a chronic or relapsing disease course. Mild-to-moderate AD can be controlled by using moisturizers and topical immunomodulators such as topical corticosteroids and calcineurin inhibitors. If topical therapies fail, phototherapy and systemic immunosuppressant therapies, such as ciclosporin, methotrexate, and azathioprine, can be considered. However, relapse and side effects could still occur. The pathogenesis of AD involves epidermal barrier dysfunction, skin microbiome abn...
Source: BioDrugs - July 2, 2021 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC)
ConclusionsEfficacy equivalence was demonstrated between the two drugs, and safety profiles were similar. There were no meaningful differences in efficacy and safety between FKB238 or bevacizumab in patients with non-sq-NSCLC.Trial registration numberNCT02810457. (Source: BioDrugs)
Source: BioDrugs - July 1, 2021 Category: Drugs & Pharmacology Source Type: research

Restoring Protein Expression in Neuromuscular Conditions: A Review Assessing the Current State of Exon Skipping/Inclusion and Gene Therapies for Duchenne Muscular Dystrophy and Spinal Muscular Atrophy
AbstractThe debilitating neuromuscular disorders Duchenne muscular dystrophy (DMD) and spinal muscular atrophy (SMA), which harm 1 in 5000 newborn males and 1 in 11,000 newborns, respectively, are marked by progressive muscle wasting among other complications. While DMD causes generalized muscle weakness due to the absence of the dystrophin protein, SMA patients generally face motor neuron degeneration because of the lack of the survival motor neuron (SMN) protein. Many of the most promising therapies for both conditions restore the absent proteins dystrophin and SMN. Antisense oligonucleotide-mediated exon skipping and in...
Source: BioDrugs - July 1, 2021 Category: Drugs & Pharmacology Source Type: research