Vosoritide: First Approval
This article summarizes the milestones in the development of vosoritide leading to this first approval for achondroplasia in patients aged ≥ 2 years whose epiphyses are not closed. (Source: Drugs)
Source: Drugs - October 25, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Sotorasib: First Approval
(Source: Drugs)
Source: Drugs - October 23, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Contezolid: First Approval
(Source: Drugs)
Source: Drugs - October 23, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Sotorasib: First Approval
(Source: Drugs)
Source: Drugs - October 23, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Contezolid: First Approval
(Source: Drugs)
Source: Drugs - October 23, 2021 Category: Drugs & Pharmacology Source Type: research

Difelikefalin: First Approval
This article summarizes the milestones in the development of difelikefalin leading to this first approval for CKD-associated pruritus in adults undergoing haemodialysis. (Source: Drugs)
Source: Drugs - October 21, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: REal worlD Effectiveness and Safety of Mepolizumab in a Multicentric Spanish Cohort of Asthma Patients Stratified by Eosinophils: The REDES Study
(Source: Drugs)
Source: Drugs - October 21, 2021 Category: Drugs & Pharmacology Source Type: research

Difelikefalin: First Approval
This article summarizes the milestones in the development of difelikefalin leading to this first approval for CKD-associated pruritus in adults undergoing haemodialysis. (Source: Drugs)
Source: Drugs - October 21, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: REal worlD Effectiveness and Safety of Mepolizumab in a Multicentric Spanish Cohort of Asthma Patients Stratified by Eosinophils: The REDES Study
(Source: Drugs)
Source: Drugs - October 21, 2021 Category: Drugs & Pharmacology Source Type: research

Disitamab Vedotin: First Approval
This article summarizes the milestones in the development of disitamab vedotin leading to this first approval for locally advanced or metastatic gastric cancer. (Source: Drugs)
Source: Drugs - October 18, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Hyperkalemia in Chronic Kidney Disease in the New Era of Kidney Protection Therapies
(Source: Drugs)
Source: Drugs - October 11, 2021 Category: Drugs & Pharmacology Source Type: research

The Antifungal Pipeline: Fosmanogepix, Ibrexafungerp, Olorofim, Opelconazole, and Rezafungin
AbstractThe epidemiology of invasive fungal infections is changing, with new populations at risk and the emergence of resistance caused by the selective pressure from increased usage of antifungal agents in prophylaxis, empiric therapy, and agriculture. Limited antifungal therapeutic options are further challenged by drug –drug interactions, toxicity, and constraints in administration routes. Despite the need for more antifungal drug options, no new classes of antifungal drugs have become available over the last 2 decades, and only one single new agent from a known antifungal class has been approved in the last ...
Source: Drugs - October 9, 2021 Category: Drugs & Pharmacology Source Type: research

Bimekizumab for the Treatment of Psoriasis
This article reviews the current knowledge about bimekizumab in psoriasis treatment. The results obtained in the phase 3 studies (BE VIVID, BE READY, BE RADIANT, BE SURE) corroborate the high levels of efficacy of bimekizumab seen in previous studies, and show superior efficacy over adalimumab, ustekinumab, and secukinumab in direct comparative studies. In all phase 3 trials, bimekizumab was also well tolerated, with a safety profile similar to the other biologic drugs tested, except for a higher frequency of oral candidiasis. Dual inhibition of IL-17A and IL-17F is a highly effective therapeutic option for the treatment o...
Source: Drugs - October 8, 2021 Category: Drugs & Pharmacology Source Type: research

Pharmacological Management of Acute Endodontic Pain
AbstractPain associated with infections of the tooth pulp and periapical tissues is intense and often the most common reason for patients seeking emergency dental care. Effective management of acute dental pain requires a deep understanding of pain mechanisms, which enables accurate diagnosis and definitive treatment. While drugs are only used as an adjunct to definitive dental treatment, a thorough understanding of their mechanism of action and effectiveness enables clinicians to effectively control intra-operative and post-operative pain and prevent persistent pain. This review describes how pain is detected, processed, ...
Source: Drugs - October 7, 2021 Category: Drugs & Pharmacology Source Type: research

Belzutifan: First Approval
This article summarizes the milestones in the development of belzutifan leading to this first approval for certain VHL disease-associated tumours. (Source: Drugs)
Source: Drugs - October 6, 2021 Category: Drugs & Pharmacology Source Type: research

Bruton ’s Tyrosine Kinase Inhibition as an Emerging Therapy in Systemic Autoimmune Disease
AbstractSystemic autoimmune disorders are complex heterogeneous chronic diseases involving many different immune cells. A significant proportion of patients respond poorly to therapy. In addition, the high burden of adverse effects caused by “classical” anti-rheumatic or immune modulatory drugs provides a need to develop more specific therapies that are better tolerated. Bruton’s tyrosine kinase (BTK) is a crucial signaling protein that directly links B-cell receptor (BCR) signals to B-cell activation, proliferation, and survival. BTK is not only expressed in B cells but also in myeloid cells, and is invo...
Source: Drugs - October 5, 2021 Category: Drugs & Pharmacology Source Type: research

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective
ConclusionsIn line with previous reports of prelicensing studies of biosimilar mAbs and etanercepts, this study demonstrated comparable efficacy, safety, and immunogenicity compared with the reference products. This is the first study to comprehensively analyze postmarketing surveillance data of the biosimilar mAbs and etanercept. An analysis of more than 1  million patient-treatment years of safety data raised no safety concerns. Based on these data, we argue that biosimilars approved in the EU are highly similar to and interchangeable with their reference products. Thus, additional systematic switch studies are not ...
Source: Drugs - October 1, 2021 Category: Drugs & Pharmacology Source Type: research

Avalglucosidase alfa: First Approval
This article summarizes the milestones in the development of avalglucosidase alfa leading to this first approval for late-onset Pompe disease. (Source: Drugs)
Source: Drugs - September 30, 2021 Category: Drugs & Pharmacology Source Type: research

Donafenib: First Approval
This article summarizes the milestones in the development of donafenib leading to this first approval for use in unresectable hepatocellular carcinoma. (Source: Drugs)
Source: Drugs - September 30, 2021 Category: Drugs & Pharmacology Source Type: research

Avalglucosidase alfa: First Approval
This article summarizes the milestones in the development of avalglucosidase alfa leading to this first approval for late-onset Pompe disease. (Source: Drugs)
Source: Drugs - September 30, 2021 Category: Drugs & Pharmacology Source Type: research

Donafenib: First Approval
This article summarizes the milestones in the development of donafenib leading to this first approval for use in unresectable hepatocellular carcinoma. (Source: Drugs)
Source: Drugs - September 30, 2021 Category: Drugs & Pharmacology Source Type: research

Targeting the Angiopoietin/Tie Pathway: Prospects for Treatment of Retinal and Respiratory Disorders
AbstractAnti-angiogenic approaches have significantly advanced the treatment of vascular-related pathologies. The ephemeral outcome and known side effects of the current vascular endothelial growth factor (VEGF)-based anti-angiogenic treatments have intensified research on other growth factors. The angiopoietin/Tie (Ang/Tie) family has an established role in vascular physiology and regulates angiogenesis, vascular permeability, and inflammatory responses. The Ang/Tie family consists of angiopoietins 1 –4, their receptors, tie1 and 2 and the vascular endothelial-protein tyrosine phosphatase (VE-PTP). Modulation of Tie...
Source: Drugs - September 29, 2021 Category: Drugs & Pharmacology Source Type: research

REal worlD Effectiveness and Safety of Mepolizumab in a Multicentric Spanish Cohort of Asthma Patients Stratified by Eosinophils: The REDES Study
AbstractBackgroundThe efficacy of mepolizumab is well documented in severe eosinophilic asthma (SEA), although the stringent selection criteria adopted by SEA clinical trials limits the generalizability of results.ObjectiveOur study evaluated the effectiveness and safety of mepolizumab in patients with SEA in Spain. The primary efficacy endpoint was the change in the rate of clinically significant asthma exacerbations 12 months after starting mepolizumab compared to the baseline rate in the 12 months prior to treatment. Patients were stratified by baseline blood eosinophil counts.MethodsWe conducted a multicentric observat...
Source: Drugs - September 29, 2021 Category: Drugs & Pharmacology Source Type: research

Targeting the Angiopoietin/Tie Pathway: Prospects for Treatment of Retinal and Respiratory Disorders
AbstractAnti-angiogenic approaches have significantly advanced the treatment of vascular-related pathologies. The ephemeral outcome and known side effects of the current vascular endothelial growth factor (VEGF)-based anti-angiogenic treatments have intensified research on other growth factors. The angiopoietin/Tie (Ang/Tie) family has an established role in vascular physiology and regulates angiogenesis, vascular permeability, and inflammatory responses. The Ang/Tie family consists of angiopoietins 1 –4, their receptors, tie1 and 2 and the vascular endothelial-protein tyrosine phosphatase (VE-PTP). Modulation of Tie...
Source: Drugs - September 29, 2021 Category: Drugs & Pharmacology Source Type: research

REal worlD Effectiveness and Safety of Mepolizumab in a Multicentric Spanish Cohort of Asthma Patients Stratified by Eosinophils: The REDES Study
AbstractBackgroundThe efficacy of mepolizumab is well documented in severe eosinophilic asthma (SEA), although the stringent selection criteria adopted by SEA clinical trials limits the generalizability of results.ObjectiveOur study evaluated the effectiveness and safety of mepolizumab in patients with SEA in Spain. The primary efficacy endpoint was the change in the rate of clinically significant asthma exacerbations 12 months after starting mepolizumab compared to the baseline rate in the 12 months prior to treatment. Patients were stratified by baseline blood eosinophil counts.MethodsWe conducted a multicentric observat...
Source: Drugs - September 29, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Netupitant/Palonosetron: A Review in Chemotherapy-Induced Nausea and Vomiting
(Source: Drugs)
Source: Drugs - September 24, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Tralokinumab: First Approval
(Source: Drugs)
Source: Drugs - September 24, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Netupitant/Palonosetron: A Review in Chemotherapy-Induced Nausea and Vomiting
(Source: Drugs)
Source: Drugs - September 24, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Tralokinumab: First Approval
(Source: Drugs)
Source: Drugs - September 24, 2021 Category: Drugs & Pharmacology Source Type: research

Anifrolumab: First Approval
This article summarizes the milestones in the development of anifrolumab leading to this first approval for the treatment of moderate to severe SLE. (Source: Drugs)
Source: Drugs - September 23, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Odevixibat: First Approval
(Source: Drugs)
Source: Drugs - September 23, 2021 Category: Drugs & Pharmacology Source Type: research

Anifrolumab: First Approval
This article summarizes the milestones in the development of anifrolumab leading to this first approval for the treatment of moderate to severe SLE. (Source: Drugs)
Source: Drugs - September 23, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Odevixibat: First Approval
(Source: Drugs)
Source: Drugs - September 23, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Tralokinumab: First Approval
(Source: Drugs)
Source: Drugs - September 17, 2021 Category: Drugs & Pharmacology Source Type: research

Furmonertinib: First Approval
This article summarizes the milestones in the development of furmonertinib leading to this first approval forEGFR T790M-positive NSCLC. (Source: Drugs)
Source: Drugs - September 15, 2021 Category: Drugs & Pharmacology Source Type: research

Bone Mineral Density Loss and Fracture Risk After Discontinuation of Anti-osteoporotic Drug Treatment: A Narrative Review
The objective of this narrative review was to describe the effects of discontinuation of anti-osteoporotic drugs and to investigate what is not yet known on this topic. For each anti-osteoporotic agent, PubMed was searched for evidence from randomized clinical trials in patients with osteoporosis on osteoporotic drugs lasting ≥ 3 years, followed by ≥ 1 year of follow-up after discontinuation of therapy and reported at least one item of the following: changes in bone mineral density, bone turnover markers and/or the risk of vertebral and/or nonvertebral fractures after discontinuation of therapy. The% change in bone m...
Source: Drugs - September 15, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Aducanumab: First Approval
(Source: Drugs)
Source: Drugs - September 15, 2021 Category: Drugs & Pharmacology Source Type: research

Furmonertinib: First Approval
This article summarizes the milestones in the development of furmonertinib leading to this first approval forEGFR T790M-positive NSCLC. (Source: Drugs)
Source: Drugs - September 15, 2021 Category: Drugs & Pharmacology Source Type: research

Bone Mineral Density Loss and Fracture Risk After Discontinuation of Anti-osteoporotic Drug Treatment: A Narrative Review
The objective of this narrative review was to describe the effects of discontinuation of anti-osteoporotic drugs and to investigate what is not yet known on this topic. For each anti-osteoporotic agent, PubMed was searched for evidence from randomized clinical trials in patients with osteoporosis on osteoporotic drugs lasting ≥ 3 years, followed by ≥ 1 year of follow-up after discontinuation of therapy and reported at least one item of the following: changes in bone mineral density, bone turnover markers and/or the risk of vertebral and/or nonvertebral fractures after discontinuation of therapy. The% change in bone m...
Source: Drugs - September 15, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Aducanumab: First Approval
(Source: Drugs)
Source: Drugs - September 15, 2021 Category: Drugs & Pharmacology Source Type: research