Recurrence of non-sexually acquired acute genital ulceration following COVID-19 vaccination
We report a case of non-sexually acquired acute genital ulceration that initially presented in 2008 as Lipschutz labial ulcers associated with acute Epstein-Barr virus infection, with recurrence twelve years later following administration of the second dose of the Pfizer-BioNTech COVID-19 vaccine. This case report and exhaustive literature review challenges widely accepted views regarding the typical age range of patients affected by non-sexually acquired acute genital ulceration, the sexual history of affected populations, the pathophysiology of lesion occurrence, and possibility of lesion recurrence.PMID:38478671 | DOI:1...
Source: Dermatol Online J - March 13, 2024 Category: Dermatology Authors: Christy L Waterman Iris K Aronson Source Type: research

Recurrence of non-sexually acquired acute genital ulceration following COVID-19 vaccination
We report a case of non-sexually acquired acute genital ulceration that initially presented in 2008 as Lipschutz labial ulcers associated with acute Epstein-Barr virus infection, with recurrence twelve years later following administration of the second dose of the Pfizer-BioNTech COVID-19 vaccine. This case report and exhaustive literature review challenges widely accepted views regarding the typical age range of patients affected by non-sexually acquired acute genital ulceration, the sexual history of affected populations, the pathophysiology of lesion occurrence, and possibility of lesion recurrence.PMID:38478671 | DOI:1...
Source: Dermatol Online J - March 13, 2024 Category: Dermatology Authors: Christy L Waterman Iris K Aronson Source Type: research

Recurrence of non-sexually acquired acute genital ulceration following COVID-19 vaccination
We report a case of non-sexually acquired acute genital ulceration that initially presented in 2008 as Lipschutz labial ulcers associated with acute Epstein-Barr virus infection, with recurrence twelve years later following administration of the second dose of the Pfizer-BioNTech COVID-19 vaccine. This case report and exhaustive literature review challenges widely accepted views regarding the typical age range of patients affected by non-sexually acquired acute genital ulceration, the sexual history of affected populations, the pathophysiology of lesion occurrence, and possibility of lesion recurrence.PMID:38478671 | DOI:1...
Source: Dermatol Online J - March 13, 2024 Category: Dermatology Authors: Christy L Waterman Iris K Aronson Source Type: research

Recurrence of non-sexually acquired acute genital ulceration following COVID-19 vaccination
We report a case of non-sexually acquired acute genital ulceration that initially presented in 2008 as Lipschutz labial ulcers associated with acute Epstein-Barr virus infection, with recurrence twelve years later following administration of the second dose of the Pfizer-BioNTech COVID-19 vaccine. This case report and exhaustive literature review challenges widely accepted views regarding the typical age range of patients affected by non-sexually acquired acute genital ulceration, the sexual history of affected populations, the pathophysiology of lesion occurrence, and possibility of lesion recurrence.PMID:38478671 | DOI:1...
Source: Dermatol Online J - March 13, 2024 Category: Dermatology Authors: Christy L Waterman Iris K Aronson Source Type: research

Fidanacogene Elaparvovec: First Approval
This article summarizes the milestones in the development of fidanacogene elaparvovec leading to this first approval for moderately severe to severe (factor IX activity ≤ 2%) haemophilia B who are negative for neutralizing antibodies to AAVRh74var. (Source: Drugs)
Source: Drugs - March 12, 2024 Category: Drugs & Pharmacology Source Type: research

Reversible cerebral vasoconstriction syndrome and posterior reversible encephalopathy syndrome following vaccination: analysis of the VAERS database and systematic review
CONCLUSIONS: This study provides a comprehensive analysis of postvaccine RCVS and PRES. Both disease states were seen most often in those with pre-existing risk factors such as female sex, age over 50, hypertension, renal disease, and immunosuppression. Vaccines and their associated immune response may cause endothelial dysfunction leading to cerebral vasospasm and loss of cerebral autoregulation. However, further research is required to understand the underlying pathophysiological mechanisms. Despite the associations found, the absolute risk of these syndromes remains extremely low compared to the immense benefits of vacc...
Source: Annals of Medicine - March 11, 2024 Category: Internal Medicine Authors: Bahadar S Srichawla Ton Fang Vincent Kipkorir Maria A Garcia-Dominguez Source Type: research

Safety monitoring of bivalent mRNA COVID-19 vaccine among pregnant persons in the vaccine adverse event reporting System - United States, September 1, 2022 - March 31, 2023
CONCLUSIONS: Based on this review of reports to VAERS, the safety profile of bivalent mRNA COVID-19 vaccination in pregnant persons was comparable to that observed for monovalent mRNA COVID-19 booster vaccination (3rd and 4th dose) in pregnant persons.PMID:38462432 | DOI:10.1016/j.vaccine.2024.02.084 (Source: Vaccine)
Source: Vaccine - March 10, 2024 Category: Allergy & Immunology Authors: Pedro L Moro Grace Carlock Nimita Fifadara Tei Habenicht Bicheng Zhang Penelope Strid Paige Marquez Source Type: research

Safety monitoring of bivalent mRNA COVID-19 vaccine among pregnant persons in the vaccine adverse event reporting System - United States, September 1, 2022 - March 31, 2023
CONCLUSIONS: Based on this review of reports to VAERS, the safety profile of bivalent mRNA COVID-19 vaccination in pregnant persons was comparable to that observed for monovalent mRNA COVID-19 booster vaccination (3rd and 4th dose) in pregnant persons.PMID:38462432 | DOI:10.1016/j.vaccine.2024.02.084 (Source: Vaccine)
Source: Vaccine - March 10, 2024 Category: Allergy & Immunology Authors: Pedro L Moro Grace Carlock Nimita Fifadara Tei Habenicht Bicheng Zhang Penelope Strid Paige Marquez Source Type: research

Master protocols and other innovative trial designs in inflammation and immunology to expedite clinical drug development
Drug Discov Today. 2024 Mar 7:103948. doi: 10.1016/j.drudis.2024.103948. Online ahead of print.ABSTRACTMaster protocol designs such as umbrella and basket studies allow multiple compounds or multiple target populations to be evaluated simultaneously within a single protocol, and THEY have been widely adopted in oncology clinical trials. These novel designs can also be applied in other therapeutic areas, where they could have several benefits over conducting traditional randomized controlled trials. Here, we detail Pfizer's recent implementations of master protocol designs in inflammation and immunology clinical studies, fo...
Source: Drug Discovery Today - March 9, 2024 Category: Drugs & Pharmacology Authors: Elena Peeva Anindita Banerjee Christopher Banfield Koshika Soma Jared Christensen Sandeep Menon Michael S Vincent Mikael Dolsten Source Type: research

Master protocols and other innovative trial designs in inflammation and immunology to expedite clinical drug development
Drug Discov Today. 2024 Mar 7:103948. doi: 10.1016/j.drudis.2024.103948. Online ahead of print.ABSTRACTMaster protocol designs such as umbrella and basket studies allow multiple compounds or multiple target populations to be evaluated simultaneously within a single protocol, and THEY have been widely adopted in oncology clinical trials. These novel designs can also be applied in other therapeutic areas, where they could have several benefits over conducting traditional randomized controlled trials. Here, we detail Pfizer's recent implementations of master protocol designs in inflammation and immunology clinical studies, fo...
Source: Drug Discovery Today - March 9, 2024 Category: Drugs & Pharmacology Authors: Elena Peeva Anindita Banerjee Christopher Banfield Koshika Soma Jared Christensen Sandeep Menon Michael S Vincent Mikael Dolsten Source Type: research

Master protocols and other innovative trial designs in inflammation and immunology to expedite clinical drug development
Drug Discov Today. 2024 Mar 7:103948. doi: 10.1016/j.drudis.2024.103948. Online ahead of print.ABSTRACTMaster protocol designs such as umbrella and basket studies allow multiple compounds or multiple target populations to be evaluated simultaneously within a single protocol, and THEY have been widely adopted in oncology clinical trials. These novel designs can also be applied in other therapeutic areas, where they could have several benefits over conducting traditional randomized controlled trials. Here, we detail Pfizer's recent implementations of master protocol designs in inflammation and immunology clinical studies, fo...
Source: Drug Discovery Today - March 9, 2024 Category: Drugs & Pharmacology Authors: Elena Peeva Anindita Banerjee Christopher Banfield Koshika Soma Jared Christensen Sandeep Menon Michael S Vincent Mikael Dolsten Source Type: research

Master protocols and other innovative trial designs in inflammation and immunology to expedite clinical drug development
Drug Discov Today. 2024 Mar 7:103948. doi: 10.1016/j.drudis.2024.103948. Online ahead of print.ABSTRACTMaster protocol designs such as umbrella and basket studies allow multiple compounds or multiple target populations to be evaluated simultaneously within a single protocol, and THEY have been widely adopted in oncology clinical trials. These novel designs can also be applied in other therapeutic areas, where they could have several benefits over conducting traditional randomized controlled trials. Here, we detail Pfizer's recent implementations of master protocol designs in inflammation and immunology clinical studies, fo...
Source: Drug Discovery Today - March 9, 2024 Category: Drugs & Pharmacology Authors: Elena Peeva Anindita Banerjee Christopher Banfield Koshika Soma Jared Christensen Sandeep Menon Michael S Vincent Mikael Dolsten Source Type: research

Master protocols and other innovative trial designs in inflammation and immunology to expedite clinical drug development
Drug Discov Today. 2024 Mar 7:103948. doi: 10.1016/j.drudis.2024.103948. Online ahead of print.ABSTRACTMaster protocol designs such as umbrella and basket studies allow multiple compounds or multiple target populations to be evaluated simultaneously within a single protocol, and THEY have been widely adopted in oncology clinical trials. These novel designs can also be applied in other therapeutic areas, where they could have several benefits over conducting traditional randomized controlled trials. Here, we detail Pfizer's recent implementations of master protocol designs in inflammation and immunology clinical studies, fo...
Source: Drug Discovery Today - March 9, 2024 Category: Drugs & Pharmacology Authors: Elena Peeva Anindita Banerjee Christopher Banfield Koshika Soma Jared Christensen Sandeep Menon Michael S Vincent Mikael Dolsten Source Type: research