Results 91 to 100 of about 117,653 (216)

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF‐07261271 in healthy participants

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim There is an unmet need for more effective therapies in inflammatory bowel disease (IBD). A single drug that blocks multiple distinct pathogenic pathways may offer therapeutic benefit superior to current monotherapies. PF‐07261271, a bispecific antibody targeting both the p40 subunit of interleukin‐12/23 and tumour necrosis factor‐like cytokine 1A ...
Srividya Neelakantan   +11 more
wiley   +1 more source

Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim This study aimed to compare how Norwegian healthcare professionals (HCPs) and consumers reported the same adverse event (AE) following immunization with vaccines against COVID‐19 during the COVID‐19 pandemic. Specifically, we aimed to compare the extent to which HCPs and consumers reported information relevant for assessing the causal relationship ...
Tommy Emil Dzus   +4 more
wiley   +1 more source

Comparative Safety and Efficacy of Commercial Porcine Vaccines Against Mycoplasma hyopneumoniae and Porcine Circovirus Type 2 (PCV2)

open access: yesAnimals
Mycoplasma hyopneumoniae (Mhyo) and porcine circovirus type 2 (PCV2) infections cause enormous economic losses in the swine production sector. Vaccination remains the most effective strategy against the complex clinical entities caused by these pathogens.
Meritxell Simon-Grifé   +9 more
doaj   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm   +2 more
wiley   +1 more source

What Makes an “Ideal” Cell Line for Recombinant Adeno‐Associated Virus Production?

open access: yesBiotechnology and Bioengineering, EarlyView.
Several host cell types have been used to produce rAAVs to date. Cell line‐specific traits that are beneficial in the context of rAAV manufacturing are reviewed here, with the goal of developing a consensus on the ‘ideal’ characteristics that an rAAV production host should possess (created with Biorender.com).
James Conheady   +6 more
wiley   +1 more source

Glycoengineered Recombinant Alpha1‐Antitrypsin Results in Comparable In Vitro and In Vivo Activities to Human Plasma‐Derived Protein

open access: yesBiotechnology and Bioengineering, EarlyView.
ABSTRACT Alpha‐1‐antitrypsin (A1AT) is a multifunctional, clinically important, high‐value therapeutic glycoprotein that can be used for the treatment of many diseases, such as A1AT deficiency, diabetes, graft‐versus‐host disease, cystic fibrosis, and various viral infections. Currently, the only U.S. food and drug administration‐approved treatment for
Frances Rocamora   +12 more
wiley   +1 more source

Identification of Leptospiral Protein Antigens Recognized by WC1+ γδ T Cell Subsets as Target for Development of Recombinant Vaccines. [PDF]

open access: yesInfect Immun, 2022
Teixeira AF   +6 more
europepmc   +1 more source

Enhancing the Secretion Systems: Genetic Engineering of Super Bioagents for Effective Plant Disease Control

open access: yesBiotechnology and Bioengineering, EarlyView.
Genetic engineering (GE) overcomes BCA limits, enabling robust, scalable crop protection. “Super Bioagents” (SBs) use optimized SSs to enhance bioactive molecule delivery. Optimizing SSs enhance precise, sustainable effector deployment for stable disease suppression. SBs use microbiome‐informed design for scalable, next‐gen sustainable crop protection.
Michael Dare Asemoloye
wiley   +1 more source

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