MRM Health, a clinical-stage biopharmaceutical firm, has obtained regulatory and ethics committee approval to commence an observational, cross-sectional clinical trial examining the role of the small intestinal microbiome in Parkinson’s Disease (PD). This trial aims to identify PD-specific microbial and…
Approximately 80% of the global population faces the threat of contracting one or more vector-borne diseases, with mosquitoes, flies, bugs, and other vectors transmitting viruses, parasites, and bacteria to millions worldwide. These diseases, including malaria, dengue, Chikungunya, yellow fever, Zika…
In the AdFirst trial, Biotest’s fibrinogen concentrate (FC), BT524, successfully met the primary endpoint, demonstrating its efficacy in treating acquired fibrinogen deficiency (AFD) on par with standard care, while maintaining an outstanding safety record. Regulatory approval processes in both Europe…
ResearchAndMarkets.com is pleased to announce the addition of “FDA Inspection” training to its offerings. This two-day seminar is meticulously crafted to equip professionals in the pharmaceutical, biopharmaceutical, biologics, and medical device industries with the essential knowledge and tools to adeptly…
CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company dedicated to pioneering gene-based treatments for severe illnesses, disclosed today that the European Commission has granted conditional marketing authorization for CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy. CASGEVY has been cleared for…
Results from the latest analyses of bimekizumab phase 3 trials in patients with moderate to severe hidradenitis suppurativa (HS) will be presented at the 13th Conference of the European Hidradenitis Suppurativa Foundation (EHSF) in Lyon, France (February 7-9, 2024). UCB,…
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Novartis Pharma K.K. (Novartis Pharma) has received approval for an expanded treatment indication of pediatric chronic heart failure for Entresto® Tablets, an angiotensin receptor neprilysin inhibitor (ARNI) available in 50 mg, 100 mg,…
BioNTech SE (Nasdaq: BNTX, “BioNTech”), a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, and Autolus Therapeutics plc (Nasdaq: AUTL, “Autolus”), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced a strategic collaboration aimed at advancing…
At an upcoming presentation at the RSVVW’24 conference, Moderna will share follow-up data from its ongoing ConquerRSV Phase 3 study of its investigational RSV vaccine candidate, mRNA-1345. As previously published in the New England Journal of Medicine, the primary analysis from…
Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE PFE) have announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tisotumab vedotin, an antibody-drug conjugate (ADC), intended for the treatment of adult patients with recurrent…
Bio-Techne Corporation (NASDAQ: TECH) has unveiled a groundbreaking achievement, as its spatial biology brand, Advanced Cell Diagnostics (ACD), sets a new industry standard. The innovation comes in the form of a cutting-edge, protease-free RNAscope spatial multiomics workflow, designed for superior…
Vivet Therapeutics Secures EUR 4.9 Million Government Funding for Gene Therapy Advancement in Cerebrotendinous Xanthomatosis Treatment” Vivet Therapeutics, a biotech company specializing in gene therapies for rare inherited metabolic disorders, has received EUR 4.9 million in funding from the French…