Oragenics, Inc. (NYSE American: OGEN), a company dedicated to developing innovative intranasal pharmaceuticals for neurological disorders, has revealed its readiness to embark on the final stages of GMP manufacturing and formulation for its drug candidate, ahead of the anticipated Phase…
AbbVie Inc. (NYSE: ABBV) and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage immunotherapy company, have announced a strategic partnership aimed at developing OSE-230, a monoclonal antibody designed to address chronic and severe inflammation. Currently in the pre-clinical development…
The U.S. Food and Drug Administration (FDA) has given priority review status to the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab), marking its sixth potential indication. This review targets its use as an add-on maintenance treatment for specific adult…
AstraZeneca Completes Acquisition of Gracell Biotechnologies Inc., Expanding Cell Therapy Portfolio AstraZeneca has successfully finalized the acquisition of Gracell Biotechnologies Inc. (Gracell, NASDAQ: GRCL), a prominent global biopharmaceutical company specializing in innovative cell therapies for cancer and autoimmune diseases. This…
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…