Bio-Techne Corporation (NASDAQ: TECH) has announced today that its Molecular Diagnostics Division, Asuragen, has successfully obtained Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX® qPCR BCR-ABL IS Kit. This certification marks a…
Labcorp, a leading provider of cutting-edge laboratory services, has unveiled its latest breakthrough: a test capable of detecting phosphorylated tau 217 (pTau217) in the blood. This innovative biomarker serves as a crucial tool in diagnosing Alzheimer’s disease and monitoring patients…
Merck (NYSE: MRK), also known as MSD outside the United States and Canada, made a significant announcement today at the EUROGIN 2024 HPV Congress. The company revealed its intentions to commence clinical development of a groundbreaking investigational multi-valent HPV vaccine…
The Role of Quality Control at Orion Pharmaceuticals Maija Blomquist, the Quality Control Manager for Materials, Gels & Ointments, underscores the pivotal role of quality control in maintaining Orion’s product standards. Acting as sentinels throughout the production cycle, her team…
Unlocking Project Management’s Role in CDMOs In the intricate web of pharmaceutical and biotech industries, Contract Development and Manufacturing Organizations (CDMOs) stand as pivotal partners, offering indispensable services like API synthesis, formulation, and packaging—essentials for drug manufacturing. Project management emerges…
Amgen Unveils New Research on Otezla® (Apremilast) at AAD 2024 Amgen, a leader in biotechnology, has disclosed fresh findings from the Phase 3 SPROUT trial, investigating Otezla® (apremilast) in children and adolescents aged 6 to 17 with moderate to severe…
Eli Lilly and Company (NYSE: LLY) has disclosed findings from a pioneering investigation into lebrikizumab, tailored specifically for individuals with skin of color grappling with moderate-to-severe atopic dermatitis, commonly known as eczema. The study unveiled that lebrikizumab, an investigational treatment,…
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…