DiaCarta Inc., a leading molecular diagnostic test developer for cancer and infectious diseases, has announced a strategic partnership with Hopkins MedTech Compliance (HMC) and Hopkins MedTech Lab Services (HML) to address the regulatory compliance and laboratory developed test (LDT) validation needs in the United States. This collaboration aims to provide support to companies that have develope..
PaxMedica, a clinical stage biopharmaceutical company, has announced positive top line results from the PAX-101 Phase 3 African Sleeping Sickness study. The study successfully achieved its primary endpoint and demonstrated statistically significant and clinically meaningful results. These findings are an important step towards filing an NDA for the use of PAX-101 in the treatment of African Slee..
Grifols, a global leader in the production of plasma-derived medicines, has announced positive results from a Phase 4 study investigating the use of XEMBIFY®, its subcutaneous immunoglobulin product, administered every two weeks. The study successfully met its primary objective by demonstrating comparable levels of total immunoglobulins when compared to weekly administration in patients with pri..
23andMe Releases New FDA-Cleared Genetic Report on Simvastatin, a Commonly Prescribed Statin In an exciting development, 23andMe has become the first and only direct-to-consumer product to offer a suite of FDA-authorized pharmacogenetics reports, providing valuable medication insights. One such report focuses on simvastatin, a widely prescribed lipid-lowering statin. Genetics can significantly i..
Hoth Therapeutics, a biopharmaceutical company focused on patient care, has recently received protocol approval for its cancer therapeutic, HT-001. This exciting development was announced on July 19, 2023.   The FDA-approved trial now has two sites approved for conducting the study, and additional sites are currently in the approval process. This means that recruitment of patients can now be..
