BioSpace News Archive

Kenox Pharmaceuticals Inc has submitted Type B Pre-Investigational New Drug (IND) meeting request with the U.S. Food and Drug Administration (FDA) for its lead program KNX018.

AML Biomarker Identification Can Improve Clinical Trials for New Drugs and Accelerate Drug Approvals.

Myrtelle Inc. today announced that earlier this year it entered into an exclusive worldwide licensing agreement with Pfizer Inc. for an investigational recombinant adenovirus (rAAV) gene therapy to bring potential new medicine to patients with Canavan disease (CD), a fatal childhood genetic neurological disorder characterized by the degeneration of the white matter in the brain.

The Infectious Disease Research Institute (IDRI), a Seattle-based non-profit biotech research institute, announced today a contract with the Biomedical Advanced Research and Development Authority (BARDA) DRIVe (Division of Research, Innovation, and Ventures) “Beyond the Needle” program to develop an intranasally delivered RNA vaccine for pandemic influenza.

Moderna, a biotechnology company pioneering messenger RNA therapeutics and vaccines, announced that the Ministry of Food and Drug Safety of Korea has issued a marketing authorization for Spikevax®, Moderna’s COVID-19 vaccine manufactured by Samsung Biologics, a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services.

POXEL SA, a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis and rare disorders, announced its participation at upcoming investor and scientific conferences in January 2022.

Royal Philips, a global leader in health technology, announced that it has signed an agreement to acquire Vesper Medical Inc., a US-based medical technology company that develops minimally-invasive peripheral vascular devices.

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for XELJANZ® / XELJANZ® XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

Idera Pharmaceuticals, Inc. announced clinical updates regarding tilsotolimod, its synthetic Toll-like receptor 9 agonist.

Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced an updated strategy for AT-527 to address the rapidly evolving SARS-CoV-2 and emerging variants by maximizing the compound’s unique profile for potential use as both a monotherapy and in combination.