TOKYO and NEW YORK — Astellas Pharma Inc. President and CEO Naoki Okamura and Pfizer Inc. today announced that on December 15 the U.S. Food and Drug Administration (FDA) approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate) with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally...
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WAYNE, Pa. — Palvella Therapeutics Inc., a clinical-stage biopharmaceutical company developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, and Ligand Pharmaceuticals Inc. (Nasdaq: LGND), a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value...
Wayne, Pa. — Palvella Therapeutics, Inc., a late clinical-stage biopharmaceutical company whose vision is to become the leading rare disease company focused on developing and commercializing novel therapies to treat individuals suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, announced positive topline results from...
MINNEAPOLIS — Panbela Therapeutics, Inc., a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs announces the publication of clinical data from studies of CPP-1X (also known as α-Difluoromethylornithine (DFMO) or Eflornithine) in neuroblastoma. According to Hogarty et al, children with relapsed...
MADISON, Wisconsin — Many pancreatic tumors are like malignant fortresses, surrounded by a dense matrix of collagen and other tissue that shields them from immune cells and immunotherapies that have been effective in treating other cancers. Employing bacteria to infiltrate that cancerous fortification and deliver these drugs could aid treatment...
At the end of 2011, I experienced an acute episode of diarrhea and vomiting for hours. I had returned home from New York City, consuming pasta with bacon bits and drinking a few glasses of red wine. By morning, I seemed better and went about my day caring for family, failing to visit a...
Houston, TX – The use of high-protease pancreatic replacement therapy demonstrated improvement in maladaptive behaviors, such as irritability, in preschool children with autism spectrum disorder (ASD), according to research conducted at 32 clinical sites, including UTHealth Houston. The study was published recently in JAMA Network Open. “Children who have ASD...
PITTSBURGH, PA — PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce it was selected by Chiesi Global Rare Diseases, a business unit of the Chiesi Group, for the distribution of Filsuvez® topical gel, the first approved treatment for...
CHICAGO – Emalex Biosciences, Inc. (“Emalex”), a biopharmaceutical company founded by Paragon Biosciences to develop treatments for central nervous system movement disorders and fluency disorders, today announced positive topline results from its Phase 2b clinical study (D1AMOND Study) evaluating the efficacy and safety of ecopipam (EBS-101), an investigational, first-in-class, dopamine-1 (D1) receptor...
CAMBRIDGE, Mass. – Paragonix Technologies, Inc. is announcing the release of the recently developed Paragonix Web Portal, an accessible support platform that connects with the Paragonix App and donor organ preservation devices to provide transplant teams the ability to digitally participate in live sessions or review historical cases and clinical...