With another set of positive, top-line phase III results for its pain drug BEMA (bioerodible mucoadhesive) buprenorphine, this time for back pain in opioid-experienced patients, Biodelivery Sciences International Inc.'s (BDSI) partner Endo Pharmaceuticals Inc. plans a sit-down with the FDA later this month to talk about a new drug application (NDA). Read More
LONDON – The UK is making headway with its ambition of becoming a world leader in the clinical application of genomics and personalized medicine, launching a competition for teaching hospitals to set up specialist Genomic Medicines Centers. Read More
LONDON – After five years in operation, Europe's Advanced Therapy Medicinal Products (ATMP) regulation, covering therapies based on genes, cells or tissues, is up for review. Read More
The notion of a broad-spectrum T cell may, at first blush, sound like an oxymoron. The T and B cells of the adaptive immune system are, after all, best known for their exquisite specificity. Read More
Mark Surber, president and CEO of Genoa Pharmaceuticals Inc., has witnessed firsthand the devastation wrought by idiopathic pulmonary fibrosis (IPF), a lung disease linked both to genetic and environmental factors that results in progressive lung scarring. Read More
The recent outbreak of Middle Eastern respiratory syndrome (MERS) has drawn attention once again to the need for new vaccines, an area that offers significant opportunity for biopharma firms. Read More
Genocea Biosciences Inc., of Cambridge, Mass., filed an S-1 with the SEC seeking to raise $69 million through an underwritten public offering. Read More
Acelrx Pharmaceuticals Inc., of Redwood City, Calif., said partner Grunenthal Group, of Aachen, Germany, submitted a marketing authorization application (MAA) to the EMA for Acelrx's Zalviso, a drug-device combination for the management of moderate to severe acute pain in adult patients in a medically supervised environment. Read More
Cardio3 Biosciences SA, of Mont-Saint-Guibert, Belgium, said it has enrolled the 120th patient in its phase III study (CHART-1), aimed at evaluating the potential of product candidate C-Cure for the treatment of heart failure. Read More
Nippon Kayaku Co. Ltd., of Tokyo, said it obtained marketing approval of an infliximab biosimilar that it developed jointly with Celltrion Inc., of Incheon, South Korea. Read More
