Janssen’s Invokana became the only medicine in nearly 20 years and the first diabetes medicine ever to demonstrate a reduction in progression to end-stage renal failure in T2D patients with CKD.
J&J agreed to develop and market Arrowhead Pharmaceuticals Inc.’s gene-silencing hepatitis B treatment and buy a minor stake in a deal that could be potentially worth more than $3.7 billion.
The U.S. FDA approved Novo Nordisk A/S’ diabetes drug Ozempic, setting the stage for a heated battle with Eli Lilly & Co.’s Trulicity.
Nine Biotechs Facing FDA Decisions in December 2017Active Psoriatic Arthritis (PsA), Biopharma, Biosimilars, Biotech, Breast Cancer, Chronic Myeloid Leukemia (CML), Contraceptives, FDA, FDA/Regulatory, Glucagon-Like Peptide-1 (GLP-1) Analogs, Growth Hormone Deficiency (GHD), Hormonal Contraceptive Patches, New Drug Application (NDA), New Drug Applications, OTC, Patches, PDUFA, Supplemental Biologics License Application (sBLA), Supplemental New Drug Application (sNDA), Supplemental New Drug Application (sNDA), Type 2 Diabetes
The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.
Sumitomo Dainippon Pharma Co. Ltd. and Poxel SA announced the signing of a strategic partnership for the development and commercialization of Imeglimin – an investigational therapeutic agent for type 2 diabetes – in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. Poxel is a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders.
Ionis Pharmaceuticals Inc. said its rare metabolic disorder drug for severe hypertriglyceridemia met the main goal in a late-stage study.
Horizon Pharma ended a late-stage trial that was testing Actimmune as a treatment for a rare neuromuscular disorder that has no approved medicines.
Incentives, Opportunities Abound as Orphan Drug Demand GrowsBiopharma, Bones, Breakthrough Therapy Designation, CDC, Congress, Department of Health and Human Services (HHS), EMA, Enzyme Replacement, EU, FDA, FDA/Regulatory, glioblastoma Multiforme (GBM) Brain Cancer, Hypophosphatasia (HPP), June 2017, Metabolic Disorders, Orphan Drug Act, Rare Diseases
Concerted effort by governments, regulators, and industry is rapidly expanding development of new therapies for the more than 7,000 known rare diseases.
Gilead Sciences struck a $1.2 billion deal to acquire Cambridge, Mass.-based Nimbus Apollo Inc. for its Acetyl-CoA Carboxylase (ACC) inhibitor program.
A new drug to treat a rare inherited bone disorder from Alexion Pharmaceuticals ALXN.O that costs more than $550,000 a year for each patient has been deemed too expensive by […]