Company Product Description Indication Status
Amarin Corp. plc, of Dublin Vascepa (icosapent ethyl) Fish oil Elevated triglyceride levels FDA approved label expansion to include reduction of the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization
Arrowhead Pharmaceuticals Inc., of Pasadena, Calif. ARO-HSD RNAi Nonalcoholic steatohepatitis (NASH) Filed application to start the phase I AROHSD1001 study in healthy volunteers and patients with NASH or suspected NASH
Avadel Pharmaceuticals plc, of Dublin Nouress (AV-001) Cysteine hydrochloride injection Neonatal patients requiring total parenteral nutrition FDA approved the marketing application
Diurnal Group plc, of London Chronocort Modified release hydrocortisone Congenital adrenal hyperplasia Submitted MAA to the EMA
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J. Ryanodex (dantrolene sodium) Ryanodine receptor 1 antagonist Organophosphate exposure FDA granted orphan drug designation
Epizyme Inc., of Cambridge, Mass. Tazemetostat EZH2 inhibitor Epithelioid sarcoma FDA posted documents ahead of Oncologic Drugs Advisory Committee meeting on 12/18
Kura Oncology Inc., of San Diego Tipifarnib Protein farnesyltransferase inhibitor Squamous cell carcinoma Gained FDA fast track designation for the treatment of patients with HRAS-mutant head and neck squamous cell carcinomas after progression on platinum therapy
Merck & Co. Inc. Recarbrio (imipenem + relebactam + cilastatin) Dehydropeptidase-1 inhibitor; Beta lactamase inhibitor Gram-negative bacterium infection EMA's CHMP adopted a positive opinion recommending the combination antibacterial agent for approval
Mirum Pharmaceuticals Inc., of Foster City, Calif. Maralixibat  Inhibitor of apical sodium codependent bile acid transporter Alagille syndrome Completed pre-NDA meetings with FDA for maralixibat for the treatment of pruritus associated with Alagille syndrome; planning rolling NDA submission in Q3 2020
Orthocell Ltd., of Perth, Australia Celgro Regenerative medicine Nerve repair FDA confirmed Celgro nerve regeneration study design meets US 510(k) submission requirements; preclinical study to begin in Q1 2020
Salarius Pharmaceuticals Inc., of Houston Seclidemstat Lysine specific histone demethylase 1 inhibitor Ewing sarcoma Granted fast track designation by the FDA for the treatment of patients with Ewing sarcoma who have relapsed or are refractory to standard-of-care therapy

Notes

For more information about individual companies and/or products, see Cortellis.

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