Pharmaceuticals, Biotechnology and Life Sciences
U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Active Biotech for its investigational novel agent tasquinimod, for the treatment of multiple myeloma.
The U.S. Food and Drug Administration has approved Neurocrine Biosciences’s Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia.
Diplomat Pharmacy has appointed Atul Kavthekar as chief financial officer and treasurer, effective May 1, 2017.
Bristol-Myers Squibb and Apexigen, a clinical-stage biopharmaceutical company focused on discovering and developing antibody-based therapeutics for the treatment of cancer, have started a clinical trial collaboration to evaluate Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Apexigen’s APX005M in patients with advanced solid tumors.
U.S. Food and Drug Administration (FDA) has set a PDUFA date of September 8, 2017 for its decision on the New Drug Application (NDA) for Nicox’s Zerviate (cetirizine ophthalmic solution) 0.24%.
Johnson & Johnson’s company Codman Neuro has acquired Neuravi Limited, a company dedicated to advancing neurovascular therapies and improving clinical outcomes for acute ischemic stroke patients.
U.S. Food and Drug Administration (FDA) has approved supplemental indications for Gilead Sciences’s Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg.
There are few drugs available for the treatment of the disease, and those currently available have generally poor tolerability. As a result, CTCL patients and their physicians require safe and effective new treatment options, said Dr Richard Bethell, Medivir’s Chief Scientific Officer.
Novartis said Thursday it has exercised an option to in-license ECF843 for ophthalmic indications worldwide excepot of Europe, without revealing financial and other terms of this transaction.
Zavante Therapeutics’ investigational product candidate, Zolyd (fosfomycin for injection, also known as ZTI-01), met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam.