April 12, 2017
FDA OKs Neurocrine Biosciences’s neurological disorder drug
The U.S. Food and Drug Administration has approved Neurocrine Biosciences’s Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia.
Pharmaceuticals, Biotechnology and Life Sciences
Category: North America
April 11, 2017
Diplomat welcomes new CFO
Diplomat Pharmacy has appointed Atul Kavthekar as chief financial officer and treasurer, effective May 1, 2017.
April 11, 2017
BMS, Apexigen team up to test combination of their cancer drugs
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.
April 11, 2017
Nicox announces PDUFA date for Zerviate NDA
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%.
April 11, 2017
J&J’s subsidiary Codman Neuro buys Irish’s Neuravi Limited
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.
April 7, 2017
FDA OK’s Gilead Sciences’s hepatitis C drug for pediatric 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.
April 7, 2017
Medivir aims $900 million US market with a certain skin cancer treatment
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.
April 6, 2017
Novartis in-licenses dry eye therapeutic ECF843 worldwide
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.
April 6, 2017
Zavante Therapeutics’ Zolyd met goal in a study for treating urinary tract infections
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.
April 6, 2017
Hikma, Jazz settle for Xyrem patent litigation
Hikma Pharmaceuticals and Jazz Pharmaceuticals have found a mutual language regarding a Jazz’s Xyrem patent litigation.