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Brazil issues first license for sale of a cannabis-based drug
Tuesday, January 17, 2017Brazilian healthcare regulator Anvisa on Monday said it had issued the countrys first license for sale of a cannabisbased drug in the country after years of legal wrangling with patients The multiple sclerosis treatment an oral spray derived from ma...
Benitec Biopharma Receives Orphan Drug Designation in the European Union for BB-301
Tuesday, January 17, 2017Benitec Biopharma Limited is pleased to announce that the European Commission based on a favourable recommendation from the European Medicines Agency EMA Committee for Orphan Medicinal Products COMP has granted Orphan Drug Designation to BB as an orp...
U.S. Supreme Court agrees to hear dispute over biologic drug sales
Monday, January 16, 2017The US Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them The justices will take up an appeal by Novartis AG...
Sunovion Announces Pivotal Study Results for Novel Drug Candidate Dasotraline
Monday, January 16, 2017Sunovion Pharmaceuticals Inc Sunovion announced that results of a pivotal Phase study SEP evaluating novel drug candidate dasotraline in children ages to years with attention deficit hyperactivity disorder ADHD showed statistically significant imp...
Lupin launches generic morphine sulfate tablets in US
Saturday, January 14, 2017Pharma major Lupin today said it has launched in the US market its generic version of morphine sulfate ER tablets used for management of severe pain The company said it has launched the morphine sulfate ER Tablets in strengths of mg mg mg mg and...
Shionogi Announces Positive Top-Line Results For Cefiderocol Pivotal cUTI Clinical Trial
Friday, January 13, 2017Shionogi Co Ltd has announced that cefiderocol S a novel siderophore cephalosporin in latestage development met the FDA prespecified primary endpoint for noninferiority vs imipenemcilastatin IPMCS in patients with serious complicated urinary tract i...
Harrington Discovery Institute and Alzheimer's Drug Discovery Foundation Expand Collaboration
Friday, January 13, 2017Harrington Discovery Institute at University Hospitals in Cleveland Ohio and the Alzheimers Drug Discovery Foundation ADDF have expanded their collaboration to accelerate translation of innovative research efforts for Alzheimers disease Together the...
Kitov Pharmaceuticals Enters Immuno-Oncology Field Through Acquisition of TyrNovo
Friday, January 13, 2017Kitov Pharmaceuticals Holdings Ltd an innovative biopharmaceutical company announced the expansion of its pipeline through the acquisition of a majority stake in TyrNovo Ltd a privately held developer of novel small molecules in the immunooncology th...
U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzumab
Thursday, January 12, 2017Mylan NV and Biocon Ltd announced that the US Food and Drug Administration FDA has accepted Mylans biologics license application BLA for MYLO a proposed biosimilar trastuzumab for filing through the k pathway This product is a proposed biosimilar to...
Aralez Pharmaceuticals Announces Issuance Of Additional U.S. Patent For Yosprala
Thursday, January 12, 2017Aralez Pharmaceuticals Inc a global specialty pharmaceutical company announced that the United States Patent and Trademark Office USPTO has issued a patent entitled Compositions and Methods for Delivery of Omeprazole Plus Acetylsalicylic Acid that co...
