Category - Developments

Developments

Oramed starts 90-day pivotal dose-ranging study for oral insulin

Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) has begun screening patients in its 90-day dose-ranging pivotal Phase 2b HbA1c clinical study of its oral insulin capsule, ORMD-0801. A statistically significant improvement in...

April 23, 2018

Developments

Titan Pharma’s Probuphine implant for long-term maintenance treatment of opioid dependence approved by Health Canada

Health Canada has approved the sale of Probuphine, a subdermal implant developed by Titan Pharmaceuticals (NASDAQ:TTNP), for the management of opioid dependence in patients clinically stabilized on no more than 8 mg of...

April 20, 2018

Developments

FDA committee approves GW Pharma cannabidiol for seizures

The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA unanimously recommended supporting the approval of the NDA from GW Pharmaceuticals (NASDAQ:GWPH) and its U.S. subsidiary Greenwich...

April 19, 2018

Developments

FDA approves Angel Medical implantable cardiac monitor

Closely-held Angel Medical Systems has received FDA premarket approval for the AngelMed Guardian System, an implantable cardiac monitor with patient alerting capability and an additional external alarm device. The...

April 18, 2018

Developments

Novocure posts positive mesothelioma data; to file for FDA exemption

Novocure (NASDAQ:NVCR) reported positive top-line results from its STELLAR Phase 2 pilot trial in mesothelioma. The data demonstrate clinically meaningful improvements in overall survival and progression free survival...

April 17, 2018

Developments

Eiger BioPharma presents additional lonafarnib data in HDV

Eiger BioPharmaceuticals (NASDAQ:EIGR) presented additional positive lonafarnib (LNF) data from the LOWR hepatitis delta virus (HDV) program at the International Liver Congress 2018 in Paris. A sub-analysis of the LOWR...

April 17, 2018

Developments

Profound Medical Q2 Top Pick at Paradigm Capital

Paradigm Capital has made Profound Medical (TSXV:PRN; OTCQX:PRFMF) its second quarter Top Pick, saying the next three-to-four months are expected to be an accretive time for Profound. Analyst Rahul Sarugaser writes that...

April 12, 2018

Developments

CymaBay reports positive seladelpar data in PBC

CymaBay Therapeutics (NASDAQ:CBAY) presented new data from a second interim analysis of its ongoing Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC), a type of liver disease that damages...

April 11, 2018

Developments

Arbutus and Roivant launch Genevant Sciences to develop RNA therapeutics

Arbutus Biopharma (NASDAQ:ABUS) and closely-held Roivant Sciences of Switzerland agreed to launch Genevant Sciences, a jointly-owned company focused on the discovery, development, and commercialization of a broad range...

April 11, 2018

Developments

BiondVax begins NIH-sponsored universal flu vaccine trial

BiondVax Pharmaceuticals (NASDAQ:BVXV) enrolled the first participant in a U.S. Phase 2 clinical trial of its universal flu vaccine candidate, M-001. The trial is sponsored by the U.S. National Institute of Allergy and...

April 11, 2018

Category - Developments

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