Category - Developments

Developments

FDA releases Theratechnologies from EGRIFTA post-approval commitments

The FDA has released Theratechnologies (TSX:TH) from post-approval commitments related to the approval of EGRIFTA. When the FDA approved EGRIFTA in 2010, the agency requested that the company conduct two large safety...

May 1, 2018

Developments

Saniona moving to second part of Phase 2a study in Prader-Willi Syndrome

Closely-held Saniona of Denmark has obtained approval to initiate the second part of its Phase 2a trial for Tesomet in adolescents with Prader-Willi syndrome (PWS), the most common genetic cause of life-threatening...

April 26, 2018

Developments

Adocia and Tonghua Dongbao in insulin strategic alliance in China

Adocia (Euronext Paris:FR0011184241 – ADOC) and Tonghua Dongbao Pharmaceuticals (Shanghai Stock Exchange 600867) announced a strategic partnership, giving Tonghua exclusive development and commercialization rights in...

April 26, 2018

Developments

Theratechnologies to seek approval of Trogarzo in Europe

Theratechnologies (TSX:TH) plans to seek regulatory approval from the European Medicines Agency (EMA) for Trogarzo using efficacy and safety data from clinical trials submitted to the FDA. “Based on our discussions, we...

April 24, 2018

Developments

CellAegis inks first distribution deal for autoRIC in Europe

Closely-held CellAegis Devices entered into a definitive agreement with Cardiologic, for the marketing and distribution of its autoRIC device in the UK and Ireland. “This marks the first distribution agreement for the...

April 24, 2018

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

Category - Developments

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