Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation

Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH). PAH affects hundreds of thousands in the U.S. and globally and is resulting from changes in cells that causes damages […]

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21 ธ.ค. 63

Small vessels can cause big problems; MagicTouch SCB Granted ‘Breakthrough Device Designation’ for the treatment of Small Coronary Artery Lesions

Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed indication for use includes “The MagicTouch SCB Sirolimus Coated Balloon Catheter […]

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18 ธ.ค. 63

RedHill’s Phase 2/3 COVID-19 Candidate Opaganib Reduces ARDS-Related Blood Clotting in Preclinical Model

Acute respiratory distress syndrome (ARDS)-induced thrombosis (blood clotting) may occur in up to one-third of COVID-19 patients requiring ICU admission and is a contributing cause of mortality Opaganib demonstrated reduced thrombosis in a preclinical model of ARDS Opaganib has also been shown to inhibit SARS-CoV-2 viral replication as well as pro-inflammatory markers in relevant preclinical […]

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18 ธ.ค. 63

ADC Therapeutics and Overland Pharma Form Strategic JV to Expand ADC Drugs Development and commercialization in Greater China and Singapore, Advised by MSQ Ventures

M.S.Q. Ventures (“MSQ”) is pleased to announce that its client, ADC Therapeutics SA (NYSE: ADCT), has successfully entered into an agreement to jointly form a new company, Overland ADCT BioPharma (CY) Limited with Overland Pharmaceuticals, a fully integrated, biopharmaceutical company backed by Hillhouse Capital. Under the terms of the agreement, ADC Therapeutics licensed exclusive development […]

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16 ธ.ค. 63
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