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Entries posted by pharmanewsdaily
Cutera truSculpt iD body sculpting treatment gets expanded approval in Canada

Cutera truSculpt iD body sculpting treatment gets expanded approval in Canada

Cutera said that Health Canada has expanded approval for its truSculpt iD body sculpting treatment to cover its use for the reduction of circumference of the abdomen and non-invasive lipolysis, which is the permanent removal of fat cells from the body. According to American Society for Aesthetic Plastic Surgery and Medical Insight (MII), noninvasive body sculpting […]

Genentech bags Rozlytrek FDA approval for two rare types of cancer

Rozlytrek FDA approval : Roche’s subsidiary Genentech has bagged approvals for Rozlytrek (entrectinib) from the US Food and Drug Administration (FDA) for a type of non-small cell lung cancer (NSCLC) and for certain forms of solid tumors. The first Rozlytrek FDA approval is for the treatment of ROS1-positive, metastatic NSCLC in adult patients. Additionally, Rozlytrek […]

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GSK bags Nucala FDA approval for severe eosinophilic asthma in 6-11 years age group

Nucala FDA approval : GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for Nucala (mepolizumab) for the treatment of severe eosinophilic asthma in children, aged six years and older. Nucala, which is a monoclonal antibody that targets IL-5, is now the only targeted biologic to be approved by the FDA […]

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Gemini Therapeutics appoints Jason Meyenburg as CEO

US precision medicine company Gemini Therapeutics, which is focused on developing treatments for age-related macular degeneration (AMD) and linked ocular disorders, has appointed Jason Meyenburg as its Chief Executive Officer (CEO). Jason Meyenburg will also join the Board of Directors of Gemini Therapeutics. Stephen Squinto – Gemini Therapeutics Board Director said: “We are thrilled to have […]

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Castle Creek to acquire cell and gene therapy company Fibrocell

Castle Creek acquisition of Fibrocell : Castle Creek Pharmaceutical Holdings (CCP Holdings) has agreed to acquire Fibrocell Science, a cell and gene therapy company engaged in developing autologous cell-based therapies for skin and connective tissue disorders. Financial terms of the deal were not disclosed, as per the latest pharma industry news. CCP Holdings is a […]

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FeDeriCa clinical trial results : Phase 3 trial in HER2-positive breast cancer meets primary endpoint

FeDeriCa clinical trial results : Roche’s Genentech reported that the phase 3 FeDeriCa study evaluating the investigational fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase in HER2-positive breast cancer met its primary endpoint. The Perjeta and Herceptin combination, which was subcutaneously injected in combination with intravenous (IV) chemotherapy, showed non-inferior levels of […]

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Eisai, Biogen to scrap elenbecestat phase 3 studies in early AD

Eisai and Biogen have decided to stop the MISSION AD1 and AD2 phase 3 clinical studies on elenbecestat in early Alzheimer’s disease (AD) owing to safety concerns, as per the latest clinical trial news. The decision has been driven by the findings of a safety review undertaken by the Data Safety Monitoring Board (DSMB), which […]

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CANDOR clinical trial results : Amgen’s Kyprolis extends PFS in multiple myeloma patients

CANDOR clinical trial results : Amgen said that a phase 3 study assessing Kyprolis (carfilzomib) in combination with dexamethasone and Johnson & Johnson’s Darzalex (daratumumab) (KdD) compared to Kyprolis and dexamethasone alone (Kd), called CANDOR, met its primary endpoint of progression-free survival (PFS) in multiple myeloma patients. The Amgen clinical trial featured 466 relapsed or […]

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RESTORE clinical trial of STR001 : Strekin completes patient enrollment

RESTORE clinical trial of STR001 : Swiss biopharma company Strekin has wrapped up patient enrollment in a phase 3 study, called RESTORE, for evaluating its small molecule STR001 in patients after a sudden sensorineural hearing loss (SSNHL) event. The late-stage trial is a global, randomized, placebo-controlled study, which will feature 165 patients at nearly 25 […]

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CroíValve set to advance Tricuspid Coaptation Valve into clinical trial

CroíValve, an Irish medtech company spun out from Trinity College, has raised €4 million for developing a medical device called Tricuspid Coaptation Valve for the treatment of tricuspid regurgitation (TR), a severe heart condition. The financing secured by the Irish medtech firm includes €2.5 million from the European Union under its Horizon 2020 SME Instrument […]

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