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Seattle Genetics gets approval of TUKYSA in Switzerland for metastatic HER2-positive breast cancer

May 13, 2020
Seattle Genetics, Inc. announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for TUKYSA (tucatinib) tablets in combination with trastuzumab and…
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Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

May 13, 2020
Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s mRNA vaccine candidate (mRNA-1273) against the novel…
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Sarclisa (isatuximab) Phase 3 IKEMA trial meets primary endpoint early in patients with relapsed…

May 13, 2020
The Phase 3 IKEMA clinical trial evaluating Sarclisa (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis, demonstrating…
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Challenges in a Remote Workforce – Outsourcing in Clinical Trials – A Virtual Experience

May 13, 2020
London – On Wednesday, 27th May, OCT Virtual (https://arena-international.com/octvirtual/) will delve into challenges the clinical trials community is facing as the disruption from…
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Ocular Therapeutix Announces First Patient Dosed in Phase 1 Clinical Trial of OTX-CSI for the…

May 12, 2020
Ocular Therapeutix, Inc. announced that it has dosed the first patients in its Phase 1 clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye…
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Bellerophon Therapeutics Announces FDA Clears Initiation of Phase 3 Study for INOpulse Inhaled…

May 12, 2020
Bellerophon Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application, allowing the Company to initiate a…
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Themis collaborates with ABL Europe to manufacture its SARS-CoV-2 Vaccine Candidate in France

May 12, 2020
Themis, a clinical-stage biopharmaceutical company focused on immunomodulation therapies for infectious diseases and cancer, and ABL Europe (ABL), a global Contract Development and…
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CRISPR and Vertex announce FDA RMAT designation granted to CTX001 to treat severe hemoglobinopathies

May 12, 2020
CRISPR Therapeutics and Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation…
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Enhertu granted Breakthrough Therapy Designation in the US for HER2-positive metastatic gastric…

May 12, 2020
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment…
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Dyno Therapeutics Emerges from Stealth to Transform Gene Therapy Using Artificial Intelligence

May 12, 2020
Dyno Therapeutics, Inc., a biotechnology company applying artificial intelligence (AI) to gene therapy, announced the company’s launch from stealth mode with its proprietary platform,…
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Press Releases

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