News

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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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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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, 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, 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 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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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, 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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Acer Therapeutics Inc. announced it has entered into a research collaboration agreement with the National Center for Advancing Translational Sciences (NCATS), one of the National…
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The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These…
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Sorrento Therapeutics, Inc. and Mount Sinai Health System have agreed to join forces in the investigation and development of an antibody cocktail (COVI-SHIELD) to potentially treat…
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Recipharm has now secured supply of the active pharmaceutical ingredient (API) chloroquine phosphate for its drug Klorokinfosfat RPH Pharma and commenced manufacture of the product.…
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To accelerate national, multi-institutional efforts focused on mapping coronavirus transmission and epidemiological studies, Thermo Fisher Scientific announces the SARS-CoV-2…
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Schreiner MediPharm has developed a compact Booklet-Label for a needle protection system used in an international phase III clinical trial conducted by pharmaceutical corporation…
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Pfizer Inc. and BioNTech SE announced that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. The…
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Gilead Sciences, Inc. announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury (remdesivir) as a treatment for SARS-CoV-2…
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CluePoints, the premier provider of Risk-Based Quality Management (RBQM) and Data Quality Oversight Software for clinical trials, announced that its recently launched complimentary…
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ZYUS Life Sciences Inc., a company dedicated to improving quality of life through research and leadership in bio-pharmaceuticals and the development of innovative cannabinoid-based…
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Humanigen, Inc. a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered anti-human granulocyte…
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Lineage Cell Therapeutics, Inc. a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced that Cancer Research UK’s Commercial…
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