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Gut Feeling about Drugs: How the Microbiome Shapes Drug Response
Shruti Talashi
February 05, 2024
About 10-100 trillion symbiotic microbial cells are carried by each individual, mostly in the gut, that are known as the human microbiota.
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FDA issues new guidance for developers of COVID-19 vaccines, diagnostics and therapeutics
europeanpharmaceuticalreview
February 24, 2021
The new recommendations address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants.
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Turning Point Therapeutics and Zai Lab Announce Exclusive License Agreement for Repotrectinib in Greater China
prnasia
July 08, 2020
Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, and Zai Lab (NASDAQ: ZLAB), an innovative commercial-stage biopharmaceutical company, today announced
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EMA to fast-track development of COVID-19 vaccines and therapeutics
europeanpharmaceuticalreview
May 08, 2020
The EMA has announced new regulatory changes that will help potential COVID-19 vaccines and therapeutics accelerate through development.
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United Therapeutics Announces FDA Acceptance of Trevyent New Drug Application For Review
drugs
September 16, 2019
United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary...
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Jubilant Therapeutics Appoints President and CEO
contractpharma
September 16, 2019
Syed Kazmi's accomplished career includes 25 years in M&A, licensing, strategic collaborations, and R&D in specialty biotech and large pharma.
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Vertex to buy Semma Therapeutics for $950m
pharmaceutical-technology
September 05, 2019
Vertex Pharmaceuticals will acquire all outstanding shares of biotechnology firm Semma Therapeutics for a cash sum of $950m.
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Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc.
worldpharmanews
September 04, 2019
Roche and Spark Therapeutics, Inc. (NASDAQ: ONCE) ("Spark") today announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares...
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Marker Therapeutics Appoints Regulatory Affairs VP
contractpharma
August 19, 2019
Dr. Agopyan brings more than 15 years of industry knowledge in regulatory affairs and clinical development.
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TCR2 Therapeutics Expands Leadership Team
contractpharma
August 07, 2019
Aims to support clinical trials with an emphasis on manufacturing, IND enablement and development of next generation of TRuC-T cells.