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FDA Accepts for Priority Review the Supplemental Biologics License Application for Merck’s…

Dec 2, 2021
Merck, known as MSD outside the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License…
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AWS Helps Pfizer Accelerate Drug Development And Clinical Manufacturing

Dec 2, 2021
Amazon Web Services, Inc. (AWS), an Amazon.com, Inc. company, announced that it is working with Pfizer to create innovative, cloud-based solutions with the potential to improve how new…
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Premas Biotech and Oravax Medical to Test Their Triple Antigen Oral Vaccine Candidate Against…

Dec 2, 2021
Premas Biotech announced that its joint venture Oravax will initiate testing of their oral virus-like particle (VLP) vaccine candidate against Omicron variant of SARS-CoV 2 virus…
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Astellas and Dyno Therapeutics Announce Research Collaboration to Develop Next-Generation AAV Gene…

Dec 2, 2021
Astellas Pharma Inc. and Dyno Therapeutics, Inc. announced an option and license agreement was signed on November 23 to develop next-generation adeno-associated virus (AAV) vectors for…
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AbbVie Submits Application for Risankizumab (SKYRIZI) in Moderate to Severe Crohn’s Disease to…

Dec 1, 2021
AbbVie announced it has submitted an application to the European Medicines Agency (EMA) seeking approval for risankizumab (SKYRIZI, 600 mg intravenous (IV) induction and 360 mg…
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Lynparza granted Priority Review in the US for BRCA-mutated HER2-negative high-risk early breast…

Dec 1, 2021
AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) has been accepted and granted Priority Review in the US for the adjuvant treatment of patients with…
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Chiesi and UCB enter global license agreement for zampilimab a novel monoclonal antibody for…

Dec 1, 2021
UCB, a global biopharmaceutical company, and Chiesi Group, the international research-focused pharmaceutical and healthcare group, are pleased to announce that they have entered into an…
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Bone Therapeutics and Link Health sign a non-binding term sheet for the global rights of ALLOB

Dec 1, 2021
BONE THERAPEUTICS, the cell therapy company addressing unmet medical needs in orthopedics and other diseases, and Link Health Pharma Co., Ltd announce the signing of a non-binding term…
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FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination…

Dec 1, 2021
As we have with previous emerging COVID-19 variants, the U.S. Food and Drug Administration is actively working with our federal partners, international regulators and medical product…
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First Wave BioPharma Announces Independent Data Monitoring Committee Provides Positive Interim…

Dec 1, 2021
First Wave BioPharma, Inc., a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced…
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Press Releases

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