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Advancing and Safeguarding Clinical Research for a Better Tomorrow

Advarra

Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy. Advarra draws members from leading academic institutions, government agencies, and clinical research organizations.

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Hyman, Phelps & McNamara Enters its 45th Year Continuing to Expand its Capabilities to Meet Client Needs

FDA Law Blog: Biosimilars

In her distinguished FDA career, Dr. Lowy provided thought leadership in drug policy and product development for rare endocrinologic diseases, opioids, sarcopenia, and cancer cachexia. Before her legal career, Julie worked as a nurse practitioner specializing in neurosurgery and infectious diseases.

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Eurofins U.S. Clinical Diagnostics Network Receives EUA Approval of At Home COVID-19 Test

The Pharma Data

Eurofins’ infectious disease centre for excellence, Viracor , developed the test based on its highly sensitive, FDA EUA-authorized SARS-CoV-2 RT-PCR assay. Available through the Eurofins direct-to-consumer company, empowerDX , the at home test can be ordered online ( [link] ) for $89. The Eurofins U.S.

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Moderna’s FDA COVID-19 Vaccine Adcom is Thursday, and Expectations are High

The Pharma Data

ICU nurse Sandra Lindsay, with Long Island Jewish Medical Center in Queens, New York, received the Pfizer-BioNTech COVID-19 vaccine. government’s Operation Warp Speed, Moderna has been working with the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID). pcruciatti / Shutterstock.

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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

Have chronic kidney disease. Have immunosuppressive disease. cardiovascular disease, OR. chronic obstructive pulmonary disease/other chronic respiratory disease. sickle cell disease, OR. congenital or acquired heart disease, OR. Have diabetes. Are currently receiving immunosuppressive treatment.

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Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government’s Operation Warp Speed goals. Have chronic kidney disease. cardiovascular disease, OR.

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Health Care Workers, Nursing Home Residents to Get First Vaccines: Panel

The Pharma Data

1, 2020 — Health care workers and people in nursing homes should be at the front of the line for upcoming COVID-19 vaccines, a U.S. Centers for Disease Control and Prevention advisory panel recommended Tuesday. TUESDAY, Dec. Food and Drug Administration hasn’t yet authorized the two leading vaccines for emergency use.