Scientists are working diligently to learn more about the Coronavirus and health boards are changing guidance to adapt to
this newly available information. The response to this information varies on a regional and country level as does regulatory
and submission guidance
Roche today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA)1 for its new Elecsys® Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2...
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MAINZ, Germany and NEW YORK, April 22, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Pfizer Inc. (NYSE: PFE), have announced today that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent COVID-19 infection.
Sanofi and Luminostics have signed an agreement to evaluate a collaboration on a unique self-testing solution for COVID-19, using Luminostics’ innovative technology, and further adding to Sanofi’s ongoing efforts to fight the COVID-19 pandemic on multiple fronts.
Sanofi and GSK today announce that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic.
Mesoblast Limited (ASX:MSB;
Nasdaq: MESO), global leader in cellular medicines for inflammatory diseases, today announced that it has
received clearance from the United States Food and Drug Administration (FDA)
Celltrion Group today announced its successful transition to the second phase of development for an antiviral treatment to fight the novel coronavirus (COVID-19) pandemic, following the completion of the first phase of securing 300 different types of antibodies that bind to the antigen last month. The library of antibodies was created using the blood of recovered patients in Korea.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Vertex Foundation, a nonprofit charitable foundation, commits to make donations totaling $5 million in 2020 to support global COVID-19 relief efforts, including doubling its match for employees’ charitable donations to eligible organizations responding to the COVID-19 pandemic.
CROMSOURCE, an international contract research organization (CRO) with its global headquarters in Verona, Italy, has announced that it has initiated its first COVID-19 trial on behalf of a European pharmaceutical company.
Zegami, the Oxford University data visualisation spin-out, has developed a new machine learning model using x-rays of Covid-19 infected lungs, artificial intelligence techniques and data visualisation tools that could help medical professionals identify Coronavirus cases more effectively, but also potentially help provide a better idea of potential outcomes for patients, and even lead to more effective treatments.
GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.
The safety of clinical trial patients and staff is paramount. We are working with our clients in pharma and CROs to assess each trial to see if it needs to be suspended, delayed or if it can carry on in a way that is safe both for the clinicians and participants