European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines

22 June 2020 - Senior officials from the European Commission, EMA and the United States FDA held their 2020 bilateral ...

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Regulators discuss accelerated approvals, Project Orbis at DIA

16 June 2020 - Regulators from the US FDA, European Medicines Agency and Health Canada gave their perspectives on different ...

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Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): an unprecedented partnership for unprecedented times

18 May 2020 - It has been more than a century since the world has encountered a pandemic like coronavirus disease ...

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Russia says search for a coronavirus treatment should not be a medical ‘arms race’

14 May 2020 - Russia’s sovereign wealth fund has been funding Russian development and production of the drug favipiravir, an anti-influenza ...

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NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options

17 April 2020 - The National Institutes of Health (NIH) and the Foundation for the NIH are bringing together more than ...

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Global plasma leaders collaborate to accelerate development of potential COVID-19 hyperimmune therapy

6 April 2020 - Partnership brings together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the ...

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COVID-19 has changed how the world does science, together

1 April 2020 - Never before, scientists say, have so many of the world’s researchers focused so urgently on a single ...

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Crowdsourcing to fight COVID-19

26 March 2020 - “We are trying to fly the plane while we are building it.”  ...

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FDA continues to support transparency and collaboration in drug approval process as the clinical data summary pilot concludes

26 March 2020 - As our society becomes more global, it has become increasingly clear that the U.S. FDA needs to ...

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Novartis and life sciences companies commit expertise and assets to the fight against COVID-19 pandemic alongside Bill & Melinda Gates Foundation

26 March 2020 - Collaboration to address product development and scale up challenges posed by current pandemic. ...

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FDA and EMA collaborate to facilitate SARS-CoV-2 vaccine development

23 March 2020 - Vaccines offer a way to build immunity to a disease-causing microorganism before one has ever been exposed ...

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Teva, drug makers in talks with U.S. to end generics probes

26 November 2019 - Deferred prosecution agreements among resolutions discussed. ...

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FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia

21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...

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FDA’s Project Orbis may expand to Singapore and Switzerland

12 November 2019 - The US FDA may expand a pilot project that allows for simultaneous drug approval decisions from ...

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Patient perspective is vital to FDA's work

7 November 2019 - As an oncologist, I was eager to come work at the U.S. FDA, where I knew ...

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