Integrating early economic evaluation into target product profile development for medical tests: advantages and potential applications

7 June 2021 - Target product profiles outline the characteristics that new health care technologies require to address an unmet clinical ...

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Modified COVID-19 vaccines for variants to be fast-tracked, says MHRA and other regulators

4 March 2021 - Future vaccine modifications that respond to new variants of coronavirus to be made available quickly to UK recipients, without compromising on safety, ...

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Rare Disease Day 2021: FDA shows sustained support of rare disease product development during the public health emergency

1 March 2021 - Rare Disease Day is a time to reflect on both the progress that has been made, and ...

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Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers

25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...

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Collaboration between the FDA and industry is essential to foster innovation in Alzheimer’s treatments

8 February 2021 - As the Food and Drug Administration moves closer to a decision about whether to approve a ...

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New toolbox available for EMA's PRIME designees

2 February 2021 - The European Medicines Agency has released a draft guidance to assist drug developers using its Priority ...

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FDA releases artificial intelligence/machine learning action plan

12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...

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Blunders eroded U.S. confidence in early vaccine front-runner

8 December 2020 - The Oxford-AstraZeneca effort held great promise to help arrest the pandemic. But a series of miscues caused ...

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Workshop on regulatory support for development of orphan medicines

23 November 2020 - On Monday, 30 November, EMA is hosting a workshop to discuss the benefits and impact of ...

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Politics, science and the remarkable race for a coronavirus vaccine

21 November 2020 - The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical ...

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Oxford developed COVID-19 vaccine, then scholars clashed over money

21 October 2020 - Early deal with Merck was scotched for fear poor countries would be left out; now university could ...

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EMA cancer symposium: new approaches in patient-focused cancer medicine development

15 October 2020 - On Thursday, 29 October, EMA is hosting a symposium to discuss new approaches to facilitating and ...

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Accounting for US public funding in drug development: how can we better balance access, affordability, and innovation?

8 October 2020 - US drug prices are the highest in the world and are continuing to rise, with an increasing ...

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Biotech industry pushes Trump Administration to release new vaccine guidelines

2 October 2020 - The BIO trade group, whose members include most of the vaccine makers, asked the health secretary to ...

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Pfizer CEO on the pressures of creating a COVID-19 vaccine: ‘what is at stake is beyond imagination'

30 September 2020 - Albert Bourla, 58, is chairman and chief executive of Pfizer, a multinational pharmaceutical company. Bourla is a ...

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