Novartis aims to beat rivals to novel $10 billion cancer treatment market

22 July 2021 - Trial results for new targeted therapy ‘pretty remarkable’, says CEO. ...

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International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines

16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...

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Update of EU recommendations for 2021–2022 seasonal flu vaccine composition

28 June 2021 - EMA has issued an update of the EU recommendations for the influenza virus strains that vaccine ...

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Success rate for marketing authorisation applications from SMEs doubles between 2016 and 2020

28 June 2021 - EMA has published today a report highlighting the Agency’s support for micro, small and medium sized ...

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FDA should lead the way on new ALS treatments, not Canada and Europe

22 June 2021 - Following the FDA’s recent decision to give the green light to aducanumab, the first treatment approved ...

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United States to spend $4.2 billion on anti-viral pills and other treatments for COVID-19

18 June 2021 - The United States is devoting $US3.2 billion ($4.2 billion) to speed development of antiviral pills to treat ...

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Rival treatments may help justify FDA gamble with Biogen Alzheimer’s drug

18 June 2021 - Data from clinical trials of three experimental Alzheimer’s disease drugs expected to start emerging next year ...

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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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