FDA plans to release AI drug development guidance this year

30 May 2024 - The US FDA plans to release a draft guidance this year on the use of artificial intelligence/machine ...

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FDA considers new efficacy endpoint for diabetes drugs

31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for ...

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Inflation Reduction Act undermines cancer medicine development

1 June 2023 - The price setting provisions in the Inflation Reduction Act acutely impact the research and development (R&D) ...

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Transferable exclusivity voucher: a flawed incentive to stimulate antibiotic innovation

9 February 2023 - As antibiotic resistance increases globally, antibiotic innovation is struggling. The WHO states that the antibiotic clinical pipeline ...

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State of the Union highlights America’s awkward conversation on financing the development of new medicines

9 February 2023 - Science, medicine, health care, and paying for medicines featured prominently in President Joe Biden’s State of ...

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Actions to support the development of medicines for children

6 February 2023 - Regulators in the European Union have taken several initiatives in the past four years to increase the ...

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FDA finalises umbrella trial guidance for cell and gene therapies

4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or ...

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EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products

29 September 2022 - EMA is launching a pilot to support the translation of basic research developments into medicines that could ...

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EU watchdog says supports fast development of Omicron only vaccine

3 February 2022 - The European Union's drug regulator said on Thursday it would support a filing for approval of ...

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The BBB’s threat to biosimilar drug development

23 November 2021 - In 2019, longtime pharmaceutical industry critic, Peter Bach, took to the Wall Street Journal to declare that ...

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How much does it cost to research and develop a new drug? A systematic review and assessment

15 October 2021 - Debate over the viability of the current commercial research and development model is on-going.  ...

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Canada should negotiate a fairer share of drug R&D costs

23 September 2021 - Instead of relying on price regulation, Canada should engage in negotiations about drug pricing. ...

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FDA guidance says sponsors should provide 'convincing' proof of concept data to support INDs for individualised medicine

26 April 2021 - Recent draft guidance from the US FDA addresses the non-clinical safety data to support investigational new ...

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Cancer researcher David Thomas says more should be done attract big pharma

18 April 2021 - A Garvan Institute cancer researcher says the government needs to attract big pharmaceutical companies to Australia ...

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MHRA pilot seeks evidence of patient involvement in R&D

25 March 2021 - The UK MHRA has begun a pilot project to encourage patient involvement in drug development, asking ...

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