CDER director calls for simplifying clinical trials to boost diversity

10 January 2023 - Encouraging researchers and sponsors to simplify clinical trials and employ a fit for purpose protocol is ...

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An innovation surcharge to fund the repurposing of generic drugs

10 November 2022 - The use of generic drugs continues to increase, generating substantial savings for purchasers and improving affordable access ...

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Bristol Myers Squibb warns US price reforms will dent drug development

20 November 2022 - Biggest shake-up in pharma pricing in decades prompts companies to shelve some potential therapies. ...

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FDA continues to advance medicines for children

27 October 2022 - Increasing the availability of safe and effective medicines for children is a key priority for the US ...

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Tissue agnostic drug development in oncology

17 October 2022 - This guidance provides recommendations to sponsors regarding considerations for tissue agnostic drug development in oncology.  ...

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The critical role of academic clinical trials in paediatric cancer drug approvals: design, conduct, and fit for purpose data for positive regulatory decisions

6 October 2022 - For decades, academic clinical trials consortia have collaborated to optimise outcomes for childhood cancers through evaluating incremental ...

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Improving dose optimisation processes used in oncology drug development to minimise toxicity and maximise benefit to patients

12 September 2022 - We reviewed US FDA initial approvals (2019-2021) of small molecules and antibody-drug conjugates for oncologic indications. ...

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Patient registries: EMA officials highlight opportunities in orphan drug development

25 August 2022 - Officials from the EMA tout the benefits of patient registries to support regulatory decision making for ...

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Three imperatives for R&D in biosimilars

19 August 2022 - The biosimilars market is poised to grow over the next decade.  ...

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FDA official: patients play an increasing role in rare disease drug development

1 August 2022 - Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful ...

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Advancing innovative clinical trials to efficiently deliver medicines to patients

1 August 2022 - Complex innovative designs in clinical trials have the potential to increase efficiency and lower the cost of ...

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To promote innovation, Congress and companies should support drug development cost disclosure

28 July 2022 - Congress should pass the proposed Pharmaceutical Research Transparency Act of 2022 to mandate drug companies provide ...

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‘No magic bullet’: For drug makers and the FDA, clinical trials on ultra rare diseases pose thorny challenges

26 July 2022 - Walker Burger is beside himself with worry. ...

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FDA’s treatment of China developed drugs spurs demands for multiregional clinical trials

14 June 2022 - China’s ambition to become a leader in the biopharma industry has been clear in the last ...

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COVID mRNA vaccines can be quickly updated for new variants. So, where's my Omicron booster?

6 June 2022 - Since Omicron was declared a variant of concern at the end of November, it quickly swept ...

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