Taxpayers are funding expensive drug development, report says

10 May 2019 - The Dutch government invests tens of millions of euros every year in small biotech companies which ...

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The antibiotic industry is broken

2 May 2019 - Take inspiration from the entertainment industry. ...

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FDA's efforts to advance the development of gene therapy

1 May 2019 - Gene therapy has been on the horizon for several decades and has now become a reality in ...

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FDA's efforts to advance the development of biologics

17 April 2019 - The FDA’s Center for Biologics Evaluation and Research is working at the forefront of 21st century ...

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Labor to fast-track leukaemia drug trials

17 April 2019 - Patients with deadly blood cancers will get faster access to potentially life-saving drug trials if Labor ...

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FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials

10 April 2019 - Can real-world evidence substitute for a clinical drug trial that meets the full gold standard on data? ...

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Minimal residual disease as a surrogate outcome for product development for multiple myeloma: comparing FDA and EMA guidances

8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease ...

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The importance of predefined rules and pre-specified statistical analyses: do not abandon significance

4 April 2019 - For decades, statisticians and clinicians have debated the meaning of statistical and clinical significance.  ...

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FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development

4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When ...

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Statement by FDA Commissioner, Director of FDA’s Center for Drug Evaluation and Research and Director of FDA’s Center for Biologics Evaluation and Research on expanded access–looking forward

29 March 2019 - For more than 30 years, the FDA has supported patients’ access to investigational medical products for ...

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Drug makers continue to clamour for FDA approval of orphan drugs

28 March 2019 - Orphan drugs may serve small groups of patients, but they generate big numbers at the Food ...

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Take over pharma to create new medicines, says top adviser

27 March 2019 - Part of the drugs industry should be taken over to make new antibiotics, an influential economist ...

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FDA takes new steps to advance natural history studies for accelerating novel treatments for rare diseases

22 March 2019 - The U.S. FDA today issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development.  ...

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FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in paediatric patients, as part of efforts to end HIV infection

19 March 2019 - The U.S. FDA today issued two final guidances for industry to help product sponsors understand the ...

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Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development

14 March 2019 - Modernizing clinical trials is an agency wide priority.  ...

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