New medical treatments will use genetic scissors, and other clever tricks

13 November 2023 - New medicines to treat sickle cell disease and beta thalassaemia, two genetic blood disorders, will make headlines ...

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Statement from President Joe Biden on FDA approval of gene therapies to treat sickle cell disease

8 December 2023 - As we’ve seen throughout our history, when the US Government invests in innovation, we can achieve breakthroughs ...

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Blocking FDA approval of abortion pill could stifle innovation in the biopharma industry, experts say

13 April 2023 - If courts affirm US District Judge Matthew Kacsmaryk’s decision to suspend the FDA’s approval, it could make ...

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Digital health predictions: uncertainty will trigger innovation in 2023

7 February 2023 - It was an interesting year for digital health.  ...

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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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New Quality Innovation Expert Group supports medicine innovation

21 November 2022 - The EMA has established a Quality Innovation Expert Group to support innovative approaches for the development, ...

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FDA accepts Integral Molecular's letter of intent on membrane proteome array antibody specificity test into ISTAND drug development tools pilot program

7 September 2022 - Integral Molecular has been accepted into the US FDA's ISTAND pilot program.  ...

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The EU HTA regulation: a new frontier for access to innovative technologies

23 August 2022 - A new health technology regulation is due to be applied to help EU countries determine the effectiveness ...

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Regulatory considerations to keep pace with innovation in digital health products

19 August 2022 - Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital ...

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PRIME enables earlier availability of life-changing medicines

3 March 2022 - EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that ...

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How digital therapeutics platforms are revolutionising health care delivery

17 February 2022 - With enormous advances in digital health innovation, we are quickly moving into an age where software platforms ...

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Patent box legislation to promote Australian innovation

11 February 2022 - Medicines Australia notes the introduction of patent box legislation, Treasury Laws Amendment (Tax Concession for Australian ...

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New therapies for a range of conditions are coming in 2022

8 December 2021 - Haemophilia, brain disorders and malaria are being targeted. ...

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Competing with, and learning from, China in the global pharmaceutical innovation race

15 November 2021 - President Joe Biden has promoted investment in technology based industries, including the life sciences, as a strategic ...

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FDA, NIH and 15 private organisations join forces to increase effective gene therapies for rare diseases

27 October 2021 - The U.S. FDA, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organisations have partnered ...

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