Blog
RSS FeedPosted by Michael Wonder on 07 Oct 2024
Crossing the equity chasm: addressing a second valley of death in biomedical innovation
3 October 2024 - Traditionally, the term valley of death refers to the gap where advancements in basic research fail to ...
Posted by Michael Wonder on 12 Jul 2024
Incorporating real option value in valuing innovation: a way forward
10 July 2024 - Considerable progress has been made in defining and measuring the real option value of medical technologies. ...
Posted by Michael Wonder on 01 Jan 2024
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 ...
Posted by Michael Wonder on 08 Dec 2023
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 ...
Posted by Michael Wonder on 13 Apr 2023
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 ...
Posted by Michael Wonder on 11 Feb 2023
Digital health predictions: uncertainty will trigger innovation in 2023
7 February 2023 - It was an interesting year for digital health. ...
Posted by Michael Wonder on 07 Dec 2022
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 ...
Posted by Michael Wonder on 21 Nov 2022
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, ...
Posted by Michael Wonder on 07 Sep 2022
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. ...
Posted by Michael Wonder on 23 Aug 2022
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 ...
Posted by Michael Wonder on 20 Aug 2022
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 ...
Posted by Michael Wonder on 03 Mar 2022
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 ...
Posted by Michael Wonder on 19 Feb 2022
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 ...
Posted by Michael Wonder on 10 Feb 2022
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 ...
Posted by Michael Wonder on 08 Dec 2021
New therapies for a range of conditions are coming in 2022
8 December 2021 - Haemophilia, brain disorders and malaria are being targeted. ...