Blog
RSS FeedPosted by Michael Wonder on 10 Jun 2021
Integrating early economic evaluation into target product profile development for medical tests: advantages and potential applications
7 June 2021 - Target product profiles outline the characteristics that new health care technologies require to address an unmet clinical ...
Posted by Michael Wonder on 04 Mar 2021
Modified COVID-19 vaccines for variants to be fast-tracked, says MHRA and other regulators
4 March 2021 - Future vaccine modifications that respond to new variants of coronavirus to be made available quickly to UK recipients, without compromising on safety, ...
Posted by Michael Wonder on 01 Mar 2021
Rare Disease Day 2021: FDA shows sustained support of rare disease product development during the public health emergency
1 March 2021 - Rare Disease Day is a time to reflect on both the progress that has been made, and ...
Posted by Michael Wonder on 25 Feb 2021
Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...
Posted by Michael Wonder on 09 Feb 2021
Collaboration between the FDA and industry is essential to foster innovation in Alzheimer’s treatments
8 February 2021 - As the Food and Drug Administration moves closer to a decision about whether to approve a ...
Posted by Michael Wonder on 03 Feb 2021
New toolbox available for EMA's PRIME designees
2 February 2021 - The European Medicines Agency has released a draft guidance to assist drug developers using its Priority ...
Posted by Michael Wonder on 14 Jan 2021
FDA releases artificial intelligence/machine learning action plan
12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...
Posted by Michael Wonder on 09 Dec 2020
Blunders eroded U.S. confidence in early vaccine front-runner
8 December 2020 - The Oxford-AstraZeneca effort held great promise to help arrest the pandemic. But a series of miscues caused ...
Posted by Michael Wonder on 23 Nov 2020
Workshop on regulatory support for development of orphan medicines
23 November 2020 - On Monday, 30 November, EMA is hosting a workshop to discuss the benefits and impact of ...
Posted by Michael Wonder on 23 Nov 2020
Politics, science and the remarkable race for a coronavirus vaccine
21 November 2020 - The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical ...
Posted by Michael Wonder on 22 Oct 2020
Oxford developed COVID-19 vaccine, then scholars clashed over money
21 October 2020 - Early deal with Merck was scotched for fear poor countries would be left out; now university could ...
Posted by Michael Wonder on 15 Oct 2020
EMA cancer symposium: new approaches in patient-focused cancer medicine development
15 October 2020 - On Thursday, 29 October, EMA is hosting a symposium to discuss new approaches to facilitating and ...
Posted by Michael Wonder on 08 Oct 2020
Accounting for US public funding in drug development: how can we better balance access, affordability, and innovation?
8 October 2020 - US drug prices are the highest in the world and are continuing to rise, with an increasing ...
Posted by Michael Wonder on 02 Oct 2020
Biotech industry pushes Trump Administration to release new vaccine guidelines
2 October 2020 - The BIO trade group, whose members include most of the vaccine makers, asked the health secretary to ...
Posted by Michael Wonder on 29 Sep 2020
Pfizer CEO on the pressures of creating a COVID-19 vaccine: ‘what is at stake is beyond imagination'
30 September 2020 - Albert Bourla, 58, is chairman and chief executive of Pfizer, a multinational pharmaceutical company. Bourla is a ...