Blog
RSS FeedPosted by Michael Wonder on 22 Jul 2021
Novartis aims to beat rivals to novel $10 billion cancer treatment market
22 July 2021 - Trial results for new targeted therapy ‘pretty remarkable’, says CEO. ...
Posted by Michael Wonder on 16 Jul 2021
International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines
16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...
Posted by Michael Wonder on 29 Jun 2021
Update of EU recommendations for 2021–2022 seasonal flu vaccine composition
28 June 2021 - EMA has issued an update of the EU recommendations for the influenza virus strains that vaccine ...
Posted by Michael Wonder on 28 Jun 2021
Success rate for marketing authorisation applications from SMEs doubles between 2016 and 2020
28 June 2021 - EMA has published today a report highlighting the Agency’s support for micro, small and medium sized ...
Posted by Michael Wonder on 23 Jun 2021
FDA should lead the way on new ALS treatments, not Canada and Europe
22 June 2021 - Following the FDA’s recent decision to give the green light to aducanumab, the first treatment approved ...
Posted by Michael Wonder on 20 Jun 2021
United States to spend $4.2 billion on anti-viral pills and other treatments for COVID-19
18 June 2021 - The United States is devoting $US3.2 billion ($4.2 billion) to speed development of antiviral pills to treat ...
Posted by Michael Wonder on 18 Jun 2021
Rival treatments may help justify FDA gamble with Biogen Alzheimer’s drug
18 June 2021 - Data from clinical trials of three experimental Alzheimer’s disease drugs expected to start emerging next year ...
Posted 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 ...