Blog
RSS FeedPosted by Michael Wonder on 10 Dec 2021
International regulators stress continued need for COVID-19 therapeutics
11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...
Posted by Michael Wonder on 09 Dec 2021
FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data ...
Posted by Michael Wonder on 08 Dec 2021
Don’t destroy future drug development
8 December 2021 - With support faltering for the massive big-government blowout Congress is trying to jam through by Christmas, ...
Posted by Michael Wonder on 08 Dec 2021
FDA takes new steps aimed at advancing development of individualised medicines to treat genetic diseases
7 December 2021 - Today, the FDA is issuing a draft guidance to provide recommendations for managing the administration of individualised ...
Posted by Michael Wonder on 29 Nov 2021
FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products
29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...
Posted by Michael Wonder on 11 Nov 2021
FDA touts success and challenges in biosimilar development
10 November 2021 - A top official from the US FDA offered a mixed assessment of the agency’s biosimilars program, noting ...
Posted by Michael Wonder on 08 Nov 2021
Why does the FDA want to stop improving medicines via patent ‘areas of concern’?
8 November 2021 - It’s hardly unprecedented for one federal agency to encroach on another’s turf. But the latest intra-executive-branch ...
Posted by Michael Wonder on 04 Nov 2021
Funding hole makes cracking COVID-19 vaccine code a tougher ask
4 November 2021 - Australia has the expertise to crack the code in the biggest challenge facing the COVID-19 vaccination ...
Posted by Michael Wonder on 28 Oct 2021
Repurposing of authorised medicines: pilot to support not for profit organisations and academia
28 October 2021 - EMA and the Heads of Medicines Agencies are launching a pilot project to support the repurposing ...
Posted 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 ...