Blog
RSS FeedPosted by Michael Wonder on 23 Mar 2020
FDA and EMA collaborate to facilitate SARS-CoV-2 vaccine development
23 March 2020 - Vaccines offer a way to build immunity to a disease-causing microorganism before one has ever been exposed ...
Posted by Michael Wonder on 21 Mar 2020
Generating comparative evidence on new drugs and devices after approval
21 March 2020 - Certain limitations of evidence available on drugs and devices at the time of market approval often persist ...
Posted by Michael Wonder on 20 Mar 2020
Generating comparative evidence on new drugs and devices before approval
21 March 2020 - Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment ...
Posted by Michael Wonder on 20 Mar 2020
Coronavirus vindicates capitalism
19 March 2020 - Drug companies will save lives, even as Bernie Sanders is denouncing them. ...
Posted by Michael Wonder on 19 Mar 2020
FDA to fast track clinical trials for coronavirus therapies
19 March 2020 - FDA Commissioner Stephen Hahn said the agency will test chloroquine, an anti-malarial drug, as a coronavirus treatment. ...
Posted by Michael Wonder on 19 Mar 2020
Coronavirus (COVID-19) update: FDA continues to facilitate development of treatments
19 March 2020 - The U.S. FDA continues to play a critical role in the multifaceted all-of-government response to the ...
Posted by Michael Wonder on 18 Mar 2020
Hundreds of scientists scramble to find a Coronavirus treatment
17 March 2020 - In an ambitious international collaboration, researchers have “mapped” proteins in the coronavirus and identified 50 drugs to ...
Posted by Michael Wonder on 17 Mar 2020
Making a new vaccine is not a race, it is a lottery
17 March 2020 - The COVID-19 novel coronavirus outbreak has challenged global researchers to find a vaccine. ...
Posted by Michael Wonder on 15 Mar 2020
FDA finalises guidance for industry on applications for drugs with inadequate generic competition
13 March 2020 - Today, the U.S. FDA finalised guidance for industry, “Competitive Generic Therapies” (CGTs), which describes the process that ...
Posted by Michael Wonder on 09 Mar 2020
FDA proposes broad approach for conducting safety trials for type 2 diabetes medications
9 March 2020 - The U.S. FDA today issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety ...
Posted by Michael Wonder on 04 Mar 2020
Estimated research and development investment needed to bring a new medicine to market, 2009-2018
3 March 2020 - In this study, which included 63 of 355 new therapeutic drugs and biologic agents approved by the ...
Posted by Michael Wonder on 03 Mar 2020
'Get it done. We need it': Trump's coronavirus message to big pharma
3 March 2020 - President Donald Trump sought to show his personal engagement in the fight against coronavirus, meeting with ...
Posted by Michael Wonder on 20 Feb 2020
FDA names genes that may interact with specific drugs, offering clarity to genetic testing industry
20 February 2020 - The burgeoning industry built around telling patients how their genes may interact with specific drugs has ...
Posted by Michael Wonder on 19 Feb 2020
Understanding the role of comparative clinical studies in the development of oncology biosimilars
14 February 2020 - Biosimilars have the potential to broaden patient access to biologics and provide cost savings for health care ...
Posted by Michael Wonder on 16 Feb 2020
RWE: cost and time savings entice sponsors as pitfalls linger
14 February 2020 - The New England Journal of Medicine published an article earlier this week raising questions about the ...