Blog
RSS FeedPosted 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9 March 2020 - The U.S. FDA today issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety ...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 ...
Posted by Michael Wonder on 29 Jan 2020
Understanding the rewards of successful drug development — thinking inside the box
30 January 2020 - Risks and rewards change during the life cycle of a drug. In the innovation period, drug companies ...
Posted by Michael Wonder on 28 Jan 2020
FDA continues strong support of innovation in development of gene therapy products
28 January 2020 - This is a pivotal time in the field of gene therapy as the FDA continues its ...
Posted by Michael Wonder on 12 Dec 2019
FDA issues draft guidance to foster oncology product development for paediatric populations
12 December 2019 - Today, the U.S. FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of ...
Posted by Michael Wonder on 10 Dec 2019
Do large pharma companies provide drug development innovation? Our analysis says no.
10 December 2019 - Large pharmaceutical companies oppose legislation being considered by Congress to lower the prices of prescription drugs. ...
Posted by Michael Wonder on 07 Nov 2019
The FDA needs to set standards for using artificial intelligence in drug development
7 November 2019 - Artificial intelligence has become a crucial part of our technological infrastructure and the brain underlying many ...
Posted by Michael Wonder on 15 Oct 2019
Wanted: better policies and incentives to revitalise R&D for new antimicrobial drugs
15 October 2019 - In the not-too-distant future that we could be facing — one with rampant, uncontrollable, multidrug-resistant microbes ...
Posted by Michael Wonder on 10 Oct 2019
FDA cuts red tape in diagnosis applications for cancer trials
10 October 2019 - Drug companies developing cancer treatments can fold the risk assessment of unapproved screening tests into their ...
Posted by Michael Wonder on 08 Oct 2019
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
8 October 2019 - The U.S. FDA today announced that it has awarded 12 new clinical trial research grants totaling ...