Blog
RSS FeedPosted 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FDA issues draft guidance to foster oncology product development for paediatric populations
12 December 2019 - Today, the U.S. FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of ...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 ...
Posted by Michael Wonder on 02 Oct 2019
The real impact of drug price legislation on biopharmaceutical R&D
2 October 2019 - As outcry around drug prices rages, arguments continue to surface that limiting corporate revenues via price controls ...
Posted by Michael Wonder on 01 Oct 2019
Novartis and Microsoft announce collaboration to transform medicine with artificial intelligence
1 October 2019 - Multi-year alliance underpins the Novartis commitment to leverage data & artificial intelligence to transform how medicines are ...
Posted by Michael Wonder on 30 Sep 2019
AI needs patients’ voices in order to revolutionise health care
30 September 2019 - Patients’ stories — what doctors call patient histories — are the bedrock of medicine. “Listen to ...
Posted by Michael Wonder on 30 Sep 2019
FDA issues draft guidance on patient-focused drug development: methods to identify what is important to patients
30 September 2019 - Today the U.S. FDA issued a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is ...
Posted by Michael Wonder on 22 Sep 2019
Interacting with the FDA on complex innovative trial designs for drugs and biological products
20 September 2019 - This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial ...