Blog
RSS FeedPosted by Michael Wonder on 07 Oct 2022
The critical role of academic clinical trials in paediatric cancer drug approvals: design, conduct, and fit for purpose data for positive regulatory decisions
6 October 2022 - For decades, academic clinical trials consortia have collaborated to optimise outcomes for childhood cancers through evaluating incremental ...
Posted by Michael Wonder on 14 Sep 2022
Improving dose optimisation processes used in oncology drug development to minimise toxicity and maximise benefit to patients
12 September 2022 - We reviewed US FDA initial approvals (2019-2021) of small molecules and antibody-drug conjugates for oncologic indications. ...
Posted by Michael Wonder on 22 Aug 2022
Three imperatives for R&D in biosimilars
19 August 2022 - The biosimilars market is poised to grow over the next decade. ...
Posted by Michael Wonder on 02 Aug 2022
FDA official: patients play an increasing role in rare disease drug development
1 August 2022 - Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful ...
Posted by Michael Wonder on 01 Aug 2022
Advancing innovative clinical trials to efficiently deliver medicines to patients
1 August 2022 - Complex innovative designs in clinical trials have the potential to increase efficiency and lower the cost of ...
Posted by Michael Wonder on 26 Jul 2022
‘No magic bullet’: For drug makers and the FDA, clinical trials on ultra rare diseases pose thorny challenges
26 July 2022 - Walker Burger is beside himself with worry. ...
Posted by Michael Wonder on 14 Jun 2022
FDA’s treatment of China developed drugs spurs demands for multiregional clinical trials
14 June 2022 - China’s ambition to become a leader in the biopharma industry has been clear in the last ...
Posted by Michael Wonder on 12 May 2022
Basket trials: review of current practice and innovations for future trials
10 May 2022 - Basket trials, one type of master protocol, emerged as a tool for evaluating biomarker-targeted therapies among multiple ...
Posted by Michael Wonder on 10 May 2022
FDA launches new Accelerating Rare disease Cures (ARC) program
10 May 2022 - FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the launch of the new ...
Posted by Michael Wonder on 09 Feb 2022
FDA raises concerns about China developed drugs
9 February 2022 - Agency could slow the plans of big Western drugmakers to sell Chinese tested medicines in U.S. ...
Posted by Michael Wonder on 16 Dec 2021
The wild west of checkpoint inhibitor development
15 December 2021 - Although immunotherapy development has improved overall survival among patients with common cancers and has led to important ...
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
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 ...