Blog
RSS FeedPosted by Michael Wonder on 24 Jun 2019
Incorporating patient preferences in non-inferiority trials
24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...
Posted by Michael Wonder on 20 Jun 2019
Sustainable discovery and development of antibiotics — is a non-profit approach the future?
19 June 2019 - Shifting to a nonprofit-driven model for development of antibiotics could encourage discovery and development of truly needed ...
Posted by Michael Wonder on 14 Jun 2019
Pharma blockchains AI for drug development
15 June 2019 - The venture would allow AI to be trained on millions of datapoints across databases from several drug ...
Posted by Michael Wonder on 06 Jun 2019
Pfizer denies report it hid possible Alzheimer’s breakthrough
5 June 2019 - Pfizer is fighting back against a report that it hid the potential of a blockbuster drug ...
Posted by Michael Wonder on 05 Jun 2019
Pharma groups combine to promote drug discovery with AI
5 June 2019 - Blockchain system allows companies to share data without revealing commercial secrets. ...
Posted by Michael Wonder on 05 Jun 2019
Pfizer knew drug may prevent Alzheimer's. Why didn't it tell us?
5 June 2019 - A team of researchers inside Pfizer made a startling find in 2015: the company's blockbuster rheumatoid ...
Posted by Michael Wonder on 02 May 2019
The antibiotic industry is broken
2 May 2019 - Take inspiration from the entertainment industry. ...
Posted by Michael Wonder on 02 May 2019
FDA's efforts to advance the development of gene therapy
1 May 2019 - Gene therapy has been on the horizon for several decades and has now become a reality in ...
Posted by Michael Wonder on 20 Apr 2019
FDA's efforts to advance the development of biologics
17 April 2019 - The FDA’s Center for Biologics Evaluation and Research is working at the forefront of 21st century ...
Posted by Michael Wonder on 10 Apr 2019
FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials
10 April 2019 - Can real-world evidence substitute for a clinical drug trial that meets the full gold standard on data? ...
Posted by Michael Wonder on 04 Apr 2019
The importance of predefined rules and pre-specified statistical analyses: do not abandon significance
4 April 2019 - For decades, statisticians and clinicians have debated the meaning of statistical and clinical significance. ...
Posted by Michael Wonder on 04 Apr 2019
FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development
4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When ...
Posted by Michael Wonder on 30 Mar 2019
Statement by FDA Commissioner, Director of FDA’s Center for Drug Evaluation and Research and Director of FDA’s Center for Biologics Evaluation and Research on expanded access–looking forward
29 March 2019 - For more than 30 years, the FDA has supported patients’ access to investigational medical products for ...
Posted by Michael Wonder on 28 Mar 2019
Drug makers continue to clamour for FDA approval of orphan drugs
28 March 2019 - Orphan drugs may serve small groups of patients, but they generate big numbers at the Food ...
Posted by Michael Wonder on 23 Mar 2019
FDA takes new steps to advance natural history studies for accelerating novel treatments for rare diseases
22 March 2019 - The U.S. FDA today issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development. ...