Blog
RSS FeedPosted by Michael Wonder on 13 Sep 2018
Can a cancer drug originated in China be a success in the U.S.?
13 September 2018 - While China has prospered in a variety of technologies over the last decade, one area where growth ...
Posted by Michael Wonder on 13 Sep 2018
BIO, Allergan and Roche call for FDA flexibility with patient experience data
13 September 2018 - Industry group BIO and biopharma companies Allergan and Roche are calling for the FDA to be ...
Posted by Michael Wonder on 06 Sep 2018
Hospitals are fed up with drug companies, so they’re starting their own
6 September 2018 - A group of major American hospitals, battered by price spikes on old drugs and long-lasting shortages ...
Posted by Michael Wonder on 05 Sep 2018
Statement from FDA Commissioner on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities
5 September 2018 - Over the past 25 years, globalisation of drug manufacturing has prompted the FDA to change its ...
Posted by Michael Wonder on 29 Aug 2018
FDA pushes for development of non-opioid pain medications
29 August 2018 - The FDA is planning new steps to encourage the development of nonaddictive alternatives to opioid pain ...
Posted by Michael Wonder on 28 Aug 2018
Pfizer calls for FDA guidance to address false and misleading biosimilar advertisements
28 August 2018 - Taking issue with Amgen, Genentech and other reference product sponsors’ dissemination of misleading information on biosimilars, ...
Posted by Michael Wonder on 23 Aug 2018
FDA adds four tropical diseases to priority review voucher program to encourage drug development in areas of unmet need
23 August 2018 - Today, the U.S. FDA announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis ...
Posted by Michael Wonder on 01 Aug 2018
FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development
1 August 2018 - We know that novel manufacturing technologies for both small-molecule drugs and biological products have great potential to ...
Posted by Michael Wonder on 26 Jul 2018
Drug companies can’t game paediatric drug laws anymore
26 July 2018 - Drug companies can’t avoid including kids in certain clinical studies now that the FDA has finally ...
Posted by Michael Wonder on 13 Jul 2018
FDA budget matters: investing in advanced domestic manufacturing
13 July 2018 - There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring ...
Posted by Michael Wonder on 10 Jul 2018
Medicines Australia welcomes priority review pathway programme milestone
10 July 2018 - Last week saw the listing of Eryland (apalutamide) for the treatment men with non-metastatic (castration-resistant) prostate ...
Posted by Michael Wonder on 03 Jul 2018
Deloitte survey finds biopharma companies are accelerating adoption of real-world evidence
28 June 2018 - A recent survey shows that 90% of biopharma companies are making significant investments in real-world evidence ...
Posted by Michael Wonder on 28 Jun 2018
The biopharmaceutical industry provides 75% of the FDA's drug review budget. Is this a problem?
28 June 2018 - Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its ...
Posted by Michael Wonder on 28 Jun 2018
Bias, operational bias, and generalisability in Phase II/III trials
27 June 2018 - Adaptive clinical trial designs improve the efficiency of the drug development process by allowing treatment decisions to ...
Posted by Michael Wonder on 25 Jun 2018
As the drug industry eyes the burgeoning biosimilar market, its united front is starting to crack
25 June 2018 - The pharmaceutical industry’s massive lobbying operation has a well-earned reputation for maintaining a united front on ...