Blog
RSS FeedPosted by Michael Wonder on 02 Oct 2018
Boosting the development of medicines for children
2 October 2018 - The EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published ...
Posted by Michael Wonder on 28 Sep 2018
CDER conversation: complex innovative trial designs
25 September 2018 - Complex innovative trial designs – including the use of adaptive, Bayesian, and other novel statistical approaches ...
Posted by Michael Wonder on 26 Sep 2018
Chinese drug maker clarifies development strategy for bringing cancer drug to the U.S. market
26 September 2018 - It’s no secret that major biopharmaceutical companies have had designs on the China drug market as a ...
Posted by Michael Wonder on 26 Sep 2018
The health industry as an economic priority for Victoria, joint statement
26 September 2018 - Victoria has world-leading competitive advantages in the health industry, which encompasses health and medical research, biotechnology, ...
Posted by Michael Wonder on 26 Sep 2018
Early dialogue in Europe: perspectives on value, challenges, and continuing evolution
24 September 2018 - This study aims to assess participants’ views on previous experiences, the current situation and future perspectives for ...
Posted by Michael Wonder on 25 Sep 2018
Cost of clinical trials for new drug FDA approval are fraction of total tab
24 September 2018 - Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, ...
Posted by Michael Wonder on 18 Sep 2018
Harvard Professor's attack on pharma's clinical trials is absurd
18 September 2018 - Dr. Marcia Angell, a senior lecturer at Harvard Medical School and the first woman to serve as ...
Posted by Michael Wonder on 17 Sep 2018
Antimicrobial resistance: FDA discusses reimbursement reforms
17 September 2018 - Reimbursement reforms for antimicrobial treatments could include “a mix of milestone payments and subscription fees for ...
Posted by Michael Wonder on 10 Sep 2018
Endocyte announces FDA acceptance of radiographic progression free survival as an alternative primary endpoint of the VISION trial in addition to overall survival
10 September 2018 - Demonstrating benefit in rPFS versus control, with no detriment to OS, sufficient for full approval. ...
Posted by Michael Wonder on 05 Sep 2018
The path to the first FDA approved cannabis-derived treatment and what comes next
5 September 2018 - Harvard neurologist Elizabeth Thiele is only half-kidding about the surprising direction her research has taken. ...
Posted by Michael Wonder on 31 Aug 2018
Choice of control group in randomised trials of cancer medicine: are we testing trivialities?
31 August 2018 - Several trials in cancer medicine over the past 5 years share two common features: first, they were ...
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 29 Aug 2018
FDA launches new pilot to advance innovative clinical trial designs as part of agency’s broader program to modernise drug development and promote innovation in drugs targeted to unmet needs
29 August 2018 - Today, the U.S. FDA announced a new pilot program (“Complex Innovative Designs Pilot Meeting Program”) in which ...
Posted by Michael Wonder on 25 Aug 2018
FDA says sponsors should limit placebo controlled trials in cancer
23 August 2018 - FDA released draft guidance on Thursday to debunk the notion that FDA requires the use of ...
Posted by Michael Wonder on 22 Aug 2018
Statement by FDA Commissioner on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics
22 August 2018 - As we all work to confront the staggering human and economic toll created by the opioid crisis, ...