Blog
RSS FeedPosted by Michael Wonder on 06 Jun 2019
FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials
5 June 2019 - Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the ...
Posted by Michael Wonder on 28 May 2019
Assessment of the clinical benefit of cancer drugs receiving accelerated approval
28 May 2019 - When a cancer drug that has received accelerated approval from the US FDA is claimed to have ...
Posted by Michael Wonder on 07 Sep 2017
Drug makers push back on data requirements in Australia’s provisional approval pathway
5 September 2017 - A who’s who of leading drug makers have raised concerns about the proposed data requirements for ...
Posted by Michael Wonder on 01 Sep 2017
Provisional approval pathway for prescription medicines
1 September 2017 - The TGA would like to thank respondents who provided submissions in response to the March 2017 ...
Posted by Michael Wonder on 16 Aug 2017
Flimsy evidence behind many FDA approvals
16 August 2017 - Many drugs granted accelerated approval by the U.S. FDA lack clear evidence of safety and effectiveness, ...
Posted by Michael Wonder on 15 Aug 2017
Characteristics of pre-approval and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration
15 August 2017 - The FDA granted accelerated approval to 22 drugs for 24 indications. ...
Posted by Michael Wonder on 09 Jun 2017
Bristol-Myers Squibb receives accelerated approval of Opdivo (nivolumab) from the US FDA
22 December 2014 - First approval of Opdivo in the US. ...
Posted by Michael Wonder on 08 Jun 2017
Major flaws in US drugs with 'accelerated' approval, research suggests
7 June 2017 - A new study published today has exposed major flaws in the fast tracking of some drugs ...
Posted by Michael Wonder on 04 Jun 2017
FDA approves Merck’s Keytruda (pembrolizumab) for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy
5 August 2016 - Merck today announced that the U.S. FDA has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death ...
Posted by Michael Wonder on 24 May 2017
Accelerated approval and expensive drugs — a challenging combination
24 May 2017 - For serious or life-threatening disease, the FDA can approve drugs on the basis of surrogate end points ...
Posted by Michael Wonder on 29 Apr 2017
Accelerating development of scientific evidence for medical products within the existing US regulatory framework
1 May 2017 - Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about ...
Posted by Michael Wonder on 29 Apr 2017
Takeda announces FDA accelerated approval of Alunbrig (brigatinib)
29 April 2017 - Alunbrig approved for ALK+ metastatic non-small-cell lung cancer patients who have progressed on or are intolerant ...
Posted by Michael Wonder on 18 Apr 2017
FDA grants Roche’s Tecentriq (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer
18 April 2017 - First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable ...
Posted by Michael Wonder on 30 Mar 2017
EU rapid drug approval plan worries some national HTA agencies
29 March 2017 - A push by the EMA to speed up the approval of new drugs that show promise ...
Posted by Michael Wonder on 20 Mar 2017
A better balance between accelerated access and high priced new drugs: a new conditional approval option
20 March 2017 - There are two different storms brewing in the pharmaceutical world. On the one hand there is ...