Blog
RSS FeedPosted by Michael Wonder on 03 Sep 2019
The FDA and Sarepta: a window into the real world of drug regulation
3 September 2019 - It is hard to discern the true state of drug regulation from the outside, but two ...
Posted by Michael Wonder on 02 Sep 2019
Biosimilars Forum’s public letter in response to anti-biosimilars Op-Ed
29 August 2019 - Government Should Not “Throw In the Towel on Biosimilars,” They Should Act Now to Unlock Billions ...
Posted by Michael Wonder on 02 Sep 2019
Genentech provides update on supplemental biologics licence application for Tecentriq in first-line metastatic non-squamous non-small cell lung cancer
30 August 2019 - Genentech was notified by the U.S. FDA that the review period for the supplemental biologics license application ...
Posted by Michael Wonder on 30 Aug 2019
SpringWorks Therapeutics receives breakthrough therapy designation for nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumours
29 August 2019 - SpringWorks Therapeutics today announced the U.S. FDA has granted breakthrough therapy designation for nirogacestat, an oral, selective, ...
Posted by Michael Wonder on 29 Aug 2019
U.S. FDA approves Mylan generic of Lilly lung cancer drug Alimta
29 August 2019 - The U.S. Food and Drug Administration on Thursday granted Mylan tentative approval for its generic version ...
Posted by Michael Wonder on 29 Aug 2019
Academics and consumer groups protest FDA plan to summarise review documents
29 August 2019 - A Food and Drug Administration proposal to substitute detailed reviews of new drugs written by specific ...
Posted by Michael Wonder on 29 Aug 2019
Are reasonable restraints on drug price increases doomed by pharma lobbying?
29 August 2019 - In a rare but important display of congressional bipartisanship, Senators Chuck Grassley (R-Iowa) and Ron Wyden ...
Posted by Michael Wonder on 29 Aug 2019
Zensun announces the investigation of Neucardin for chronic heart failure receives fast track designation from the US FDA
26 August 2019 - Zensun announced that the investigation of Neucardin, its recombinant human neuregulin-1 fragment, has received fast track designation ...
Posted by Michael Wonder on 29 Aug 2019
Emalex Biosciences receives FDA fast track designation for ecopipam for the treatment of patients with Tourette syndrome
28 August 2019 - Emalex Biosciences announced today that it has received fast track designation for its investigational product, ecopipam, from ...
Posted by Michael Wonder on 28 Aug 2019
Promoting paediatric drug research and labelling — outcomes of legislation
28 August 2019 - Congress has modified regulations of the FDA to promote research assessing the efficacy and safety of drugs ...
Posted by Michael Wonder on 28 Aug 2019
FDA urges inclusion of men in breast cancer clinical trials
28 August 2019 - Men with breast cancer make up less than one percent of all breast cancer cases, but ...
Posted by Michael Wonder on 28 Aug 2019
Placebos and blinding in randomised controlled cancer clinical trials for drug and biological products: guidance for industry
28 August 2019 - This guidance provides recommendations to industry about the use of placebos and blinding in randomised controlled clinical ...
Posted by Michael Wonder on 28 Aug 2019
Academics and researchers raise concerns with FDA’s plan for ‘integrated reviews’
28 August 2019 - More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the ...
Posted by Michael Wonder on 28 Aug 2019
FDA warns testing companies: don’t tell patients how their DNA influences response to specific drugs
28 August 2019 - Amid a boom in genetic testing that aims to predict a person’s response to medication, the ...
Posted by Michael Wonder on 27 Aug 2019
DiscGenics receives FDA fast track designation for disc degeneration cell therapy
26 August 2019 - DiscGenics today announced that the U.S. FDA has granted Fast Track designation for its investigational cell ...