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RSS FeedPosted 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
La Jolla Pharmaceutical receives European Commission approval for Giapreza (angiotensin II)
29 August 2019 - La Jolla Pharmaceutical Company today announced that the European Commission has approved Giapreza (angiotensin II) for ...
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
EMA offers edits on FDA draft guidance on biosimilars
29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late ...
Posted by Michael Wonder on 29 Aug 2019
European Commission approves Roche’s Tecentriq in combination with Abraxane for people with PD-L1-positive, metastatic triple-negative breast cancer
29 August 2019 - Approval based on the Phase III IMpassion130 study, which showed that the combination improved outcomes in people ...
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
‘Nobody can afford this’: family left helpless after Health Canada approves official version of prescription eye drops
28 August 2019 - From the time she was diagnosed with an ultra-rare metabolic disorder as a toddler, Olivia Little ...
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 ...