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RSS FeedPosted by Michael Wonder on 12 Mar 2020
Law makers pressure big pharma on drug supply chains amid coronavirus outbreak
11 March 2020 - Law makers have for years been concerned the U.S. is too reliant on foreign manufacturing of medicine. ...
Posted by Michael Wonder on 12 Mar 2020
Acacia Pharma announces brief extension of FDA review period for NDA for Byfavo, an ultra-short acting and reversible anesthetic for procedural sedation
12 March 2020 - Acacia Pharma announces that the US FDA has extended the review period for the new drug ...
Posted by Michael Wonder on 12 Mar 2020
US FDA grants fast track designation to Jardiance for the treatment of chronic kidney disease
12 March 2020 - FDA fast track designation is for the investigation of potential new therapies that treat serious conditions and ...
Posted by Michael Wonder on 12 Mar 2020
RadioMedix and Curium Announce copper Cu 64 dotatate injection was granted priority review by the U.S. FDA
11 March 2020 - RadioMedix and its commercial partner Curium announced the U.S. FDA has granted copper Cu 64 dotatate injection ...
Posted by Michael Wonder on 11 Mar 2020
Janssen announces U.S. FDA breakthrough therapy designation granted for JNJ-6372 for the treatment of non-small cell lung cancer
10 March 2020 - JNJ-6372, a dual-targeting EGFR-MET bispecific antibody, is being investigated for adults with non-small cell lung cancer EGFR ...
Posted by Michael Wonder on 11 Mar 2020
U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) for patients with hepatocellular carcinoma previously treated with sorafenib
11 March 2020 - Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting. ...
Posted by Michael Wonder on 11 Mar 2020
Daré Bioscience receives FDA fast track designation for DARE-BV1 for the treatment of bacterial vaginosis
10 March 2020 - DARE-BV1 demonstrated an 86% clinical cure rate in evaluable subjects at the test-of-cure visit after a single ...
Posted by Michael Wonder on 10 Mar 2020
Inappropriate use of progression-free survival in cancer drug approvals
10 March 2020 - New drugs should be judged on overall survival or quality of life, preferably both. ...
Posted by Michael Wonder on 10 Mar 2020
Coronavirus disease 2019 (COVID-19) update: foreign inspections
10 March 2020 - Today, we are providing an update on the status of U.S. FDA inspections outside of the U.S. ...
Posted by Michael Wonder on 09 Mar 2020
FDA proposes broad approach for conducting safety trials for type 2 diabetes medications
9 March 2020 - The U.S. FDA today issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety ...
Posted by Michael Wonder on 09 Mar 2020
FDA approves first treatment for group of progressive interstitial lung diseases
9 March 2020 - The U.S. FDA today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing interstitial lung ...
Posted by Michael Wonder on 09 Mar 2020
Athenex announces FDA acceptance for filing of U.S. NDA for tirbanibulin ointment in actinic keratosis
9 March 2020 - PDUFA date of 30 December 2020. ...
Posted by Michael Wonder on 09 Mar 2020
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar bevacizumab for review
9 March 2020 - Biocon and Mylan today announced that the U.S. FDA has accepted Mylan’s biologics license application for ...
Posted by Michael Wonder on 09 Mar 2020
Regulating medicines in a globalised world with increased recognition and reliance among regulators
5 March 2020 - Research and development of pharmaceuticals are now complex global endeavours, with drug companies operating worldwide using global ...
Posted by Michael Wonder on 08 Mar 2020
Five years on, biosimilars need support from all health care players
6 March 2020 - Today marks a milestone for the U.S. biosimilar market: the FDA approved our first biosimilar, Sandoz’s ...