Blog
RSS FeedPosted by Michael Wonder on 21 Sep 2021
Covid-19 delta outbreak: major PHARMAC review report delayed by lockdown
22 September 2021 - Act says it is "not good enough" an interim report for a much touted independent PHARMAC ...
Posted by Michael Wonder on 22 Sep 2021
NICE terminates yet another appraisal of daratumumab
22 September 2021 - This is the third terminated appraisal of daratumumab. ...
Posted by Michael Wonder on 22 Sep 2021
TGA approves Leqvio
22 September 2021 - Inclisiran is a cholesterol lowering double-stranded small interfering ribonucleic acid. ...
Posted by Michael Wonder on 22 Sep 2021
Thousands of Australians waiting for 'gamechanger' cystic fibrosis drug
22 September 2021 - Adelaide woman Genevieve Handley has lived with cystic fibrosis all of her life. ...
Posted by Michael Wonder on 21 Sep 2021
Australia eyes Pfizer’s Covid-19 vaccines for kids aged 5 to 11
21 September 2021 - Australian health officials have confirmed if approved the vaccine would be made widely available to children ...
Posted by Michael Wonder on 21 Sep 2021
bluebird bio submits biologics license application to FDA for betibeglogene autotemcel (beti-cel) gene therapy for patients with β-thalassaemia who require regular red blood cell transfusions
21 September 2021 - Biologics license application submission based on data from Phase 1/2 and Phase 3 Northstar studies, which ...
Posted by Michael Wonder on 21 Sep 2021
Inventiva announces FDA decision that fast track designation granted to lanifibranor in NASH encompasses the treatment of NASH with compensated cirrhosis
21 September 2021 - Inventiva today announced that the U.S. FDA has decided that the fast track designation previously granted to ...
Posted by Michael Wonder on 21 Sep 2021
Incyte announces U.S. FDA approval of Opzelura (ruxolitinib) cream, a topical JAK inhibitor, for the treatment of atopic dermatitis
21 September 2021 - Opzelura is the first and only topical Janus kinase inhibitor approved in the United States. ...
Posted by Michael Wonder on 21 Sep 2021
U.S. Food and Drug Administration reasoning in approval decisions when efficacy evidence is borderline (2013–2018)
21 September 2021 - The U.S. FDA has substantial flexibility in its approval criteria in the context of life-threatening disease and ...
Posted by Michael Wonder on 21 Sep 2021
Lilly announces procurement agreement with European Commission to supply bamlanivimab and etesevimab together for the treatment of confirmed COVID-19
21 September 2021 - Joint Procurement Agreement enables European countries to purchase bamlanivimab and etesevimab directly from Lilly, in varying ...
Posted by Michael Wonder on 21 Sep 2021
EU-HTA regulation: methodical preparations for implementation start with IQWiG and G-BA
21 September 2021 - The institute and the G-BA are part of a consortium that is developing the methodological basis ...
Posted by Michael Wonder on 21 Sep 2021
FDA authorises software that can help identify prostate cancer
21 September 2021 - Today, the U.S. FDA authorised marketing of software to assist medical professionals who examine body tissues (pathologists) ...
Posted by Michael Wonder on 21 Sep 2021
FDA approves Lexette for adolescent plaque psoriasis
21 September 2021 - Mayne Pharma is pleased to announce that the U.S. FDA has approved Lexette (halobetasol propionate) foam, ...
Posted by Michael Wonder on 21 Sep 2021
NHS patients gain access to COVID-19 treatment Ronapreve
21 September 2021 - The UK has secured supply of Ronapreve, a new COVID-19 therapeutic developed by Regeneron and Roche ...
Posted by Michael Wonder on 21 Sep 2021
Rhythm Pharmaceuticals completes submission of supplemental new drug application to U.S. Food and Drug Administration for Imcivree (setmelanotide) for the treatment of obesity and control of hunger in Bardet-Biedl and Alström syndromes
20 September 2021 - Rhythm Pharmaceuticals today announced that it has completed its supplemental new drug application to the U.S. FDA ...