Blog
RSS FeedPosted by Michael Wonder on 17 Jul 2020
MC2 Therapeutics announces submission of marketing authorisation application in EU for Wynzora cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate))
16 July 2020 - MC2 Therapeutics today announced the submission of its marketing authorisation application in EU for Wynzora cream (50 ...
Posted by Michael Wonder on 17 Jul 2020
Xenleta (lefamulin) receives Health Canada approval for treatment of community acquired pneumonia
16 July 2020 - Nabriva Therapeutics announced today that its partner, Sunovion Pharmaceuticals, has received approval from Health Canada to market ...
Posted by Michael Wonder on 16 Jul 2020
Farxiga granted fast track designation in the US for heart failure following acute myocardial infarction leveraging an innovative registry-based trial design
16 July 2020 - Phase III DAPA-MI trial will evaluate Farxiga as a treatment to reduce mortality and the risk of ...
Posted by Michael Wonder on 16 Jul 2020
Actual and potential harm caused by medical software
16 July 2020 - TGA publishes a rapid literature review of safety and performance issues. ...
Posted by Michael Wonder on 16 Jul 2020
Hanmi’s fatty liver drug won FDA’s fast track designation
16 July 2020 - Hanmi Pharmaceutical said Thursday that the U.S. FDA has granted fast-track designation to its LAPSTriple Agonist ...
Posted by Michael Wonder on 16 Jul 2020
Deep dive into big pharma AI productivity: one study shaking the pharmaceutical industry
15 July 2020 - The pharmaceutical business is perhaps the only industry on the planet, where to get the product from ...
Posted by Michael Wonder on 16 Jul 2020
FDA grants priority review to Merck’s new drug application for vericiguat
16 July 2020 - Application based on first contemporary outcomes study focused exclusively on chronic heart failure patient population following a ...
Posted by Michael Wonder on 16 Jul 2020
European Commission approves third nintedanib indication in pulmonary fibrosis
15 July 2020 - The approval is for the treatment of adults with other chronic fibrosing interstitial lung diseases with a ...
Posted by Michael Wonder on 16 Jul 2020
Knopp Biosciences receives rare paediatric disease designation for Kv7 activator KB-3061 for treatment of KCNQ2 epileptic encephalopathy
15 July 2020 - Knopp Biosciences announced today that it has received rare paediatric disease designation from the U.S. FDA ...
Posted by Michael Wonder on 15 Jul 2020
Improving clinical trial enrollment — In the COVID-19 era and beyond
15 July 2020 - More than 3 million people in the United States are known to have been infected with SARS-CoV-2. ...
Posted by Michael Wonder on 15 Jul 2020
The COVID-19 vaccine development multiverse
14 July 2020 - Leaving in its wake more than 12 million infections, over 550,000 deaths, and an economic toll in ...
Posted by Michael Wonder on 15 Jul 2020
FDA grants breakthrough therapy designation for Roche's CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma
14 July 2020 - Tenth breakthrough therapy designation awarded for Roche's haematology medicines. ...
Posted by Michael Wonder on 15 Jul 2020
Deciphera announces Australian Therapeutic Goods Administration’s approval of Qinlock (ripretinib) for the treatment of fourth-line gastro-intestinal stromal tumour
14 July 2020 - Qinlock is the first approved tyrosine kinase inhibitor designed specifically for GIST regardless of patients’ mutational status. ...
Posted by Michael Wonder on 14 Jul 2020
Gilead rushes to meet remdesivir demand as virus pressures grow
15 July 2020 - Global pharmaceuticals giant Gilead has flagged the supply of its coronavirus treatment remdesivir will be constrained ...
Posted by Michael Wonder on 14 Jul 2020
Tremfya (guselkumab) approved by U.S. Food and Drug Administration as the first selective interleukin-23 inhibitor for active psoriatic arthritis
14 July 2020 - In two Phase 3 clinical trials, Tremfya significantly improved signs and symptoms in joints, skin and soft ...