Blog
RSS FeedPosted 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
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 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 ...
Posted by Michael Wonder on 14 Jul 2020
Verrica Pharmaceuticals receives complete response letter from the FDA for its new drug application for VP-102 for the treatment of molluscum contagiosum
14 July 2020 - Complete response letter requests additional chemistry, manufacturing, and controls and human factors information. ...
Posted by Michael Wonder on 14 Jul 2020
Teva announces availability of ProAir Digihaler (salbutamol sulphate 117 mcg) inhalation powder for patients with asthma and COPD
13 July 2020 - First and only digital rescue inhaler with built-in sensors now available by prescription to patients in the ...
Posted by Michael Wonder on 13 Jul 2020
FDA advises CytoDyn its application is incomplete
13 July 2020 - CytoDyn announced today it has received a refusal to file letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 13 Jul 2020
Pfizer and BioNTech granted FDA fast track designation for two investigational mRNA-based vaccine candidates against SARS-CoV-2
13 July 2020 - Anticipated large, global Phase 2b/3 safety and efficacy study may begin as early as July 2020. ...
Posted by Michael Wonder on 13 Jul 2020
Ipsen announces updated indication for Dysport (abobotulinumtoxinA) for the treatment of spasticity in children
10 July 2020 - Dysport is now FDA approved to treat both upper and lower limb spasticity in paediatric patients two ...
Posted by Michael Wonder on 12 Jul 2020
COVID-19 is forcing us to rethink clinical trials for cancer treatments
9 July 2020 - Participation rates were already low, but the pandemic threatens to drive them even lower. ...
Posted by Michael Wonder on 12 Jul 2020
Remdesivir: US purchase of world stocks sparks new “hunger games,” warn observers
3 July 2020 - The US has bought up almost all the world’s supply of the antiviral drug remdesivir in ...
Posted by Michael Wonder on 10 Jul 2020
FDA approves expanded Botox (onabotulinumtoxinA) label for the treatment of paediatric patients with spasticity
9 July 2020 - Updated label now includes paediatric patients with lower limb spasticity caused by cerebral palsy. ...
Posted by Michael Wonder on 10 Jul 2020
Leo Pharma announces U.S. FDA acceptance of biologics license application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis
9 July 2020 - Submission includes data from pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies evaluating safety and ...