Blog
RSS FeedPosted by Michael Wonder on 29 Mar 2021
GSK receives CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis
26 March 2021 - GlaxoSmithKline today announced the CHMP of the EMA has adopted a positive opinion recommending the use of ...
Posted by Michael Wonder on 29 Mar 2021
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat people with cystic fibrosis with at least one F508del mutation
26 March 2021 - If approved, people ages 12 years and older who have one copy of the F508del mutation and ...
Posted by Michael Wonder on 29 Mar 2021
Amazon gets emergency FDA approval for at-home COVID-19 test kit
26 March 2021 - Amazon on Friday received emergency use authorisation from the FDA for an at-home COVID-19 testing kit that ...
Posted by Michael Wonder on 29 Mar 2021
Mezzion announces resubmission of new drug application for its orphan drug udenafil to treat patients who have undergone the Fontan operation for single ventricle heart disease
28 March 2021 - Submitted for FDA priority review as a rare paediatric disease product application. ...
Posted by Michael Wonder on 29 Mar 2021
Building a more robust medicine supply - proposals to help prevent, mitigate and manage medicine shortages
29 March 2021 - The Therapeutic Goods Administration is conducting a public consultation seeking feedback on reforms intended to help ...
Posted by Michael Wonder on 28 Mar 2021
Astellas receives positive CHMP opinion for Xtandi (enzalutamide) for patients with metastatic hormone-sensitive prostate cancer
26 March 2021 - If approved by the European Commission, enzalutamide will be the only oral therapy for the treatment of ...
Posted by Michael Wonder on 27 Mar 2021
FDA approves first cell-based gene therapy for adult patients with multiple myeloma
27 March 2021 - The U.S. FDA approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple ...
Posted by Michael Wonder on 26 Mar 2021
Highlights from the CHMP 22-25 March 2022 meeting
26 March 2021 - EMA’s CHMP recommended five medicines for approval at its March 2021 meeting. ...
Posted by Michael Wonder on 26 Mar 2021
Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
26 March 2021 - EMA’s CHMP has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines ...
Posted by Michael Wonder on 26 Mar 2021
FDA authorises marketing of device to improve gait in multiple sclerosis patients
26 March 2021 - Today, the U.S. FDA authorised marketing of a new device indicated for use as a short-term treatment ...
Posted by Michael Wonder on 26 Mar 2021
FDA approves first in the world device to treat patients with congenital heart disease
26 March 2021 - New implant device provides less invasive option to treat pulmonary valve regurgitation for patients with a native ...
Posted by Michael Wonder on 26 Mar 2021
European Medicines Agency accepts marketing authorisation application for enfortumab vedotin
26 March 2021 - Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial ...
Posted by Michael Wonder on 26 Mar 2021
Europe slams the brakes on vaccine exports until its needs are met
26 March 2021 - Europe has stepped back from its threat to seize AstraZeneca factories or enact a full vaccine ...
Posted by Michael Wonder on 26 Mar 2021
Takeda begins regulatory submissions for dengue vaccine candidate in EU and Dengue-endemic countries
26 March 2021 - EMA to conduct first-ever parallel assessment of a medicinal product, Takeda’s dengue vaccine candidate (TAK-003), for use ...
Posted by Michael Wonder on 26 Mar 2021
Attacks on AstraZeneca cast doubt over its vaccine pricing, says top scientist
26 March 2021 - The EU’s attacks on AstraZeneca call into question the company’s decision not to profit from its ...