Blog
RSS FeedPosted by Michael Wonder on 01 Nov 2020
The FDA’s Digital Health Center Of Excellence: why it matters and what it means to you
29 October 2020 - Last month, the US FDA launched the Digital Health Center of Excellence, bolstering the shift toward digital ...
Posted by Michael Wonder on 01 Nov 2020
Novartis sickle cell medicine Adakveo approved in Europe to prevent recurrent vaso-occlusive crises
30 October 2020 - Adakveo is the first targeted sickle cell disease therapy for prevention of recurrent vaso-occlusive crises available for ...
Posted by Michael Wonder on 01 Nov 2020
A CDER study of factors that may predict the likelihood of generic drug marketing applications
28 October 2020 - The investigators compiled proprietary data related to abbreviated new drug applications and other internal or public ...
Posted by Michael Wonder on 31 Oct 2020
European Medicines Agency accepts Biogen’s aducanumab marketing authorisation application for Alzheimer's disease
30 October 2020 - If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and ...
Posted by Michael Wonder on 31 Oct 2020
Gilead’s COVID-19 drug is mediocre. It will be a blockbuster anyway.
29 October 2020 - Gilead Sciences said Wednesday that remdesivir, which has been authorised for emergency use since the spring, brought ...
Posted by Michael Wonder on 31 Oct 2020
Social media disinformation campaigns tied to vaccine hesitancy
29 October 2020 - Social media disinformation campaigns designed to cast doubt on the safety and effectiveness of vaccines are contributing ...
Posted by Michael Wonder on 31 Oct 2020
Extra transparency measures for COVID-19 vaccines and therapeutics
30 October 2020 - Today the EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing both ...
Posted by Michael Wonder on 30 Oct 2020
How will a COVID vaccine be distributed once it's approved by FDA?
29 October 2020 - Distributing the first wave of doses will be a massive undertaking. ...
Posted by Michael Wonder on 29 Oct 2020
European Patent Office rules in favour of Sanofi and Regeneron concerning Praluent (alirocumab)
29 October 2020 - Ruling invalidates Amgen’s European patent claims directed to PCSK9 antibodies relevant to Praluent (alirocumab). ...
Posted by Michael Wonder on 29 Oct 2020
The FDA will not inspect vaccine production plants
29 October 2020 - Approval of a vaccine by the FDA typically requires inspection of the vaccine’s manufacturing plants. ...
Posted by Michael Wonder on 29 Oct 2020
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
29 October 2020 - The new FDA approval allows the test to be used as a companion diagnostic for a broad ...
Posted by Michael Wonder on 29 Oct 2020
FDA accepts for priority review Libtayo (cemiplimab-rwlc) for advanced non-small cell lung cancer with PD-L1 expression of ≥50%
29 October 2020 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the supplemental biologics license ...
Posted by Michael Wonder on 29 Oct 2020
European Commission grants marketing authorisation for Arikayce liposomal 590 mg nebuliser dispersion for the treatment of NTM lung infections caused by MAC in adult non-CF patients with limited treatment options
28 October 2020 - Arikayce is the first and only therapy approved in both the European Union and United States for ...
Posted by Michael Wonder on 29 Oct 2020
reVision Therapeutics announces US FDA grant of rare paediatric disease and orphan drug designation for REV-0100 for the treatment of Stargardt disease
28 October 2020 - reVision Therapeutics today announced that the US FDA has granted the Company's request to designate REV-0100 as ...
Posted by Michael Wonder on 29 Oct 2020
Passage Bio’s PBKR03 receives orphan drug and rare paediatric disease designations from FDA for treatment of Krabbe disease
28 October 2020 - Passage Bio today announced that the U.S. FDA has granted orphan drug and rare paediatric disease designations ...