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RSS FeedPosted by Michael Wonder on 08 Oct 2020
Regeneron asks FDA for emergency approval for drug that Trump claimed cured him
7 October 2020 - The company said that doses of the unproven treatment would be available for 50,000 patients. It’s impossible ...
Posted by Michael Wonder on 08 Oct 2020
Gilead inks supply agreement with the European Commission for remdesivir
8 October 2020 - Gilead has signed a joint procurement agreement with the European Commission to enable ‘rapid and equitable’ ...
Posted by Michael Wonder on 08 Oct 2020
Y-mAbs’ nivatrotamab for the treatment of patients with neuroblastoma granted orphan drug designation and rare paediatric disease designation by FDA
7 October 2020 - Y-mAbs Therapeutics today announced that the FDA has granted orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 08 Oct 2020
Australian Government finalises University of Queensland-CSL COVID-19 vaccine agreement
8 October 2020 - The Australian Government is investing a total of $2.3 billion to support home-grown researchers and manufacturers to ...
Posted by Michael Wonder on 08 Oct 2020
NDA submission for Polarean’s hyperpolarised 129 Xenon gas drug-device diagnostic for lung imaging
7 October 2020 - Polarean Imaging announces its submission of a new drug application and request for priority review to the ...
Posted by Michael Wonder on 08 Oct 2020
To maintain trust and respectability, digital health companies must commit to the highest standards
7 October 2020 - The digital health gold rush is on. Teledoc’s $18.5 billion acquisition of Livongo reflects the valuation ...
Posted by Michael Wonder on 08 Oct 2020
Health Canada approves Zeposia, an oral treatment for relapsing remitting multiple sclerosis
7 October 2020 - Bristol Myers Squibb's medication provides a new oral treatment option for Canadians living with the neurological disease. ...
Posted by Michael Wonder on 07 Oct 2020
European countries face shortages of COVID-19 drug remdesivir
7 October 2020 - European countries are facing shortages of COVID-19 drug remdesivir because limited supplies are running out, officials said, ...
Posted by Michael Wonder on 07 Oct 2020
New online platform for scientific advice
7 October 2020 - From 19 October 2020, developers of human or veterinary medicines should use EMA’s IRIS Regulatory & ...
Posted by Michael Wonder on 07 Oct 2020
Eli Lilly asks FDA to authorise COVID-19 antibody drug
7 October 2020 - Company says it could supply one million doses of the treatment this year, if regulator authorises emergency ...
Posted by Michael Wonder on 07 Oct 2020
FDA issues guidance on Emergency Use Authorisation for COVID-19 vaccines
6 October 2020 - Today, the U.S. FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and ...
Posted by Michael Wonder on 07 Oct 2020
Eton Pharmaceuticals submits new drug application to the FDA for topiramate oral solution
6 October 2020 - Application submitted for the treatment of partial-onset seizures and migraine. ...
Posted by Michael Wonder on 07 Oct 2020
Santhera to discontinue Phase 3 SIDEROS trial and development of Puldysa in Duchenne muscular dystrophy and focus on vamorolone
6 October 2020 - As a consequence, Santhera will discontinue the study, withdraw the European marketing authorization application and end the ...
Posted by Michael Wonder on 07 Oct 2020
Oncternal Therapeutics receives rare paediatric disease designation from U.S. FDA for TK216 for treatment of Ewing sarcoma
6 October 2020 - Oncternal Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for TK216, an ...
Posted by Michael Wonder on 07 Oct 2020
Aegle Therapeutics receives rare paediatric disease designation from the FDA for AGLE-102 for patients with dystrophic epidermolysis bullosa
6 October 2020 - -- Aegle Therapeutics today announced that the FDA has granted rare paediatric disease designation to ...