Blog
RSS FeedPosted by Michael Wonder on 09 Oct 2020
BioMarin receives FDA approval of label expansion to allow maximum dose of 60 mg for Palynziq (pegvaliase-pqpz) injection for treatment of adults with PKU
7 October 2020 - New safety and efficacy data out to 3 years for first and only enzyme therapy to treat ...
Posted by Michael Wonder on 09 Oct 2020
U.S. FDA grants rare paediatric disease designation to Cerecin’s investigational drug tricaprilin for the treatment of infantile spasms
8 October 2020 - Cerecin announced that the U.S. FDA has granted rare paediatric disease designation to tricaprilin, an investigational drug ...
Posted by Michael Wonder on 09 Oct 2020
X4 Pharmaceuticals announces fast track designation granted by the FDA to mavorixafor for the treatment of WHIM syndrome
8 October 2020 - X4 Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 08 Oct 2020
AstraZeneca vaccine document shows limit of no-profit pledge
8 October 2020 - Company has right under contract to declare pandemic over by July 2021. ...
Posted by Michael Wonder on 08 Oct 2020
Use of real world evidence to support FDA approval of oncology drugs
8 October 2020 - Real world evidence has gained increased attention in recent years as a complement to traditional clinical trials. ...
Posted by Michael Wonder on 08 Oct 2020
CSL confirms UQ vaccine production, trials set for December
8 October 2020 - CSL says it is talking with partner organisations to help roll out doses of the University ...
Posted by Michael Wonder on 08 Oct 2020
Vaccine suppliers given indemnity for 'inevitable' side effects
8 October 2020 - The Morrison government has given the suppliers of two COVID-19 vaccines indemnity against prosecution for rare ...
Posted by Michael Wonder on 08 Oct 2020
Accounting for US public funding in drug development: how can we better balance access, affordability, and innovation?
8 October 2020 - US drug prices are the highest in the world and are continuing to rise, with an increasing ...
Posted by Michael Wonder on 08 Oct 2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved ...
Posted 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 ...