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RSS FeedPosted by Michael Wonder on 10 Oct 2020
Pfizer Canada and BioNTech initiate rolling submission to Health Canada for SARS-CoV-2 vaccine candidate BNT162b2
9 October 2020 - Pfizer Canada and BioNTech will continue regular and open dialogue with Health Canada providing results from their ...
Posted by Michael Wonder on 09 Oct 2020
Italfarmaco receives FDA rare paediatric disease designation for givinostat in Duchenne muscular dystrophy, announces completed enrolment in EPIDYS Phase 3 trial
9 October 2020 - The Italfarmaco Group provided today an update on the development of givinostat, its proprietary histone deacetylase ...
Posted by Michael Wonder on 09 Oct 2020
NDA filing for Luye Pharma’s anti-depressant drug LY03005 accepted by the U.S. FDA
4 March 2020 - Luye Pharma Group has announced that the U.S. FDA has reviewed and accepted the filing of ...
Posted by Michael Wonder on 09 Oct 2020
New transparency measures for prescription medicines
9 October 2020 - The Australian Government has given approval to proceed with two measures to enhance transparency for prescription ...
Posted by Michael Wonder on 09 Oct 2020
Eton Pharmaceuticals announces acceptance for filing of new drug application for orphan drug dehydrated alcohol injection
8 October 2020 - Application assigned a PDUFA date of 27 May 2021. ...
Posted by Michael Wonder on 09 Oct 2020
MHRA to join Project Orbis
8 October 2020 - The UK is set to join the US FDA's Project Orbis at the start of next ...
Posted by Michael Wonder on 09 Oct 2020
Johnson & Johnson announces European Commission approval of agreement to supply 200 million doses of Janssen’s COVID-19 vaccine candidate
8 October 2020 - Agreement provides option for European Union Member States to secure up to 200 million additional doses for ...
Posted 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 ...