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RSS FeedPosted by Michael Wonder on 24 Jun 2022
BioNTech Receives Priority Medicines (PRIME) designation from EMA for enhanced regulatory support of CAR-T candidate BNT211 in testicular cancer
23 June 2022 - Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs ...
Posted by Michael Wonder on 08 Jun 2022
Allogene Therapeutics announces the FDA granted regenerative medicine advanced therapy designation to ALLO-501A for large B-cell Lymphoma
8 June 2022 - In the ALPHA trials with ALLO-501 and ALLO-501A, treatment was initiated approximately 2 days from enrollment, eliminating ...
Posted by Michael Wonder on 08 Jun 2022
MHRA gives Alnylam ‘innovation passport’ for hypertension drug zilebesiran
8 June 2022 - The UK medicines regulator has awarded Alnylam’s RNAi based therapy zilebesiran for hypertension an ‘innovation passport‘, ...
Posted by Michael Wonder on 08 Jun 2022
Vertex announces inaxaplin (VX-147) granted breakthrough therapy designation by U.S. FDA and PRIME designation by the EMA
8 June 2022 - Vertex granted nine breakthrough therapy designations and three PRIME designations across its pipeline programs to date. ...
Posted by Michael Wonder on 06 Jun 2022
GBT’s inclacumab and GBT601 receive U.S. FDA orphan drug and rare paediatric disease designations for the treatment of sickle cell disease
6 June 2022 - Inclacumab is a novel P selectin inhibitor currently in Phase 3 clinical trials to reduce vaso-occlusive ...
Posted by Michael Wonder on 31 May 2022
Y-mAbs Announces FDA acceptance of biologics license application for Omblastys (omburtamab) for the treatment of neuroblastoma for priority review
31 May 2022 - Y-mAbs Therapeutics today announced that the biologics license application for Omblasyts (omburtamab) for the treatment of paediatric ...
Posted by Michael Wonder on 26 May 2022
Reata Pharmaceuticals announces FDA filing acceptance and priority review designation for the NDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia
26 May 2022 - Application assigned a PDUFA date of 30 November 2022. ...
Posted by Michael Wonder on 25 May 2022
Noveome Biotherapeutics receives rare paediatric disease designation and orphan drug designation for the treatment of necrotising enterocolitis in neonates
24 May 2022 - Noveome Biotherapeutics today announced that the U.S. FDA has granted rare paediatric disease designation and orphan drug ...
Posted by Michael Wonder on 24 May 2022
FDA accepts CSL Behring's biologics license application for etranacogene dezaparvovec for priority review
24 May 2022 - If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with haemophilia B. ...
Posted by Michael Wonder on 24 May 2022
Neuronascent receives FDA rare paediatric drug designation for NNI-351 treatment for Fragile X syndrome
24 May 2022 - Neuronascent today announced that the US FDA granted rare paediatric designation for NNI-351 for Fragile X ...
Posted by Michael Wonder on 24 May 2022
ImmunoGen announces acceptance of biologics license application for mirvetuximab soravtansine in ovarian cancer by US Food and Drug Administration with priority review
23 May 2022 - PDUFA date is 28 November 2022. ...
Posted by Michael Wonder on 16 May 2022
Travere Therapeutics announces FDA acceptance and priority review of new drug application for sparsentan for the treatment of IgA nephropathy
16 May 2022 - PDUFA target action date of 17 November 2022. ...
Posted by Michael Wonder on 14 May 2022
Bridgebio Pharma sells rare pediatric disease priority review voucher for $110 million
13 May 2022 - Entered into a definitive agreement to sell the rare paediatric disease priority review voucher it obtained in ...
Posted by Michael Wonder on 13 May 2022
PolarityTE announces FDA regenerative medicine advanced therapy designation granted to SkinTE
13 May 2022 - PolarityTE today announced that the U.S. FDA granted a regenerative medicine advanced therapy designation to SkinTE under ...
Posted by Michael Wonder on 04 May 2022
Imfinzi plus chemotherapy granted priority review in the US for patients with locally advanced or metastatic biliary tract cancer based on TOPAZ-1 Phase III trial
4 May 2022 - First Phase 3 trial in this setting to show improved overall survival with an immunotherapy added ...