Blog
RSS FeedPosted by Michael Wonder on 19 Jul 2024
Johnson & Johnson, BMS fight US drug price plan at Third Circuit
16 July 2024 - Pharmaceutical giants Johnson & Johnson, BMS and AstraZeneca are rejecting federal district court decisions that rule ...
Posted by Michael Wonder on 20 Jul 2024
Neuren receives rare paediatric disease designation from FDA
19 July 2024 - Neuren Pharmaceuticals has received rare paediatric disease designation from the US FDA for NNZ-2591 in Phelan-McDermid ...
Posted by Michael Wonder on 20 Jul 2024
EMA accepts Deciphera’s marketing authorisation application for vimseltinib for treatment of patients with tenosynovial giant cell tumour
18 July 2024 - Application based on results from the MOTION Phase 3 study, in which vimseltinib demonstrated statistically significant and ...
Posted by Michael Wonder on 20 Jul 2024
Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the EMA
19 July 2024 - Regulatory submission supported by Phase 3 head to head DREAMM-7 and DREAMM-8 trials. ...
Posted by Michael Wonder on 19 Jul 2024
Bristol Myers Squibb receives EMA validation of application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of unresectable or advanced hepatocellular carcinoma
19 July 2024 - The Application is based on Phase 3 CheckMate-9DW trial results demonstrating improved survival with Opdivo plus ...
Posted by Michael Wonder on 19 Jul 2024
Phathom Pharmaceuticals announces FDA approval of Voquenza (vonoprazan) tablets for the relief of heartburn associated with non-erosive GERD in adults
18 July 2024 - Voquenza met its primary endpoint in its Phase 3 pivotal trial by demonstrating a significant and rapid ...
Posted by Michael Wonder on 19 Jul 2024
Lexicon Pharmaceuticals receives 20 December 2024 PDUFA goal date for sotagliflozin type 1 diabetes NDA resubmission
16 July 2024 - Launch preparations actively underway; launch planned for early 2025. ...
Posted by Michael Wonder on 19 Jul 2024
More than 40,000 people could benefit after NICE recommends new ‘take at home’ pill for advanced prostate cancer
19 July 2024 - A new pill to treat advanced hormone sensitive prostate cancer that could benefit just over 40,000 ...
Posted by Michael Wonder on 19 Jul 2024
Public Summary Documents (first time decisions not to recommend and deferrals) - March 2024 PBAC meeting
19 July 2024 - The Public Summary Documents (first time decisions not to recommend and deferrals) from the March 2024 ...
Posted by Michael Wonder on 19 Jul 2024
DUSC utilisation analysis public release documents (June 2024)
19 July 2024 - The utilisation analysis public release documents from the June 2024 DUSC meeting are now available. ...
Posted by Michael Wonder on 19 Jul 2024
Outcome statement - June 2024 DUSC meeting
19 July 2024 - The outcome statement from the June 2024 DUSC meeting is now available. ...
Posted by Michael Wonder on 19 Jul 2024
PHARMAC proposes to widen access to urinary tract infections treatment and fund a new epilepsy treatment
18 July 2024 - PHARMAC is consulting on improving access to treatment for urinary tract infections, as well as providing ...
Posted by Michael Wonder on 19 Jul 2024
Bavarian Nordic receives EMA filing acceptance and validation of the MAA for its chikungunya vaccine
18 July 2024 - EMA will now initiate its centralised review procedure under accelerated assessment for Bavarian Nordic’s chikungunya vaccine. ...
Posted by Michael Wonder on 19 Jul 2024
Diamyd Medical receives second US FDA fast track designation for Diamyd - for the prevention of type 1 diabetes
18 July 2024 - Diamyd Medical announced today that the US FDA has granted fast track designation for Diamyd (rhGAD65/alum) to ...
Posted by Michael Wonder on 19 Jul 2024
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
17 July 2024 - PDUFA target action date of 15 January 2025. ...