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 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. ...
Posted by Michael Wonder on 19 Jul 2024
Orexo shares new information on OX124, a high dose naloxone rescue medication in development for opioid overdose
16 July 2024 - Orexo today announces that the company has received a complete response letter from the US FDA regarding ...
Posted by Michael Wonder on 18 Jul 2024
BC doctor calls on the province to cover obesity medications
17 July 2024 - A petition from Dr. Ali Zentner asking for more PharmaCare coverage has received almost 1,000 signatures. ...
Posted by Michael Wonder on 18 Jul 2024
Junshi Biosciences announces the acceptance of the supplemental new drug application for toripalimab combined with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma
17 July 2024 - Shanghai Junshi Biosciences announced that the National Medical Products Administration has accepted for review the supplemental new ...
Posted by Michael Wonder on 18 Jul 2024
Transparent and complete reporting of surrogate endpoints in trials: the SPIRIT-Surrogate and CONSORT-Surrogate extensions
11 July 2024 - Randomised trials are resource-intensive studies that provide robust evidence for evaluating the effectiveness of interventions. ...
Posted by Michael Wonder on 18 Jul 2024
Rucaparib camsylate for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy
8 July 2024 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...
Posted by Michael Wonder on 18 Jul 2024
Teclistamab for the treatment of patients with relapsed and refractory multiple myeloma after three or more treatments (review of previous guidance)
16 July 2024 - The Department of Health and Social Care has asked the NICE to review the guidance on ...
Posted by Michael Wonder on 18 Jul 2024
Zilbrysq (zilucoplan injection) now approved for adults with generalised myasthenia gravis in Canada
17 July 2024 - Health Canada's approval is supported by the pivotal Phase 3 RAISE study in generalised myasthenia gravis in adult ...
Posted by Michael Wonder on 18 Jul 2024
Diakonos Oncology receives FDA fast track designation for pancreatic cancer dendritic cell vaccine
15 July 2024 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the company’s unique ...