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RSS FeedPosted by Michael Wonder on 05 Apr 2024
Public summary documents – December 2023 PBAC meeting
5 April 2024 - The public summary documents (positive recommendations and subsequent decisions not to recommend) from the December 2023 PBAC ...
Posted by Michael Wonder on 05 Apr 2024
Bausch Health Canada announces first public drug plan listings for Uceris (budesonide) aerosol foam to help address the unmet need for the treatment of mild to moderate distal ulcerative colitis in adults
3 April 2024 - Bausch Health Canada today announced the first public drug plan listings for Uceris (budesonide) aerosol foam ...
Posted by Michael Wonder on 04 Apr 2024
Amylyx Pharmaceuticals announces formal intention to remove Relyvrio/Albrioza from the market
4 April 2024 - Based on top-line results from the Phase 3 PHOENIX trial of AMX0035 in ALS, Amylyx has started ...
Posted by Michael Wonder on 04 Apr 2024
New model validation tool to support economic evaluations of health technologies
1 April 2024 - CADTH has developed a comprehensive and accessible tool to support the validation of economic models used in ...
Posted by Michael Wonder on 04 Apr 2024
Medicare coverage of weight loss drugs could save the US billions of dollars
3 April 2024 - The latest weight loss drugs are good. Really good. They can save lives and could literally remake ...
Posted by Michael Wonder on 04 Apr 2024
FDA accepts supplemental biologics license applications for Bimzelx (bimekizumab-bkzx) for moderate to severe hidradenitis suppurativa and additional 2 mL device presentations
4 April 2024 - Application in moderate to severe hidradenitis suppurativa based on results from two Phase 3 studies where ...
Posted by Michael Wonder on 04 Apr 2024
Vanda Pharmaceuticals' Fanapt (iloperidone) receives US FDA approval for the acute treatment of bipolar I disorder
2 April 2024 - Fanapt treatment is now available to adult patients for the acute treatment of manic or mixed episodes ...
Posted by Michael Wonder on 03 Apr 2024
FDA approves new antibiotic for three different uses
3 April 2024 - Today, the US FDA approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with ...
Posted by Michael Wonder on 03 Apr 2024
RemeGen's telitacicept (RC18) granted fast track designation by US FDA for treatment of primary Sjögren's syndrome
2 April 2024 - RemeGen has obtained fast track designation by the US FDA recently for its innovative BLyS/APRIL dual-target ...
Posted by Michael Wonder on 03 Apr 2024
Agenda for the July 2024 PBAC meeting
3 April 2024 - The agenda for the July 2024 PBAC meeting is now available. ...
Posted by Michael Wonder on 03 Apr 2024
Zanidatamab biologics license application for previously treated HER2 positive metastatic biliary tract cancer completed
2 April 2024 - Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, completion of the rolling submission of ...
Posted by Michael Wonder on 03 Apr 2024
Dostarlimab in combination with platinum-based chemotherapy for the treatment of patients with advanced or recurrent, high microsatellite instability or mismatch repair deficiency endometrial cancer
3 April 2024 - NICE has published final evidence-based recommendations on the use of dostarlimab (Jemperli) in combination with platinum-based ...
Posted by Michael Wonder on 03 Apr 2024
European Commission expands approval of Bristol Myers Squibb’s Reblozyl (luspatercept) to include first-line treatment of transfusion-dependent anaemia in adults with lower-risk myelodysplastic syndromes
2 April 2024 - Approval of Reblozyl is based on head-to-head, pivotal Phase 3 COMMANDS study, in which Reblozyl nearly doubled ...
Posted by Michael Wonder on 02 Apr 2024
TME Pharma receives US FDA fast track designation for lead asset NOX-A12 in brain cancer
2 April 2024 - Fast track designation for NOX-A12 follows recently announced FDA clearance of investigational new drug application for Phase ...
Posted by Michael Wonder on 02 Apr 2024
Polatuzumab vedotin in untreated diffuse large B-cell lymphoma: one step forward, two steps back
2 April 2024 - Roche designed its trial for both approval and health technology assessments but the analyses planned for ...