Blog
RSS FeedPosted by Michael Wonder on 03 May 2024
Improved deal signals NICE recommendation of sickle cell treatment voxelotor
3 May 2024 - Around 4,000 people with sickle cell disease could benefit from a new treatment recommended by NICE ...
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
MSAC publishes agenda for 1-2 August 2024 MSAC meeting
3 April 2024 - The MSAC Secretariat has published a list of applications scheduled to be considered by the MSAC ...
Posted by Michael Wonder on 03 Apr 2024
Autolus Therapeutics announces acceptance of marketing authorisation application by the EMA for obecabtagene autoleucel for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
2 April 2024 - Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL. ...
Posted by Michael Wonder on 03 Apr 2024
Vertex announces new drug submission for exagamglogene autotemcel (exa-cel) has been accepted for priority review by Health Canada for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
1 April 2024 - Exa-cel is the first CRISPR-based gene-edited therapy to be submitted for Health Canada review. ...
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
Solid Biosciences receives rare paediatric disease designation from the FDA for Duchenne muscular dystrophy gene therapy candidate SGT-003
1 April 2024 - Site initiations scheduled for April; patient dosing expected to begin in Q2 ,2024. ...
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 ...
Posted by Michael Wonder on 02 Apr 2024
Joe Biden’s assault on the $900 child eczema cream
2 April 2024 - What the Inflation Reduction Act means for the cost of health care. ...
Posted by Michael Wonder on 02 Apr 2024
Mirum Pharmaceuticals’ Livmarli (maralixibat oral solution) receives positive reimbursement recommendation by Canada’s CADTH for patients with cholestatic pruritus in Alagille syndrome
2 April 2024 - Positive HTA recommendation for reimbursement signifies an important milestone towards public funding to treat eligible patients with ...