Blog
RSS FeedPosted 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
Sellas announces US FDA rare paediatric disease designation granted to SLS009 for the treatment of paediatric acute myeloid leukaemia
16 July 2024 - Opened enrollment for paediatric AML patients in on-going Phase 2 clinical trial. ...
Posted by Michael Wonder on 17 Jul 2024
ICER releases draft evidence report on treatments for transthyretin amyloid cardiomyopathy
17 July 2024 - Public comment period now open until 13 August 2024; requests to make oral comment during public ...
Posted by Michael Wonder on 17 Jul 2024
Longeveron announces US FDA grants fast track designation for Lomecel-B for the treatment of mild Alzheimer’s disease
17 July 2024 - Second designation received for Lomecel-B for the treatment of mild Alzheimer’s disease after regenerative medicine advanced therapeutics ...
Posted by Michael Wonder on 17 Jul 2024
Ocrelizumab approved as an injection to treat multiple sclerosis in adults
12 July 2024 - The MHRA has approved a new formulation of the medicine ocrelizumab (Ocrevus 920 mg solution for injection) ...
Posted by Michael Wonder on 17 Jul 2024
Health Canada authorizes Alecensaro (alectinib) as the first and only adjuvant treatment for people with ALK positive early stage lung cancer
16 July 2024 - Alecensaro reduced the risk of disease recurrence or death by 76% in people with ALK positive resected ...
Posted by Michael Wonder on 17 Jul 2024
The Biden-Harris Administration releases final Part Two guidance to help people with Medicare prescription drug coverage manage prescription drug costs
16 July 2024 - The Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (CMS), continues ...
Posted by Michael Wonder on 16 Jul 2024
ICER publishes final evidence report on treatment for chronic obstructive pulmonary disease
16 July 2024 - Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ...
Posted by Michael Wonder on 16 Jul 2024
Elranatamab for the treatment of patients with relapsed and refractory multiple myeloma after three or more treatments
12 July 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 16 Jul 2024
SMC - July 2024 decisions
8 July 2024 - Voretigene neparvovec (Luxturna) was accepted for the treatment of adults and children with an extremely rare inherited ...
Posted by Michael Wonder on 16 Jul 2024
AusperBio receives breakthrough therapy designation for AHB-137 in chronic hepatitis B treatment
10 July 2024 - AHB-137 gains breakthrough therapy designation from the NMPA based on Phase 1/Phase2a clinical trial data demonstrating safety ...
Posted by Michael Wonder on 16 Jul 2024
Arrivo announces FDA fast track designation for RABI-767 for patients with acute pancreatitis predicted to progress to severe disease
15 July 2024 - RABI-767 is a novel lipase inhibitor currently in a Phase 2a clinical trial. ...
Posted by Michael Wonder on 16 Jul 2024
Sumitomo Pharma announces that DSP-5336 has received FDA fast track designation for the treatment of relapsed or refractory acute myeloid leukaemia
15 July 2024 - -- Sumitomo Pharma today announced that the US FDA granted fast track designation to DSP-5336 for ...
Posted by Michael Wonder on 16 Jul 2024
Doug Ford wants Canada to approve drugs faster. Is that possible?
15 July 2024 - Talk of the delay in drugs is top of mind for Ford, who arrived in Nova Scotia ...