Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 17 Aug 2021
FDA grants accelerated approval of Jemperli (dostarlimab-gxly) for dMMR recurrent or advanced solid tumours
17 August 2021 - Second FDA approval of PD-1 antagonist antibody under clinical development for solid tumours in collaboration with GSK. ...
Posted by Michael Wonder on 17 Aug 2021
Helius Medical Technologies announces FDA breakthrough device designation for the treatment of dynamic gait and balance deficits following a stroke
17 August 2021 - Helius Medical Technologies today announced that it has received breakthrough designation from the U.S. FDA for its ...
Posted by Michael Wonder on 17 Aug 2021
Oncopeptides' Pepaxto receives a permanent J code, clarifying reimbursement processes in hospital outpatient and physician office settings of care
16 August 2021 - Oncopeptides today announced that the Centers for Medicare and Medicaid Services has established a specific billing Level ...
Posted by Michael Wonder on 17 Aug 2021
Information Act shows racism in PHARMAC’s decision-making
17 August 2021 - Paati Māori Co-leader, Debbie Ngarewa-Packer, has received information that blatantly outlines the inequity within PHARMAC and ...
Posted by Michael Wonder on 17 Aug 2021
Final terms of reference and public consultation to the post-market review of opiate dependence treatment program medicines
17 August 2021 - The public consultation process for the post-market review of opiate dependence treatment program medicines is now ...
Posted by Michael Wonder on 17 Aug 2021
PHARMAC to fund new cardiovascular medicine with amended Special Authority criteria
17 August 2021 - Pharmac has approved funding for a new medicine with substantial health benefits for around 75,000 New ...
Posted by Michael Wonder on 16 Aug 2021
Abbott's Amplatzer Amulet device approved by FDA to treat people with atrial fibrillation at risk of stroke
16 August 2021 - Amulet is the first and only minimally invasive treatment option to offer immediate closure of the left ...
Posted by Michael Wonder on 16 Aug 2021
Merck Canada initiates rolling submission to Health Canada for molnupiravir, an investigational oral therapeutic agent for the treatment of COVID-19
13 August 2021 - Merck today announced the initiation of a rolling submission to Health Canada for molnupiravir, an investigational twice ...
Posted by Michael Wonder on 16 Aug 2021
PHARMAC must explain funding decisions
16 August 2021 - “A report this morning that all PHARMAC staff, rather than clinical experts or those with patient ...
Posted by Michael Wonder on 16 Aug 2021
Spinal muscular atrophy: second and third active ingredients undergo benefit assessment
16 August 2021 - With risdiplam there is a hint of an added benefit for spinal muscular atrophy type 1, ...
Posted by Michael Wonder on 16 Aug 2021
Edgewise receives U.S. FDA fast track designation for EDG-5506 for the treatment of individuals with Becker muscular dystrophy
16 August 2021 - EDG-5506, a drug candidate designed to arrest muscle fibre breakdown in Becker and Duchenne muscular dystrophy, continues to ...
Posted by Michael Wonder on 16 Aug 2021
Carrick Therapeutics receives FDA fast track designations for two samuraciclib combinations for the treatment of HR+, HER2- advanced breast cancer and locally advanced or metastatic triple negative breast cancer
16 August 2021 - Carrick Therapeutics today announced that the U.S. FDA has granted Fast Track designations to samuraciclib in combination ...
Posted by Michael Wonder on 16 Aug 2021
Lanadelumab in hereditary angioedema: added benefit not proven
16 August 2021 - The active ingredient has exceeded the sales limit for the simplified orphan drug assessment. There are no ...
Posted by Michael Wonder on 16 Aug 2021
EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
16 August 2021 - EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment ...
Posted by Michael Wonder on 16 Aug 2021
Pfizer and BioNTech announce submission of initial data to U.S. FDA to support booster dose of COVID-19 vaccine
16 August 2021 - Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine ...