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 11 Mar 2021
Medicare’s new device coverage pathway — breakthrough or breakdown?
10 March 2021 - CMS recently finalised a rule that could substantially alter Medicare coverage decisions for certain new medical devices. ...
Posted by Michael Wonder on 11 Mar 2021
FDA grants breakthrough device designation for Inivata’s RaDaR assay
9 March 2021 - Designation will help accelerate the regulatory path of RaDaR for use in detection of minimal residual ...
Posted by Michael Wonder on 11 Mar 2021
Kadmon announces U.S. FDA has extended the review period for belumosudil in chronic graft versus host disease
10 March 2021 - Kadmon today announced that the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 11 Mar 2021
Doubt over Australian COVID vaccine rollout completion date
11 March 2021 - The Health Department now “don’t know” if every Australian will be able to have both doses of ...
Posted by Michael Wonder on 10 Mar 2021
NICE publishes updated guidance on the use of pembrolizumab (Keytruda) for patients with untreated, metastatic, non-squamous non-small-cell lung cancer
10 March 2021 - Pembrolizumab was listed in the Cancer Drugs Fund for this indication. ...
Posted by Michael Wonder on 10 Mar 2021
NICE finally publishes final guidance for Aimovig
10 March 2021 - Erenumab has been recommended by NICE for certain patients with migraine. ...
Posted by Michael Wonder on 10 Mar 2021
AVEO Oncology announces U.S. FDA approval of Fotivda (tivozanib) for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma
10 March 2021 - AVEO plans to make Fotivda available to patients in the U.S. by 31 March 2021. ...
Posted by Michael Wonder on 10 Mar 2021
PBAC updates Public Summary Document for medicine without a published outcome
11 March 2021 - The Department of Health has updated the Public Summary Document for adalimumab (Humira) from the July ...
Posted by Michael Wonder on 10 Mar 2021
Vertex announces FDA fast track designation and initiation of a Phase 1/2 clinical trial for VX-880, a novel investigational cell therapy for the treatment of type 1 diabetes
10 March 2021 - VX-880 is the first investigational stem cell derived therapy utilising fully differentiated, insulin-producing pancreatic islet cells for ...
Posted by Michael Wonder on 10 Mar 2021
PHARMAC saving money at the expense of Kiwis' health
11 March 2021 - Peter Davis’ observations regarding PHARMAC funding new drugs every time there is a change of government ...
Posted by Michael Wonder on 10 Mar 2021
FDA accepts the new drug application for review of Idorsia’s daridorexant for the treatment of adult patients with insomnia
10 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant on ...
Posted by Michael Wonder on 10 Mar 2021
Australia’s Therapeutic Goods Administration approves Feraccru to treat iron deficiency with or without anaemia in adults
9 March 2021 - Shield Therapeutics notes that Australia’s Therapeutic Goods Administration has registered Feraccru in the Australian Register of ...
Posted by Michael Wonder on 10 Mar 2021
U.S. FDA accepts UVision360 submission for novel Luminelle DTx system biopsy sheath
9 March 2021 - UVision360 announces today that the U.S. FDA has accepted the Company's submission to expand the Luminelle DTx ...
Posted by Michael Wonder on 10 Mar 2021
TGA approves Zolgensma
10 March 2021 - Onasemnogene abeparvovec is a new gene therapy for children with spinal muscular atrophy. ...
Posted by Michael Wonder on 10 Mar 2021
Developers of Russian Sputnik V vaccine doubt EU regulator's neutrality, want apology
9 March 2021 - The developers of Russia’s Sputnik V vaccine against COVID-19 on Tuesday questioned the EMA's neutrality, after ...