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 07 May 2021
Rather than turning its back on the QALY, pharma should collaborate on efforts to improve it
7 May 2021 - A key element in the long-simmering debate on reining in drug prices in the United States ...
Posted by Michael Wonder on 07 May 2021
The National Audit Office's review can contribute to strengthening TLV's work
7 May 2021 - On 6 May, the National Audit Office published its report on the Government's and TLV's work ...
Posted by Michael Wonder on 07 May 2021
International regulators and WHO call for wider public access to clinical data
7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...
Posted by Michael Wonder on 07 May 2021
Avelumab not recommended as a maintenance treatment of urothelial cancer after platinum-based chemotherapy
7 May 2021 - NICE has issued draft guidance which does not recommend avelumab for maintenance treatment of locally advanced or ...
Posted by Michael Wonder on 07 May 2021
EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19
7 May 2021 - EMA’s CHMP has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and ...
Posted by Michael Wonder on 07 May 2021
Updated agenda for the July 2021 PBAC meeting
7 May 2021 - The agenda for the July 2021 PBAC meeting has been updated. ...
Posted by Michael Wonder on 06 May 2021
ICER to assess treatment for severe asthma
6 May 2021 - Report will be subject of Midwest CEPAC meeting in November 2021; draft scoping document open to ...
Posted by Michael Wonder on 06 May 2021
Alberta, Canada, begins mandating switches from originator to biosimilar Humira
6 May 2021 - Alberta, Canada becomes the latest province to begin switching patients from originator adalimumab (Humira) to biosimilar ...
Posted by Michael Wonder on 06 May 2021
The difference between an interchangeable biosimilar and one that isn't
5 May 2021 - Permitting automatic substitution of biosimilars for originator brand biologics at the pharmacy counter is often talked about ...
Posted by Michael Wonder on 06 May 2021
CMS increases Medicare payment for COVID-19 monoclonal antibody infusions
6 May 2021 - New payment policy for at-home administration. ...
Posted by Michael Wonder on 06 May 2021
Coverage of oncology medicines well aligned across Canadian provinces, but sources of funding differ
4 May 2021 - The Patented Medicine Prices Review Board, through the National Prescription Drug Utilisation Information System research initiative, today ...
Posted by Michael Wonder on 06 May 2021
Viome receives FDA approval for its unique mRNA technology and AI platform to detect cancers
6 May 2021 - FDA breakthrough designation validates Viome's proprietary mRNA analysing technology and state of the art AI platform to ...
Posted by Michael Wonder on 06 May 2021
Preliminary NICE 'no' for Merck's Bavencio
6 May 2021 - NICE has issued a preliminary rejection of NHS funds for use of Merck Serono's Bavencio (avelumab) ...
Posted by Michael Wonder on 06 May 2021
Injectafer (ferric carboxymaltose injection) receives FDA approval for single dose option for the treatment of adult patients with iron deficiency anaemia
6 May 2021 - For patients weighing 50 kg (110 lb) or more, Injectafer may now be administered as a 1000 ...
Posted by Michael Wonder on 06 May 2021
Merck and Eisai receive priority review from FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) applications for advanced renal cell carcinoma and for advanced endometrial carcinoma
6 May 2021 - Applications based on progression-free survival, overall survival, and objective response rate data from respective pivotal Phase 3 ...