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 12 Jul 2022
FDA rule would facilitate prescription to OTC switches but nix a third class of drugs
12 July 2022 - After a decade long wait, the FDA finally issued a proposed rule in late June that ...
Posted by Michael Wonder on 12 Jul 2022
EMA launches pilot project on analysis of raw data from clinical trials
12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical ...
Posted by Michael Wonder on 12 Jul 2022
Hansa Biopharma announces first patient treated in the post-authorisation efficacy study of Idefirix (imlifidase) in highly sensitised kidney transplant patients
11 July 2022 - The study is an obligation under the conditional marketing authorisation for Idefirix granted by the EMA ...
Posted by Michael Wonder on 11 Jul 2022
Perrigo's HRA Pharma submits application to FDA for first ever OTC birth control pill
11 July 2022 - Perrigo today announced that HRA Pharma, a Perrigo company, has submitted its application to the U.S. ...
Posted by Michael Wonder on 11 Jul 2022
CADTH Advisory Panel report recommends framework for potential pan-Canadian formulary
11 July 2022 - In July 2021, the Government of Canada approached CADTH to develop a recommended framework for creating and ...
Posted by Michael Wonder on 11 Jul 2022
PHARMAC ‘procrastinating’ over funding glucose monitors, Diabetes NZ says
12 July 2022 - PHARMAC should stop procrastinating on funding glucose monitors for people with diabetes after the Government agency ...
Posted by Michael Wonder on 11 Jul 2022
T2 Biosystems receives FDA breakthrough device designation for the T2Lyme panel
11 July 2022 - Molecular diagnostic test for early detection of Lyme disease. ...
Posted by Michael Wonder on 11 Jul 2022
Arcutis Biotherapeutics announces Health Canada accepts for review the new drug submission for roflumilast cream for adults and adolescents with plaque psoriasis
11 July 2022 - Submission supported by positive clinical data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as ...
Posted by Michael Wonder on 11 Jul 2022
US FDA grants Spectral Medical breakthrough device designation for Toraymyxin for the treatment of endotoxemic septic shock
11 July 2022 - Breakthrough designation expected to help accelerate regulatory review. ...
Posted by Michael Wonder on 11 Jul 2022
SMC - July 2022 decisions
11 July 2022 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 11 Jul 2022
ICER launches initiative to evaluate and advance health technology assessment methods that support health equity
11 July 2022 - Funding from Commonwealth Fund supports a broad based initiative exploring potential changes in all health technology assessment ...
Posted by Michael Wonder on 11 Jul 2022
ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines
11 July 2022 - The European Centre for Disease Prevention and Control and the EMA are recommending that second booster ...
Posted by Michael Wonder on 11 Jul 2022
U.S. California will start making its own insulin to combat high drug prices, governor says
8 July 2022 - California Gov. Gavin Newsom announced Thursday that he approved a budget that allocates $100 million for ...
Posted by Michael Wonder on 11 Jul 2022
Governor Ron de Santis takes additional actions to lower prescription drug prices for Floridians
8 July 2022 - Today, Governor Ron DeSantis issued Executive Order 22-164 to drive transparency in prescription costs for Floridians. This ...
Posted by Michael Wonder on 11 Jul 2022
Anthos Therapeutics announces that abelacimab has received FDA fast track designation for the treatment of thrombosis associated with cancer
11 July 2022 - Abelacimab is a dual-acting fully human monoclonal antibody targeting both factor XI and Factor XIa with high ...