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 03 Apr 2023
FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) ...
Posted by Michael Wonder on 02 Apr 2023
Pixium Vision announces FDA breakthrough device designation for the Prima System in dry AMD
31 March 2023 - PRIMAvera European pivotal trial in dry AMD fully recruited and on track to report primary endpoints around ...
Posted by Michael Wonder on 02 Apr 2023
Mitsubishi Tanabe Pharma Canada receives engagement letter from Pan-Canadian Pharmaceutical Alliance for Radicava oral suspension
31 March 2023 - Mitsubishi Tanabe Pharma Canada is pleased to announce the company has entered into negotiations with the ...
Posted by Michael Wonder on 02 Apr 2023
Samsung Bioepis receives positive CHMP opinion for eculizumab biosimilar, Epysqli
31 March 2023 - Epysqli, a biosimilar referencing Soliris (eculizumab), is Samsung Bioepis’ first biosimilar in haematology to be recommended for ...
Posted by Michael Wonder on 02 Apr 2023
Ensuring public trust in an empowered FDA
1 April 2023 - The FDA’s recent approval of lecanemab for Alzheimer’s disease has been clouded by controversy over other accelerated ...
Posted by Michael Wonder on 02 Apr 2023
Survey on patients' access to medicines for the treatment of rare health conditions
31 March 2023 - The TLV has submitted an interim report to the government for the task of proposing how ...
Posted by Michael Wonder on 02 Apr 2023
TG Therapeutics announces positive CHMP opinion for Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis in adults
31 March 2023 - TG Therapeutics today announced that the CHMP of the EMA has issued a positive opinion recommending ...
Posted by Michael Wonder on 02 Apr 2023
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy
31 March 2023 - Recommendation for approval based on Phase 3 TRANSFORM study, supporting the potential of Breyanzi in earlier ...
Posted by Michael Wonder on 02 Apr 2023
Novartis Entresto receives positive CHMP opinion for a heart failure
31 March 2023 - The positive opinion is based on final data from the 52 week Phase 3 PANORAMA-HF trial, the ...
Posted by Michael Wonder on 01 Apr 2023
Highlights from the 27 - 30 March 2023 CHMP meeting
31 March 2023 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting. ...
Posted by Michael Wonder on 01 Apr 2023
New Zealand Pharmaceutical Schedule - 1 April 2023
1 April 2023 The April 2023 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 01 Apr 2023
Schedule of Pharmaceutical Benefits - 1 April 2023
1 April 2023 - The April 2023 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 01 Apr 2023
Outcome statement - February 2023 DUSC meeting
31 March 2023 - The outcome statement from the February 2023 DUSC meeting is now available. ...
Posted by Michael Wonder on 30 Mar 2023
WHO advisers to consider whether obesity medication should be added to Essential Medicines List
30 March 2023 - Advisers to the World Health Organization will consider next month whether to add liraglutide, the active ingredient ...
Posted by Michael Wonder on 30 Mar 2023
EMA recommends approval of Bimervax as a COVID-19 booster vaccine
30 March 2023 - The EMA’s CHMP has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a ...