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 23 Jul 2022
EMA CHMP recommends use of the Moderna COVID-19 booster in adolescents (12-17 Years) in the European Union
22 July 2022 - Moderna today announced that the EMA's CHMP has adopted a positive opinion recommending a variation to ...
Posted by Michael Wonder on 23 Jul 2022
European Union regulation of health technology assessment: what is required for it to succeed?
22 July 2022 - After considerable discussion and debate, the European Commission proposal for the regulation of health technology assessment was ...
Posted by Michael Wonder on 23 Jul 2022
Kite’s CAR T-cell therapy Tecartus receives positive CHMP opinion in relapsed or refractory acute lymphoblastic leukaemia
22 July 2022 - Tecartus (brexucabtagene autoleucel) first and only CAR T in Europe to receive positive CHMP opinion to ...
Posted by Michael Wonder on 23 Jul 2022
Vertex advances VX-548 in acute and neuropathic pain
22 July 2022 - Breakthrough therapy designation granted by FDA. ...
Posted by Michael Wonder on 23 Jul 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for LAG-3-blocking antibody combination Opdualag (nivolumab and relatlimab) for treatment of patients with unresectable or metastatic melanoma
22 July 2022 - Recommendation based on results from the Phase 2/3 RELATIVITY-047 trial, in which the fixed-dose combination of the ...
Posted by Michael Wonder on 23 Jul 2022
Alnylam receives positive CHMP opinion for vutrisiran for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy
22 July 2022 - Positive opinion based on HELIOS-A Phase 3 study. ...
Posted by Michael Wonder on 23 Jul 2022
New medicine for multiple myeloma patients with limited treatment options
22 July 2022 - The EMA has recommended a conditional marketing authorisation in the European Union for Tecvayli (teclistamab) for ...
Posted by Michael Wonder on 23 Jul 2022
EMA recommends approval of Imvanex for the prevention of monkeypox disease
22 July 2022 - The EMA’s has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults ...
Posted by Michael Wonder on 22 Jul 2022
EMA recommends restricting use of cancer medicine Rubraca
22 July 2022 - EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used ...
Posted by Michael Wonder on 22 Jul 2022
Daewoong Pharmaceutical gets first Korean US FDA fast track for new idiopathic pulmonary fibrosis drug
20 July 2022 - First-in-class new drug to quickly take on the pulmonary fibrosis market, predicted to reach $6.1 billion ...
Posted by Michael Wonder on 22 Jul 2022
Upstaza granted marketing authorisation by European Commission as first disease-modifying treatment for AADC deficiency
20 July 2022 - PTC Therapeutics to launch first gene therapy directly administered into the brain. ...
Posted by Michael Wonder on 22 Jul 2022
Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
20 July 2022 - EMA has endorsed a joint statement calling for international collaboration to enable the generation and use ...
Posted by Michael Wonder on 22 Jul 2022
Medicines industry working to minimise medicine supply shortages
22 July 2022 - Medicines Australia and the Generic and Biosimilars Medicines Association are deeply concerned about medicine shortages that ...
Posted by Michael Wonder on 21 Jul 2022
Barriers to accessing life-saving overdose reversal medicine are putting Kiwis at risk - NZ Drug Foundation
21 July 2022 - The lethal drug fentanyl has been found in New Zealand, prompting warnings that the country isn't ...
Posted by Michael Wonder on 21 Jul 2022
Pfizer announces Prevnar 20 (pneumococcal 20 valent conjugate vaccine) is now available in Canada for the prevention of pneumonia and invasive pneumococcal disease in adults 18 years of age and older
21 July 2022 - Prevnar 20 is the first conjugate vaccine indicated to help protect against 20 serotypes responsible for ...