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 27 Jun 2022
Celltrion Healthcare receives CHMP positive opinion for biosimilar bevacizumab, Vegzelma (CT-P16)
27 June 2022 - The positive opinion is based on the totality of evidence including the Phase III study to evaluate ...
Posted by Michael Wonder on 26 Jun 2022
US seeks pharmaceutical deal with Switzerland to fast-track FDA approvals
27 June 2022 - The Biden administration wants to reach a narrow sectoral trade agreement with the Swiss pharmaceutical industry, ...
Posted by Michael Wonder on 26 Jun 2022
Price disclosure 2022 October cycle outcomes summary
24 June 2022 - The summary of price disclosure price reductions for the 2022 October Cycle has now been published on ...
Posted by Michael Wonder on 26 Jun 2022
PHARMAC widens flu vaccine access to increase uptake
27 June 2022 - PHARMAC today announced that it is permanently widening access to the annual funded flu vaccine to people ...
Posted by Michael Wonder on 26 Jun 2022
CHMP issues a positive opinion recommending full approval of Oncopeptides Pepaxti in EU for patients with triple class refractory multiple myeloma
23 June 2022 - Oncopeptides today announces that the EMA's CHMP, has unanimously adopted a positive opinion recommending a full marketing ...
Posted by Michael Wonder on 26 Jun 2022
Amryt to pursue formal dispute resolution for Oleogel-S10 (Filsuvez) NDA
24 June 2022 - Amryt today announces that the company plans to submit a formal dispute resolution request for the ...
Posted by Michael Wonder on 26 Jun 2022
Emergent BioSolutions announces FDA acceptance of biologics license application for AV7909 anthrax vaccine candidate
24 June 2022 - Emergent BioSolutions announced today that the U.S. FDA accepted for review the biologics license application for AV7909 ...
Posted by Michael Wonder on 26 Jun 2022
argenx receives positive CHMP opinion for efgartigimod for the treatment of adult patients with generalised myasthenia gravis in Europe
24 June 2022 - Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and ...
Posted by Michael Wonder on 26 Jun 2022
U.S. FDA approves Bristol Myers Squibb’s CAR T cell therapy Breyanzi for relapsed or refractory large B-cell lymphoma after one prior therapy
24 June 2022 - In the pivotal Phase 3 TRANSFORM trial, single infusion of Breyanzi significantly outperformed the nearly 30 year ...
Posted by Michael Wonder on 26 Jun 2022
First gene therapy to treat severe haemophilia A
24 June 2022 - EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) ...
Posted by Michael Wonder on 26 Jun 2022
Highlights from the 20-23 June 2022 CHMP meeting
24 June 2022 - EMA’s CHMP recommended nine medicines for approval at its June 2022 meeting. ...
Posted by Michael Wonder on 26 Jun 2022
Investigational lenacapavir receives positive CHMP opinion for people with multi-drug resistant HIV
24 June 2022 - Recommendation is based on week 26 data from the CAPELLA trial showing twice yearly lenacapavir achieved high ...
Posted by Michael Wonder on 25 Jun 2022
Novartis receives positive CHMP opinion for Scemblix, a novel treatment for adult patients with chronic myeloid leukaemia
24 June 2022 - ...
Posted by Michael Wonder on 24 Jun 2022
European Commission approves Filsuvez for the treatment of dystrophic and junctional epidermolysis bullosa
23 June 2022 - Filsuvez will be the first and only approved treatment for epidermolysis bullosa patients. ...
Posted by Michael Wonder on 24 Jun 2022
Health Canada expands approval of Enhertu for adults with HER2 positive metastatic breast cancer
23 June 2022 - Approval based on the ground-breaking DESTINY-Breast03 Phase 3 trial, showing Enhertu reduced the risk of disease ...