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 2024
Incorporating real option value in valuing innovation: a way forward
10 July 2024 - Considerable progress has been made in defining and measuring the real option value of medical technologies. ...
Posted by Michael Wonder on 12 Jul 2024
AskBio receives FDA fast track and MHRA Innovation Passport designations for AB-1005 investigational GDNF gene therapy for Parkinson’s disease
11 July 2024 - Bayer AG and Asklepios BioPharmaceutical today announced that the US FDA has granted fast track designation ...
Posted by Michael Wonder on 11 Jul 2024
FTC to sue drug managers over insulin prices
10 July 2024 - Antitrust agency is investigating how PBMs and manufacturers negotiate discounts. ...
Posted by Michael Wonder on 11 Jul 2024
Australian children with neuroblastoma given free access to 500,000 dollar cancer drug DFMO
10 July 2024 - Australian children and young adults with neuroblastoma, a cancer that affects the nervous system, will be ...
Posted by Michael Wonder on 11 Jul 2024
Novo Nordisk receives complete response letter in the US for once weekly basal insulin icodec
10 July 2024 - Novo Nordisk today announced that the US FDA has issued a complete response letter covering the ...
Posted by Michael Wonder on 10 Jul 2024
Pharma company lawsuit forces Dutch health agency to reassess cancer drug
9 July 2024 - The Dutch healthcare procurement agency has said it will reassess the breast cancer drug abemaciclib after ...
Posted by Michael Wonder on 10 Jul 2024
Aplidin will be re-evaluated by the EMA. The European Commission revokes the decision that initially denied PharmaMar's marketing authorisation for multiple myeloma due to a conflict of interest.
8 July 2024 - The European Commission has acknowledged that an expert from the Scientific Advisory Group, who was developing a ...
Posted by Michael Wonder on 10 Jul 2024
Outlook Therapeutics announces UK MHRA marketing authorisation of Lytenava (bevacizumab gamma) for the treatment of wet AMD
8 July 2024 - Initial commercial launches of Lytenava (bevacizumab gamma) in the EU and UK anticipated in calendar Q1, 2025. ...
Posted by Michael Wonder on 10 Jul 2024
NICE recommends Ebglyss (lebrikizumab) for use in moderate to severe atopic dermatitis in the NHS England in eligible adolescents and adults
10 July 2024 - Following approval of the European Commission (October 2023) and the MHRA (December 2023), lebrikizumab will be available ...
Posted by Michael Wonder on 10 Jul 2024
Updates to the HTA Policy and Methods Review
10 July 2024 - The Health Technology Assessment (HTA) Policy and Methods Review concluded on 4 May 2024. The HTA ...
Posted by Michael Wonder on 10 Jul 2024
Mirum Pharmaceuticals’ Livmarli approved in the European Union for patients with progressive familial intrahepatic cholestasis
8 July 2024 - Mirum Pharmaceuticals today announced that the European Commission has granted marketing authorization for Livmarli (maralixibat) oral solution ...
Posted by Michael Wonder on 10 Jul 2024
Lisocabtagene maraleucel for the treatment of adults with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma
10 July 2024 - NICE is unable to make a recommendation about the use in the NHS of lisocabtagene maraleucel (Breyanzi) ...
Posted by Michael Wonder on 10 Jul 2024
Over 6,000 people will benefit from PHARMAC funding proposal if approved
10 July 2024 - PHARMAC plans to widen access to seven medicines benefitting over 6,000 people within the first 12 ...
Posted by Michael Wonder on 10 Jul 2024
Obsidian Therapeutics announces FDA fast track designation for OBX-115 for the treatment of advanced melanoma
9 July 2024 - Obsidian Therapeutics today announced that the US FDA has granted fast track designation to OBX-115, a ...
Posted by Michael Wonder on 09 Jul 2024
FDA approves Arcutis’ Zorvye (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age
9 July 2024 - Commercial product expected to be available by the end of July. ...