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 18 Jul 2021
U.S. FDA grants priority review for the biologics license application for Pfizer-BioNTech COVID-19 vaccine
16 July 2021 - Pfizer and BioNTech today announced that the U.S. FDA granted priority review designation for the biologics license ...
Posted by Michael Wonder on 18 Jul 2021
Considering and communicating uncertainty in health technology assessment
15 July 2021 - As health technology assessment seeks to combine complex sets of evidence, values, and perspectives to support open, ...
Posted by Michael Wonder on 17 Jul 2021
Aduhelm pros and cons debated at ICER meeting
16 July 2021 - Biogen officials defended the company's Alzheimer's drug and criticised ICER's cost effectiveness report today at a meeting ...
Posted by Michael Wonder on 17 Jul 2021
Merck announces U.S. FDA approval of Vaxneuvance (Pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes
16 July 2021 - Clinical data supporting approval demonstrated non-inferior immune responses for the serotypes shared with PCV13 (1, 3, 4, ...
Posted by Michael Wonder on 16 Jul 2021
FDA approves new use of transplant drug based on real world evidence
16 July 2021 - Today, the U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a ...
Posted by Michael Wonder on 16 Jul 2021
FDA approves belumosudil for chronic graft versus host disease
16 July 2021 - On 16 July 2021, the FDA approved belumosudil (Rezurock, Kadmon Pharmaceuticals), a kinase inhibitor, for adult ...
Posted by Michael Wonder on 16 Jul 2021
Ledaga recommended by NICE for rare type of lymphoma
16 July 2021 - NICE has recommended Recordati Rare Diseases and Helsinn Healthcare’s Ledaga for a type of lymphoma that ...
Posted by Michael Wonder on 16 Jul 2021
NICE’s decision not to approve Zytiga ‘frustrating’, says ICR
16 July 2021 - NICE has decided not to recommend Janssen’s Zytiga after reviewing its previous decision to reject the ...
Posted by Michael Wonder on 16 Jul 2021
International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines
16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...
Posted by Michael Wonder on 16 Jul 2021
PBAC Public Summary Documents (first time rejections and deferrals) – March 2021 meeting
16 July 2021 - The Public Summary Documents (first time rejections and deferrals) from the March 2021 PBAC meeting are now ...
Posted by Michael Wonder on 16 Jul 2021
Ocugen announces initiation of rolling submission to Health Canada for Covaxin
15 July 2021 - Ocugen today announced that it had initiated a rolling submission to Health Canada for Covaxin, the ...
Posted by Michael Wonder on 16 Jul 2021
EMA validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A
15 July 2021 - Potential first gene therapy in Europe for treatment of haemophilia A. ...
Posted by Michael Wonder on 16 Jul 2021
HutchMed’s marketing authorisation application for surufatinib submitted and validated by the European Medicines Agency
15 July 2021 - EMA commences review of surufatinib for the treatment of advanced neuroendocrine tumours. ...
Posted by Michael Wonder on 15 Jul 2021
‘Pharmacies are ready to go’: Chemists in hotspots fast tracked to deliver jabs
16 July 2021 - About 70 pharmacies in Sydney’s COVID-19 hotspots have been fast-tracked to administer AstraZeneca jabs from next ...
Posted by Michael Wonder on 15 Jul 2021
G-BA sees “considerable additional benefit” in two active ingredients - EU HTA analysis is coming
15 July 2021 - The Federal Joint Committee (G-BA) today certified two active ingredients with a "considerable additional benefit". It assigns ...