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 26 Jul 2022
European Commission approves Rinvoq (upadacitinib) for the treatment of adults with moderate to severe ulcerative colitis
26 July 2022 - The approval is based on the results of three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 26 Jul 2022
TGA gives a tick to Scemblix
26 July 2022 - Asciminib is an oral and potent inhibitor of Abelson non-receptor tyrosine kinases/breakpoint cluster region (ABL/BCR): ABL1 tyrosine ...
Posted by Michael Wonder on 26 Jul 2022
Pfizer loses U.S. appeal over co-pays for heart failure patients
26 July 2022 - A federal appeals court on Monday rejected Pfizer's challenge to a U.S. anti-kickback law the drugmaker ...
Posted by Michael Wonder on 25 Jul 2022
Anti-PD-1 monoclonal antibody Puyouheng (HX-008, pucotenlimab) co-developed by Lepu Biopharma and HanX Biopharmaceuticals was approved for marketing in China by NMPA
25 July 2022 - Anti-PD-1 monoclonal antibody – Puyouheng (HX-008, pucotenlimab), was conditionally approved by the NMPA for marketing in China ...
Posted by Michael Wonder on 25 Jul 2022
BridgeBio Pharma and Sentynl Therapeutics receive positive CHMP opinion for Nulibry (fosdenopterin) for the treatment of MoCD type A
25 July 2022 - CHMP recommendation for approval of Nulibry in the European Union for the treatment of patients with molybdenum ...
Posted by Michael Wonder on 25 Jul 2022
HLS announces that Vascepa is now reimbursed by Ontario's Provincial Drug Plan
25 July 2022 - Reimbursement for Vascepa in Canada is now at more than 65% for publicly covered lives and private ...
Posted by Michael Wonder on 25 Jul 2022
Treosulphan NDA resubmitted to FDA
25 July 2022 - Pivotal Phase 3 clinical trial of treosulphan met primary endpoint and key secondary endpoints. ...
Posted by Michael Wonder on 25 Jul 2022
TGA provisionally approves the Biocelect (Novavax) COVID-19 vaccine, Nuvaxovid, for use in individuals aged 12-17 years
25 July 2022 - The TGA has provisionally approved the Biocelect (on behalf of Novavax) COVID-19 vaccine, Nuvaxovid, for use in ...
Posted by Michael Wonder on 25 Jul 2022
Policy updates on access to and affordability of innovative medicines in China
22 July 2022 - In China, efforts to qualify innovative medical products for reimbursement used to be subject to substantial delays ...
Posted by Michael Wonder on 25 Jul 2022
U.S. drug prices sky high in international comparison
22 July 2022 - U.S. residents are paying more than twice as much for prescription drugs as people living in other ...
Posted by Michael Wonder on 25 Jul 2022
Tezspire recommended for approval in the EU by CHMP for the treatment of severe asthma
25 July 2022 - First and only biologic recommended for EU approval in patients with severe asthma with no phenotype ...
Posted by Michael Wonder on 25 Jul 2022
Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with generalised myasthenia gravis
25 July 2022 - First and only long-acting C5 complement inhibitor showed early effect and demonstrated clinical improvement in activities ...
Posted by Michael Wonder on 25 Jul 2022
Enhertu granted priority review in the U.S. for patients with HER2 low metastatic breast cancer
25 July 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis. ...
Posted by Michael Wonder on 25 Jul 2022
Applications for proposed first of a kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
Posted by Michael Wonder on 25 Jul 2022
FDA describes plans to expand remote regulatory assessments
22 July 2022 - The US FDA released draft guidance on Friday that formalises its plans for using remote regulatory assessments ...