Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 21 Mar 2025
Public Summary Documents (first time rejections and deferrals)– November 2024 PBAC meeting
21 March 2025 - The Public Summary Documents (first time decisions not to recommend and deferrals) from the November 2024 PBAC ...
Posted by Michael Wonder on 21 Mar 2025
Strengthening Medicare: cheaper medicines to get even cheaper
20 March 2025 - The Albanese Labor Government is making cheaper medicines even cheaper – with a script to cost ...
Posted by Michael Wonder on 21 Mar 2025
Novartis receives third FDA approval for oral Fabhalta (iptacopan) – the first and only treatment approved in C3 glomerulopathy
20 March 2025 - Phase 3 study showed sustained proteinuria reduction at one year with favourable safety. ...
Posted by Michael Wonder on 21 Mar 2025
Hikma announces Health Canada approval of Kloxxado (naloxone hydrochloride) nasal spray 8 mg
20 March 2025 - Emergent BioSolutions will lead commercial launch efforts to increase access to intranasal naloxone and combat opioid overdose ...
Posted by Michael Wonder on 21 Mar 2025
Alnylam announces FDA approval of Amvuttra (vutrisiran), the first RNAi therapeutic to reduce cardiovascular death, hospitalisations and urgent heart failure visits in adults with ATTR amyloidosis with cardiomyopathy
20 March 2025 - Only therapeutic approved in the US to address both cardiomyopathy and polyneuropathy manifestations of ATTR amyloidosis. ...
Posted by Michael Wonder on 21 Mar 2025
US FDA approves Tremfya (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease
20 March 2025 - Supported by data from the GALAXI study, Tremfya is the only IL-23 inhibitor to show superiority versus ...
Posted by Michael Wonder on 21 Mar 2025
Why US drug giants are so angry about Australia’s PBS
20 March 2025 - US pharmaceutical giants hope the protectionist Trump administration will force Australia to increase the price it pays ...
Posted by Michael Wonder on 21 Mar 2025
Secretome Therapeutics granted FDA fast track designation for STM-01, a neonatal cardiac progenitor cell therapy for HFpEF
20 March 2025 - Secretome Therapeutics today announced that the US FDA has granted fast track designation to STM-01, the company’s ...
Posted by Michael Wonder on 20 Mar 2025
Health Economics Methods Advisory Group selects first area for study: assessing treatment benefits appropriate to consider in HTA decision-making
18 March 2025 - The US based ICER, England’s NICE and Canada’s Drug Agency have selected the first research topic ...
Posted by Michael Wonder on 20 Mar 2025
FDA approves pembrolizumab for HER2 positive gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1
19 March 2025 - Today, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy ...
Posted by Michael Wonder on 20 Mar 2025
Azercabtagene zapreleucel granted FDA fast track designation in blood cancer DLBCL
19 March 2025 - Imugene is pleased to announce that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 20 Mar 2025
Health Canada approves Keytruda for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma, in combination with carboplatin and paclitaxel and then continued as monotherapy
19 March 2025 - Approval is based on the Phase 3 KEYNOTE-868/NRG-GY018 trial. ...
Posted by Michael Wonder on 20 Mar 2025
PBS medication to cost no more than $25 under Labor re-election pitch
19 March 2025 - Australians are set to save a combined $200 million a year under the plan, which will cost ...
Posted by Michael Wonder on 20 Mar 2025
Australia defends PBS as US companies urge Trump to impose reciprocal tariffs
19 March 2025 - American medical giants have labelled the federal government's PBS "egregious and discriminatory" and have pressed US ...
Posted by Michael Wonder on 20 Mar 2025
Big pharma’s plea to Trump to punish Australia for cheaper medicines
19 March 2025 - American medical giants have slammed the $18 billion pharmaceutical benefits scheme in a plea to US ...