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 17 Apr 2023
AbbVie announces European Commission approval of Rinvoq (upadacitinib) for the treatment of moderately to severely active Crohn's disease
17 April 2023 - Seventh approved indication for Rinvoq in the European Union and the first and only oral janus kinase ...
Posted by Michael Wonder on 16 Apr 2023
Price of a life: Australians wait two years longer for breakthrough medicines than US citizens
16 April 2023 - Australians are waiting two years longer to access new lifesaving subsidised medicines because of pharma giants. Now, ...
Posted by Michael Wonder on 16 Apr 2023
Horizon Therapeutics announces FDA approval of an update to the indication language for Tepezza (teprotumumab-trbw) to specify its use in thyroid eye disease patients regardless of disease activity or duration
14 April 2023 - Updated indication language reinforces the importance of unrestricted access for patients across full spectrum of thyroid ...
Posted by Michael Wonder on 16 Apr 2023
Australian cancer patients spend $200 million a year on treatments not on the PBS and it’s got to change
16 April 2023 - Australian cancer patients were spending in excess of $200m each year of their own money on therapies ...
Posted by Michael Wonder on 15 Apr 2023
Pfizer Canada initiates submission to Health Canada for its bivalent respiratory syncytial virus vaccine
14 April 2023 - Indications under review include prevention of respiratory syncytial virus in infants from birth through 6 months ...
Posted by Michael Wonder on 14 Apr 2023
Throwing the baby out with the bath water: Congress considers banning the QALY
3 April 2023 - In late March, the House Committee on Energy and Commerce advanced H.R. 485 - Protecting Health ...
Posted by Michael Wonder on 14 Apr 2023
Alvotech provides regulatory update on AVT02 biologics license application
13 April 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics license ...
Posted by Michael Wonder on 14 Apr 2023
Genetesis receives second FDA breakthrough device designation for non-invasive diagnosis of myocardial ischaemia using CardioFlux MCG
13 April 2023 - Designation represents progress for patients with suspected coronary microvascular dysfunction as the FDA recognises disease’s debilitating impacts ...
Posted by Michael Wonder on 13 Apr 2023
SAB Biotherapeutics granted fast track designation from FDA for SAB-176 influenza immunotherapy with high cross-reactivity to multiple strains of influenza
13 April 2023 - FDA greenlights advancement of SAB-176 Phase 2b trial and manufacturing approach to address influenza strain change. ...
Posted by Michael Wonder on 13 Apr 2023
‘A global outlier’: how drug firms are fighting back against UK tax increases
13 April 2023 - With the UK tax on net sales of branded medicines quadrupling over the past three years, medicine ...
Posted by Michael Wonder on 13 Apr 2023
How ‘surrogate outcomes’ influence long-term health outcomes
13 April 2023 - NICE working with international organisations to develop guidance. ...
Posted by Michael Wonder on 13 Apr 2023
Regulatory, health technology assessment and company interactions: the current landscape and future ecosystem for drug development, review and reimbursement
11 April 2023 - The aims of this study were to review the current interactions within and across regulatory and HTA ...
Posted by Michael Wonder on 13 Apr 2023
U.S. FDA issues complete response letter for mirikizumab
13 April 2023 - Eli Lilly announced the US FDA has issued a complete response letter for the mirikizumab biologic license ...
Posted by Michael Wonder on 13 Apr 2023
ICER publishes evidence report on treatments for non-alcoholic steatohepatitis
13 April 2023 - Current evidence suggests that resmetirom would achieve common thresholds for cost effectiveness if priced between $39,600–$50,100 per ...
Posted by Michael Wonder on 13 Apr 2023
FDA accepts application for Merck’s Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for locally advanced unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma
13 April 2023 - Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit ...