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 03 Aug 2021
Celltrion Healthcare announces acceptance and priority review by Health Canada of New Drug Submission for its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59)
2 August 2021 - Celltrion Healthcare Canada remains committed to working closely with Health Canada to make its monoclonal antibody treatment ...
Posted by Michael Wonder on 03 Aug 2021
Hansa Biopharma announces reimbursement in the Netherlands of Idefirix (imlifidase) as desensitisation treatment for highly sensitised kidney transplant patients
2 August 2021 - Idefiris (imlifidase) for enabling kidney transplantation in highly sensitised patients is now reimbursable and available for use ...
Posted by Michael Wonder on 03 Aug 2021
Mustang Bio receives European Medicines Agency PRIME designation for MB-107 to treat X-linked severe combined immunodeficiency in newly diagnosed infants
2 August 2021 - Mustang Bio today announced that the EMA has granted Priority Medicines designation to MB-107, its lentiviral ...
Posted by Michael Wonder on 03 Aug 2021
Amicus Therapeutics announces European Commission approval of Galafold (migalastat) for adolescents with Fabry disease
2 August 2021 - Galafold is the first and only oral therapy approved in the EU for the long-term treatment of ...
Posted by Michael Wonder on 03 Aug 2021
National Medicines Policy Review Committee and Terms of Reference
3 August 2021 - The National Medicines Policy has influenced a number of important strategies, frameworks and programs developed since ...
Posted by Michael Wonder on 02 Aug 2021
FDA’s Pazdur challenges attack on accelerated approval program
2 August 2021 - In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill ...
Posted by Michael Wonder on 02 Aug 2021
Novartis’ psoriatic arthritis drug to get expanded reimbursement
2 August 2021 - Novartis Korea said Monday its interleukin-17a inhibitor Cosentyx (secukinumab) began receiving reimbursement as a first-line biologics ...
Posted by Michael Wonder on 02 Aug 2021
Pfizer, Moderna raise prices of COVID-19 coronavirus vaccines for European Union
1 August 2021 - What’s the best way to get more people vaccinated against COVID-19 to try to end the ...
Posted by Michael Wonder on 02 Aug 2021
NICE approves first treatment in pilot of new approach to cost comparison fast track appraisals
2 August 2021 - As part of the recovery from the COVID-19 pandemic, NICE has been working hard to find new ...
Posted by Michael Wonder on 02 Aug 2021
UCB’s bimekizumab issued NICE recommendation for severe plaque psoriasis
2 August 2021 - NICE has issued a Final Appraisal Determination recommending UCB’s bimekizumab as an option for the treatment ...
Posted by Michael Wonder on 02 Aug 2021
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as adjuvant treatment for oesophageal or gastro-oesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
30 July 2021 - Approval is based on Phase 3 results from the CheckMate-577 trial. ...
Posted by Michael Wonder on 02 Aug 2021
Alkermes receives FDA fast track designation for nemvaleukin alfa for the treatment of mucosal melanoma
2 August 2021 - Alkermes today announced that the U.S. FDA has granted fast track designation to nemvaleukin alfa, the ...
Posted by Michael Wonder on 02 Aug 2021
Working towards harmonised access to clinical trial data across European drug regulatory agencies
31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...
Posted by Michael Wonder on 02 Aug 2021
GSK receives authorization under Health Canada's Interim Order for sotrovimab for Injection to treat COVID-19 in high-risk adults and adolescents
30 July 2021 - GSK announced today that Health Canada has granted an Interim Order Authorisation for sotrovimab for Injection (sotrovimab, ...
Posted by Michael Wonder on 02 Aug 2021
Benlysta now approved in Canada in addition to standard therapy for treatment of active lupus nephritis in adult patients
30 July 2021 - Benlysta (belimumab) has been approved in Canada for the treatment of active lupus nephritis in adult ...