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RSS FeedPosted by Michael Wonder on 06 May 2021
Alberta, Canada, begins mandating switches from originator to biosimilar Humira
6 May 2021 - Alberta, Canada becomes the latest province to begin switching patients from originator adalimumab (Humira) to biosimilar ...
Posted by Michael Wonder on 06 May 2021
The difference between an interchangeable biosimilar and one that isn't
5 May 2021 - Permitting automatic substitution of biosimilars for originator brand biologics at the pharmacy counter is often talked about ...
Posted by Michael Wonder on 06 May 2021
CMS increases Medicare payment for COVID-19 monoclonal antibody infusions
6 May 2021 - New payment policy for at-home administration. ...
Posted by Michael Wonder on 06 May 2021
Coverage of oncology medicines well aligned across Canadian provinces, but sources of funding differ
4 May 2021 - The Patented Medicine Prices Review Board, through the National Prescription Drug Utilisation Information System research initiative, today ...
Posted by Michael Wonder on 06 May 2021
Preliminary NICE 'no' for Merck's Bavencio
6 May 2021 - NICE has issued a preliminary rejection of NHS funds for use of Merck Serono's Bavencio (avelumab) ...
Posted by Michael Wonder on 06 May 2021
Injectafer (ferric carboxymaltose injection) receives FDA approval for single dose option for the treatment of adult patients with iron deficiency anaemia
6 May 2021 - For patients weighing 50 kg (110 lb) or more, Injectafer may now be administered as a 1000 ...
Posted by Michael Wonder on 06 May 2021
Merck and Eisai receive priority review from FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) applications for advanced renal cell carcinoma and for advanced endometrial carcinoma
6 May 2021 - Applications based on progression-free survival, overall survival, and objective response rate data from respective pivotal Phase 3 ...
Posted by Michael Wonder on 06 May 2021
European Commission approves Benlysta for adult patients with active lupus nephritis
5 May 2021 - First and only biologic approved for both systemic lupus erythematosus and lupus nephritis ...
Posted by Michael Wonder on 06 May 2021
Health Canada issues Notice of Compliance for Bausch Health's Bryhali
5 May 2021 - Bausch Health Canada today announced that Health Canada has approved the use of Bryhali (halobetasol propionate 0.01% ...
Posted by Michael Wonder on 05 May 2021
ICER releases draft evidence report on aducanumab for Alzheimer’s disease
5 May 2021 - Given the risk of side effects and the uncertainty of benefit, ICER assigns a draft rating of ...
Posted by Michael Wonder on 05 May 2021
'Intimidating' PHARMAC move may lead to child cancer drug delays
6 May 2021 - Two of New Zealand's leading cancer experts have slammed PHARMAC's proposal to take away the special exemption ...
Posted by Michael Wonder on 05 May 2021
FDA grants accelerated approval to pembrolizumab for HER2 positive gastric cancer
5 May 2021 - Today the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, ...
Posted by Michael Wonder on 05 May 2021
Canadian agency recommends Ruzurgi be reimbursed with conditions
5 May 2021 - CADTH has recommended that Ruzurgi (amifampridine) be reimbursed for the treatment of Lambert-Eaton myasthenic syndrome in ...
Posted by Michael Wonder on 05 May 2021
FDA accepts Amgen's supplemental new drug application for Otezla (apremilast) for adults with mild to moderate plaque psoriasis
5 May 2021 - Acceptance based on data from Phase 3 ADVANCE trial, demonstrating clinically meaningful improvements through week 32. ...
Posted by Michael Wonder on 05 May 2021
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib) in IDH1 mutated cholangiocarcinoma
5 May 2021 - Servier Pharmaceuticals today announced that the U.S. FDA has accepted the company's supplemental new drug application for ...