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RSS FeedPosted by Michael Wonder on 28 Oct 2020
Forxiga cardiovascular outcomes benefit approved in China
28 October 2020 - Update to approval includes DECLARE-TIMI 58 Phase 3 trial that reduced the risk of composite of hospitalisation ...
Posted by Michael Wonder on 27 Oct 2020
FDA approves lotion for non-prescription use to treat head lice
27 October 2020 - Today, the U.S. FDA approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use ...
Posted by Michael Wonder on 27 Oct 2020
NICE publishes appraisal consultation document for avapritinib
27 October 2020 - Avapritinib is used to treat patients with an unresectable or metastatic gastro-intestinal stromal tumour. ...
Posted by Michael Wonder on 27 Oct 2020
Sales of cancer medicines in Canada nearly tripled over the past decade
27 October 2020 - Today, the PMPRB, under the National Prescription Drug Utilization Information System (NPDUIS) initiative, released a chartbook ...
Posted by Michael Wonder on 27 Oct 2020
Mavenclad (cladribine tablets) is available through public drug plans for the majority of eligible Canadians with relapsing-remitting multiple sclerosis
27 October 2020 - EMD Serono is pleased to announce that eligible patients have access to Mavenclad (cladribine tablets) through ...
Posted by Michael Wonder on 27 Oct 2020
Dracen Pharmaceutical’s DRP-104 granted U.S. FDA fast track designation for the treatment of non-small cell lung cancer
27 October 2020 - Dracen to work closely with FDA to advance the clinical program for the treatment of non-small cell ...
Posted by Michael Wonder on 27 Oct 2020
Kala Pharmaceuticals announces FDA approval of Eysuvis for the short-term treatment of the signs and symptoms of dry eye disease
27 October 2020 - First approved prescription therapy specifically for short-term treatment of dry eye disease. ...
Posted by Michael Wonder on 27 Oct 2020
Prevail Therapeutics receives U.S. FDA fast track designation for PR001 for the treatment of neuronopathic Gaucher disease
27 October 2020 - Prevail Therapeutics today announced that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 27 Oct 2020
FDA grants priority review and EMA accepts regulatory submission for Pfizer's abrocitinib, an oral once daily JAK1 inhibitor, for patients 12 and up with moderate to severe atopic dermatitis
27 October 2020 - Filings based on robust abrocitinib clinical trial data demonstrating significant symptom improvement versus placebo as well as ...
Posted by Michael Wonder on 27 Oct 2020
PHARMAC responds to concerns about medication shortages
27 October 2020 - PHARMAC director of operations Lisa Williams talks to Kathryn about the COVID-19 disrupted manufacturing and supply chain ...
Posted by Michael Wonder on 27 Oct 2020
Incyte announces Health Canada acceptance of the new drug submission for pemigatinib as a treatment for patients with cholangiocarcinoma
26 October 2020 - Incyte today announced that Health Canada has accepted its new drug submission for pemigatinib, a selective fibroblast ...
Posted by Michael Wonder on 27 Oct 2020
Information specialist collaboration in Europe: collaborative methods, processes, and infrastructure through EUnetHTA
21 October 2020 - The history of European health technology assessment goes back more than 30 years. Almost as old as ...
Posted by Michael Wonder on 26 Oct 2020
Santen announces U.S. FDA filing acceptance of new drug application for cyclosporin 0.1% topical ophthalmic emulsion for the treatment of severe vernal keratoconjunctivitis in patients ages 4-18
26 October 2020 - Santen today announced that the U.S. FDA has accepted the new drug application for cyclosporin 0.1% topical ...
Posted by Michael Wonder on 26 Oct 2020
Forte Biosciences announces the FDA has granted fast track designation to FB-401 for the treatment of atopic dermatitis
26 October 2020 - Forte Biosciences today announced that the U.S. FDA has granted fast track designation to FB-401 for the ...
Posted by Michael Wonder on 26 Oct 2020
Janssen submits application to U.S. FDA for new indication to expand use of Xarelto (rivaroxaban) in patients with peripheral artery disease
26 October 2020 - Application seeks approval of Xarelto plus aspirin to reduce the risk of major thrombotic vascular events in ...