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RSS FeedPosted by Michael Wonder on 10 Nov 2020
ICER provides second update to pricing models for remdesivir as a treatment for COVID-19
10 November 2020 - Based on an analysis of four studies evaluating remdesivir’s influence on mortality, ICER has concluded that the ...
Posted by Michael Wonder on 10 Nov 2020
New cancer drugs to be covered by National Health Insurance
11 November 2020 - Several new drugs for the treatment of three types of cancer have been approved for inclusion ...
Posted by Michael Wonder on 10 Nov 2020
Manufacturer moves to bring 'life-changing' cystic fibrosis drugs to Canada
10 November 2020 - A pharmaceutical company says it's taking steps to bring cystic fibrosis drugs to Canada in a ...
Posted by Michael Wonder on 10 Nov 2020
Health Canada approves Maviret 8 week treatment duration for treatment naïve patients with genotype 3 compensated cirrhosis
10 November 2020 - Maviret (glecaprevir/pibrentasvir) is the only 8 week oral treatment approved for all hepatitis C virus genotypes. ...
Posted by Michael Wonder on 10 Nov 2020
Bausch Health Canada receives a positive recommendation from the CADTH Canadian Drug Expert Committee for Duobrii - a novel topical anti-psoriatic prescription drug
10 November 2020 - Positive CADTH recommendation moves Duobrii closer to federal, provincial and territorial drug plan reimbursement. ...
Posted by Michael Wonder on 10 Nov 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of pancreatic cancer
10 November 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 10 Nov 2020
Supernus provides regulatory updates for SPN-812 and SPN-830
9 November 2020 - The U.S. FDA has issued a complete response letter regarding the new drug application for SPN-812 ...
Posted by Michael Wonder on 10 Nov 2020
Patients in other countries are getting access to breakthrough cancer drugs faster than Aussies
11 November 2020 - Old news and hardly an exclusive. ...
Posted by Michael Wonder on 10 Nov 2020
EUSA Pharma and BeiGene announce acceptance of a biologics license application for Qarziba (dinutuximab beta) in Chin
9 November 2020 - EUSA Pharma and BeiGene today announced that the biologics license application for Qarziba (dinutuximab beta) was accepted ...
Posted by Michael Wonder on 10 Nov 2020
Bayer submits marketing authorization applications for finerenone in the U.S. and the EU for patients with chronic kidney disease and type 2 diabetes
9 November 2020 - Regulatory submissions based on positive data from Phase 3 FIDELIO-DKD trial recently published in the New England ...
Posted by Michael Wonder on 10 Nov 2020
Mirum Pharmaceuticals broadens Expanded Access Program for maralixibat in Alagille syndrome to Europe and Australia
5 November 2020 - Maralixibat Expanded Access Program now available for patients with pruritus associated with Alagille syndrome in Australia and ...
Posted by Michael Wonder on 10 Nov 2020
Lilly's neutralising antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorisation for the treatment of recently diagnosed COVID-19
9 November 2020 - Bamlanivimab is authorised for treatment of recently diagnosed, mild to moderate COVID-19 in high-risk patients. ...
Posted by Michael Wonder on 10 Nov 2020
Orphazyme submits European Marketing Authorisation application for arimoclomol for treatment of Niemann-Pick disease Type C
9 November 2020 - Follows U.S. FDA acceptance of new drug application with priority review in September 2020. ...
Posted by Michael Wonder on 09 Nov 2020
Eligible patients living with rare debilitating genetic disorder are one step closer to having access to first-of-its-kind treatment option
5 November 2020 - Takeda Canada is pleased to announce it has completed the Letter of Intent with the pan Canadian ...
Posted by Michael Wonder on 09 Nov 2020
New osteoporosis drug for women approved for use on NHS in Scotland
9 October 2020 - A new drug to treat women with severe cases of the bone disease osteoporosis has been ...