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RSS FeedPosted by Michael Wonder on 28 Oct 2020
Lilly announces agreement with U.S. government to supply 300,000 vials of investigational neutralising antibody bamlanivimab (LY-CoV555) in an effort to fight COVID-19
28 October 2020 - Initial agreement for 300,000 vials with potential for purchase of an additional 650,000 vials. ...
Posted by Michael Wonder on 28 Oct 2020
Enhertu granted priority review in the US for the treatment of HER2 positive metastatic gastric cancer
28 October 2020 - Only HER2 directed medicine to demonstrate significant improvement in overall survival compared to chemotherapy for previously ...
Posted by Michael Wonder on 28 Oct 2020
Taysha Gene Therapies receives rare paediatric disease designation and orphan drug designation for TSHA-104 to treat SURF1 associated Leigh syndrome
27 October 2020 - Taysha anticipated to submit Investigational new drug application for TSHA-104 to FDA in 2021. ...
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
COVID-19 vaccine rollout calls for supply chain collaboration, logistics chief says
26 October 2020 - Kuehne + Nagel CEO Detlef Trefzger says rush will be manageable despite strains on transportation capacity. ...
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
FDA approves new FoundationOne Liquid CDx companion diagnostic indications for three targeted therapies that treat advanced ovarian, breast and non-small cell lung cancer
27 October 2020 - Foundation Medicine today announced that the U.S. FDA approved FoundationOne Liquid CDx for three new companion ...
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
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 ...