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RSS FeedPosted by Michael Wonder on 25 Jan 2021
FDA grants toripalimab fast track designation for mucosal melanoma
25 January 2021 - Junshi Biosciences announced today that U.S. FDA has granted toripalimab fast track designation for the first-line treatment ...
Posted by Michael Wonder on 24 Jan 2021
The stakes for choosing the right FDA commissioner couldn’t be higher
24 January 2021 - An independent, credible, science led Food and Drug Administration has long been vital to America’s public, ...
Posted by Michael Wonder on 24 Jan 2021
Canada’s drug makers rattle their sabers over a government plan to control medicine spending
21 January 2021 - A majority of pharmaceutical executives in Canada say new regulations designed to cut prescription drug spending ...
Posted by Michael Wonder on 24 Jan 2021
BioCryst announces approval of Orladeyo (berotralstat) in Japan for the prophylactic treatment of hereditary angioedema
22 January 2021 - BioCryst Pharmaceuticals today announced that the Ministry of Health, Labor and Welfare in Japan has granted ...
Posted by Michael Wonder on 23 Jan 2021
FDA approves Aurinia Pharmaceuticals’ Lupkynis (voclosporin) for adult patients with active lupus nephritis
22 January 2021 - Lupkynis is the first FDA approved oral therapy for lupus nephritis, a condition that causes irreversible kidney ...
Posted by Michael Wonder on 22 Jan 2021
ICER publishes evidence report on therapies for high cholesterol
22 January 2021 - The evidence suggests that inclisiran can substantially lower LDL-C with limited safety concerns, and with a ...
Posted by Michael Wonder on 22 Jan 2021
FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma
22 January 2021 - Today the FDA approved the combination of nivolumab (Opdivo, Bristol-Myers) and cabozantinib (Cabometyx, Exelixis) as ...
Posted by Michael Wonder on 22 Jan 2021
ICER releases draft evidence report on therapies for lupus nephritis
22 January 2021 - Public comment period now open until 18 February 2021; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 22 Jan 2021
Menarini receives European Commission approval of Elzonris (tagraxofusp), for the treatment of blastic plasmacytoid dendritic cell neoplasm
21 January 2021 - Elzonris is the first approved treatment for patients with blastic plasmacytoid dendritic cell neoplasm, and the ...
Posted by Michael Wonder on 22 Jan 2021
Incyte announces acceptance and priority review of BLA for retifanlimab as a potential treatment for patients with squamous cell carcinoma of the anal canal
21 January 2021 - Incyte today announced that the U.S. FDA has accepted for priority review its biologics license application for ...
Posted by Michael Wonder on 22 Jan 2021
NICE recommends Jyseleca (filgotinib) on NHS in landmark decision for rheumatoid arthritis
21 January 2021 - NICE guidance, for the first time in the UK, supports access to an advanced therapy for people ...
Posted by Michael Wonder on 21 Jan 2021
FDA approves first extended release, injectable drug regimen for adults living with HIV
21 January 2021 - The U.S. FDA today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the ...
Posted by Michael Wonder on 21 Jan 2021
Biden appoints veteran Woodcock as interim FDA commissioner
21 January 2021 - Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden ...
Posted by Michael Wonder on 21 Jan 2021
Industry pooling helps maintain affordability of high cost drugs despite significant inflationary pressures
21 January 2021 - In 2019, the Canadian Drug Insurance Pooling Corporation's (CDIPC) high-cost drug sharing framework provided coverage to ...
Posted by Michael Wonder on 21 Jan 2021
FDA grants priority review to Genentech’s Esbriet (pirfenidone) for unclassifiable interstitial lung disease
21 January 2021 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental new drug application and granted ...