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RSS FeedPosted 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 ...
Posted by Michael Wonder on 21 Jan 2021
NICE publishes final guidance backing Jyseleca for rheumatoid arthritis
21 January 2021 - NICE has published its final appraisal determination recommending the use of Gilead Sciences and Galapagos’ Jyseleca ...
Posted by Michael Wonder on 21 Jan 2021
Human medicines: highlights of 2020
21 January 2021 - EMA has published an PDF iconoverview of its key recommendations in 2020 on the authorisation and ...
Posted by Michael Wonder on 21 Jan 2021
Sanofi’s RSV treatment nirsevimab awarded PIM status
20 January 2021 - Sanofi’s nirsevimab has been awarded a Promising Innovative Medicine designation by the Medicines and Healthcare Products ...
Posted by Michael Wonder on 21 Jan 2021
Impel NeuroPharma announces U.S. FDA acceptance of new drug application for INP104 for the acute treatment of migraine
20 January 2021 - FDA conditionally accepts trade name, Trudhesa, pending approval of the new drug application, and sets PDUFA goal ...
Posted by Michael Wonder on 21 Jan 2021
Doptelet (avatrombopag) approved in the EU for treatment of ITP
20 January 2021 - Sobi today announced that the European Commission has approved an extension of the indication for Doptelet ...
Posted by Michael Wonder on 21 Jan 2021
With a new president and a new Congress, it's time for Medicare drug price negotiation
20 January 2021 - Since passage of the Medicare Modernization Act in 2003, which prohibited Medicare from negotiating prescription drug prices, ...
Posted by Michael Wonder on 20 Jan 2021
U.S. FDA accepts for priority review application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
20 January 2021 - U.S. FDA assigned a target action date of 25 May 2021. ...