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RSS FeedPosted by Michael Wonder on 27 Aug 2020
KYE Pharmaceuticals and Catalyst Pharmaceuticals challenge Health Canada’s decision to overlook Firdapse data exclusivity
26 August 2020 - Catalyst Pharmaceuticals and KYE Pharmaceuticals today announced the filing of a proceeding in Canadian Federal Court ...
Posted by Michael Wonder on 27 Aug 2020
European Commission approves Blenrep (belantamab mafodotin) for the treatment of patients with relapsed and refractory multiple myeloma
26 August 2020 - Marketing authorisation follows the recent US approval of Blenrep. ...
Posted by Michael Wonder on 27 Aug 2020
Mylan, Lupin launch etanercept biosimilar in Germany
26 August 2020 - The launch marks the first European market entry for Nepexto. ...
Posted by Michael Wonder on 27 Aug 2020
The EU Commission grants conditional approval for Idefirix (imlifidase) in highly sensitised kidney transplant patients in the European Union
26 August 2020 - The conditional approval by the European Commission serves as a landmark milestone for Hansa Biopharma, as Idefirix ...
Posted by Michael Wonder on 26 Aug 2020
Catalyst takes its fight over a rare disease drug to Canada, suing the country’s regulator
26 August 2020 - In unusual battle between two small companies over the market for a rare disease drug has ...
Posted by Michael Wonder on 26 Aug 2020
Drug pricing executive order: will consumers get the reforms they need?
26 August 2020 - The August 24 deadline President Trump imposed on pharmaceutical companies to “come up with something that ...
Posted by Michael Wonder on 26 Aug 2020
Insights from the agenda for the November 2020 PBAC meeting
26 August 2020 - New gene therapy from Novartis the standout submission from version 1. ...
Posted by Michael Wonder on 26 Aug 2020
Drug industry lobbyists circulate two drug pricing proposals in hopes of warding off a Trump executive order
25 August 2020 - The pharmaceutical industry is weighing two drug pricing policies that it could offer as a trade ...
Posted by Michael Wonder on 26 Aug 2020
Agenda for the November 2020 PBAC meeting
26 August 2020 - The agenda for the November 2020 PBAC meeting is now available. ...
Posted by Michael Wonder on 26 Aug 2020
Cystic fibrosis drug could reduce severe disease, deaths if made available to Canadians
25 August 2020 - Talia D’Alessio has been living with cystic fibrosis since she was nine months old. ...
Posted by Michael Wonder on 26 Aug 2020
Knight and TherapeuticsMD announce Health Canada approval of Imvexxy
25 August 2020 - Knight Therapeutics and TherapeuticsMD announced today the approval of Imvexxy by Health Canada. In Canada, Imvexxy is ...
Posted by Michael Wonder on 26 Aug 2020
Sarepta Therapeutics announces FDA acceptance of casimersen (SRP-4045) new drug application for patients with Duchenne muscular dystrophy amenable to skipping exon 45
25 August 2020 - Received FDA's conditional approval of Amondys 45 as brand name for casimersen. ...
Posted by Michael Wonder on 26 Aug 2020
Metacrine announces MET409 receives FDA fast track designation for the treatment of NASH
25 August 2020 - Metacrine today announced that the U.S. FDA has granted fast track designation to MET409, the company’s lead ...
Posted by Michael Wonder on 25 Aug 2020
Imfinzi approved in Japan for the treatment of extensive-stage small cell lung cancer
21 August 2020 - Only PD-1/PD-L1 immunotherapy to demonstrate both a significant survival benefit and improved response rate in combination with ...
Posted by Michael Wonder on 25 Aug 2020
FDA accepts filing of new drug application for tepotinib for the treatment of patients with metastatic NSCLC with METex14 skipping alterations
25 August 2020 - Tepotinib granted priority review and is being evaluated under FDA Real-Time Oncology Review pilot program. ...