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RSS FeedPosted 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. ...
Posted by Michael Wonder on 25 Aug 2020
Trump deadline for drug pricing order passes with no action
25 August 2020 - A deadline set by President Trump for moving forward with an executive order to lower drug ...
Posted by Michael Wonder on 25 Aug 2020
AbbVie aubmits regulatory application to FDA for Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis
25 August 2020 - In a pivotal Phase 2/3 study, twice as many patients receiving Rinvoq achieved the primary endpoint of ...
Posted by Michael Wonder on 25 Aug 2020
Recruitment begins to fill up to seven non-executive roles on the NICE board
25 August 2020 - Roles will contribute to the development of the NICE’s strategic objectives. ...
Posted by Michael Wonder on 25 Aug 2020
As COVID-19 pressures mount, political newcomer Stephen Hahn struggles to protect an FDA under siege
24 August 2020 - Stephen Hahn, a political novice who moved here in December to take over the FDA, has ...
Posted by Michael Wonder on 25 Aug 2020
Why are Trump and the Republicans so afraid of competition when it comes to drug prices?
24 August 2020 - President Trump recently signed two executive orders directly related to prescription drug prices in the U.S. ...
Posted by Michael Wonder on 25 Aug 2020
Over 200 medical professionals launch petition calling for better medication for bowel disease
24 August 2020 - A petition has been launched by over 200 medical professionals calling on PHARMAC to urgently fund ...