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RSS FeedPosted by Michael Wonder on 16 Jan 2020
Pharma execs pitch ideas at JPM20 to lower drug costs. None of them include dropping their own prices.
16 January 2020 - CEOs from the world’s largest pharmaceutical companies pitched ideas for lowering drug prices at the J.P. Morgan ...
Posted by Michael Wonder on 09 Jan 2020
Aruvant receives FDA rare paediatric disease designation for ARU-1801 for the treatment of sickle cell disease
8 January 2020 - ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and ...
Posted by Michael Wonder on 09 Jan 2020
New treatment approved in Canada for most common type of leukaemia
8 January 2020 - Calquence (acalabrutinib) is now available for adult patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. ...
Posted by Michael Wonder on 08 Jan 2020
Abuses of FDA regulatory procedures - the case of Suboxone
8 January 2020 - The manufacturer of brand-name buprenorphine products exploited various FDA regulatory procedures to impede market entry of generic ...
Posted by Michael Wonder on 08 Jan 2020
AMCP Format for Formulary Submissions, Version 4.1, includes new dossiers for submitting evidence on unapproved medicines and unapproved indications submitted for FDA approval
8 January 2020 - AMCP has released Version 4.1 of the AMCP Format for Formulary Submissions, which includes two new ...
Posted by Michael Wonder on 08 Jan 2020
Focus needed not just on drugs but hospital expenses to impact health care costs
8 January 2020 - Much is made of the cost of drugs in the U. S., a topic that is ...
Posted by Michael Wonder on 08 Jan 2020
Hospital overload ‘fuelled by GP rebate’
9 January 2020 - The Medicare rebate for GP consultations is too low, prompting tens of thousands of people each ...
Posted by Michael Wonder on 08 Jan 2020
ReNetX Bio receives fast track designation from U.S. FDA
8 January 2020 - Potential first-in-class therapy for chronic spinal cord injury. ...
Posted by Michael Wonder on 08 Jan 2020
Why Humira’s price keeps rising despite FDA approval of generic competition
8 January 2020 - The FDA has approved five generic versions of Humira — the world’s biggest-selling drug with global ...
Posted by Michael Wonder on 08 Jan 2020
FDA is grappling with digital health regulation
8 January 2020 - The Food and Drug Administration announced this week it will hold a public meeting in late ...
Posted by Michael Wonder on 08 Jan 2020
FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer
8 January 2020 - On January 8, 2020, the Food and Drug Administration approved pembrolizumab (Keytruda) for the treatment of ...
Posted by Michael Wonder on 08 Jan 2020
FDA – 2019 in review
8 January 2020 - Analysis of NDA approval timelines for 2019. ...
Posted by Michael Wonder on 08 Jan 2020
GOP Sen. Grassley turns to House Speaker Pelosi for help selling his bipartisan drug pricing bill
7 January 2020 - Grassley said Tuesday he wants to persuade Pelosi to support his bill, which he argues is the ...
Posted by Michael Wonder on 08 Jan 2020
PBAC – 2019 in review
8 January 2020 - The PBAC considered 188 submissions in 2019. ...
Posted by Michael Wonder on 08 Jan 2020
AbbVie receives Health Canada approval of Rinvoq (upadacitinib), an oral medication for the treatment of adults with moderate to severe active rheumatoid arthritis
7 January 2020 - Approval supported by efficacy and safety data from the pivotal Phase 3 SELECT rheumatoid arthritis program, one ...
Posted by Michael Wonder on 08 Jan 2020
Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for pemigatinib in patients with cholangiocarcinoma
7 January 2020 - Incyte today announced the validation of the Company’s marketing authorisation application for pemigatinib for the treatment of ...