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RSS FeedPosted by Michael Wonder on 03 May 2018
White House drug price initiative to include negotiation tools, list prices, Azar says
2 May 2018 - HHS Secretary Alex Azar revealed Wednesday that the White House's impending drug pricing strategy will include ...
Posted by Michael Wonder on 03 May 2018
For expensive new drugs, biopharma should make money-back guarantees mandatory
2 May 2018 - In a recent paper on “Value-Based Pricing for Drugs”, authors Anna Kaltenboeck and Peter B. Bach of ...
Posted by Michael Wonder on 03 May 2018
FDA updates Trintellix (vortioxetine) label to include data showing improvement in processing speed, an important aspect of cognitive function in acute major depressive disorder
2 May 2018 - Trintellix (vortioxetine) is the first FDA-approved treatment for MDD to have data in the U.S. Prescribing Information ...
Posted by Michael Wonder on 03 May 2018
Migraine drug delay would compound Teva's troubles
2 May 2018 - Teva Pharmaceutical Industries is counting on its new migraine treatment to haul it out of the ...
Posted by Michael Wonder on 03 May 2018
Cellectar receives rare paediatric disease designation for CLR 131 to treat neuroblastoma
2 May 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to the ...
Posted by Michael Wonder on 03 May 2018
RegenxBio receives FDA fast track designation for RGX-121 gene therapy for the treatment of mucopolysaccharidosis Type II
2 May 2018 - Phase I/II clinical trial expected to enrol children with MPS II. ...
Posted by Michael Wonder on 02 May 2018
President Trump wants to go 'much further' to attack high drug prices, HHS secretary says
2 May 2018 - President Trump has repeatedly attacked drug companies for "getting away with murder" on prices. ...
Posted by Michael Wonder on 02 May 2018
Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab
2 May 2018 - Sandoz, a Novartis division, announced today that the US FDA has issued a complete response letter ...
Posted by Michael Wonder on 02 May 2018
FDA releases Theratechnologies from post-approval commitments related to Egrifta (tesamorelin for injection)
1 May 2018 - Theratechnologies today announced that the FDA has released Theratechnologies from post-approval commitments related to the approval ...
Posted by Michael Wonder on 01 May 2018
Acceleron receives FDA fast track designation for ACE-083 in facioscapulohumeral muscular dystrophy
1 May 2018 - Acceleron Pharma today announced that the U.S. FDA has granted fast track designation to ACE-083, a ...
Posted by Michael Wonder on 01 May 2018
Scynexis' oral SCY-078 receives FDA QIDP and fast track designations for the treatment of VVC and prevention of recurrent VVC
1 May 2018 - Enrollment completed in Phase 2b DOVE study in VVC; on-track for top-line data by July 2018. ...
Posted by Michael Wonder on 01 May 2018
Kymriah (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphoma
1 May 2018 - Kymriah is the only CAR-T therapy FDA-approved for two distinct indications - in non-Hodgkin lymphoma (NHL) and ...
Posted by Michael Wonder on 01 May 2018
Regeneron/Sanofi cut heart drug price to $4,500-$6,600 for Express Scripts
1 May 2018 - Regeneron Pharmaceuticals Inc and Sanofi SA will slash the price of their expensive cholesterol drug for Express ...
Posted by Michael Wonder on 01 May 2018
As specialty drugs gain share, Trump looks to curb prices
1 May 2018 - The share specialty drugs have of total U.S. pharmaceutical sales is hurtling toward 50% just as ...
Posted by Michael Wonder on 01 May 2018
The ICER appoints new members to each of its three independent evidence appraisal councils
1 May 2018 - New members bring expertise in broad range of perspectives, including health policy, economics, and clinical practice. ...