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RSS FeedPosted by Michael Wonder on 17 Jul 2024
The Biden-Harris Administration releases final Part Two guidance to help people with Medicare prescription drug coverage manage prescription drug costs
16 July 2024 - The Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (CMS), continues ...
Posted by Michael Wonder on 16 Jul 2024
ICER publishes final evidence report on treatment for chronic obstructive pulmonary disease
16 July 2024 - Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ...
Posted by Michael Wonder on 16 Jul 2024
Arrivo announces FDA fast track designation for RABI-767 for patients with acute pancreatitis predicted to progress to severe disease
15 July 2024 - RABI-767 is a novel lipase inhibitor currently in a Phase 2a clinical trial. ...
Posted by Michael Wonder on 16 Jul 2024
Sumitomo Pharma announces that DSP-5336 has received FDA fast track designation for the treatment of relapsed or refractory acute myeloid leukaemia
15 July 2024 - -- Sumitomo Pharma today announced that the US FDA granted fast track designation to DSP-5336 for ...
Posted by Michael Wonder on 15 Jul 2024
Onco360 selected as a limited distribution specialty pharmacy partner for Rytelo (imetelstat)
12 July 2024 - Onco360 has been selected as a pharmacy partner by Geron Corporation for Rytelo (imetelstat) as a ...
Posted by Michael Wonder on 13 Jul 2024
Innorna announces US FDA rare paediatric disease designation granted to IN016 for the treatment of progressive familial intrahepatic cholestasis
11 July 2024 - Innorna today announced that the US FDA has granted rare paediatric disease designation to IN016, one of ...
Posted by Michael Wonder on 13 Jul 2024
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in giant cell arteritis
12 July 2024 - Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26 week ...
Posted by Michael Wonder on 13 Jul 2024
FDA grants fast track designation to 9MW2821 for the treatment of patients with locally advanced or metastatic nectin-4 positive TNBC
12 July 2024 - Mabwell announces that its self-developed novel nectin-4-targeting ADC (9MW2821) has been granted fast track designation by the ...
Posted by Michael Wonder on 12 Jul 2024
Incorporating real option value in valuing innovation: a way forward
10 July 2024 - Considerable progress has been made in defining and measuring the real option value of medical technologies. ...
Posted by Michael Wonder on 12 Jul 2024
AskBio receives FDA fast track and MHRA Innovation Passport designations for AB-1005 investigational GDNF gene therapy for Parkinson’s disease
11 July 2024 - Bayer AG and Asklepios BioPharmaceutical today announced that the US FDA has granted fast track designation ...
Posted by Michael Wonder on 11 Jul 2024
Novo Nordisk receives complete response letter in the US for once weekly basal insulin icodec
10 July 2024 - Novo Nordisk today announced that the US FDA has issued a complete response letter covering the ...
Posted by Michael Wonder on 10 Jul 2024
Obsidian Therapeutics announces FDA fast track designation for OBX-115 for the treatment of advanced melanoma
9 July 2024 - Obsidian Therapeutics today announced that the US FDA has granted fast track designation to OBX-115, a ...
Posted by Michael Wonder on 09 Jul 2024
FDA approves Arcutis’ Zorvye (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age
9 July 2024 - Commercial product expected to be available by the end of July. ...
Posted by Michael Wonder on 09 Jul 2024
Pharmacy middlemen appear to be inflating drug prices, FTC says
9 July 2024 - The Federal Trade Commission released a critical report detailing how pharmacy benefit managers—like CVS Health’s Caremark, Cigna’s ...
Posted by Michael Wonder on 09 Jul 2024
Adicet Bio receives FDA fast track designation for ADI-270 in metastatic/advanced clear cell renal cell carcinoma
8 July 2024 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-270 for the ...