Johnson & Johnson, BMS fight US drug price plan at Third Circuit

16 July 2024 - Pharmaceutical giants Johnson & Johnson, BMS and AstraZeneca are rejecting federal district court decisions that rule ...

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Health Canada authorizes Alecensaro (alectinib) as the first and only adjuvant treatment for people with ALK positive early stage lung cancer

16 July 2024 - Alecensaro reduced the risk of disease recurrence or death by 76% in people with ALK positive resected ...

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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 ...

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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 ...

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Elranatamab for the treatment of patients with relapsed and refractory multiple myeloma after three or more treatments

12 July 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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SMC - July 2024 decisions

 8 July 2024 - Voretigene neparvovec (Luxturna) was accepted for the treatment of adults and children with an extremely rare inherited ...

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AusperBio receives breakthrough therapy designation for AHB-137 in chronic hepatitis B treatment

10 July 2024 - AHB-137 gains breakthrough therapy designation from the NMPA based on Phase 1/Phase2a clinical trial data demonstrating safety ...

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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. ...

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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 ...

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Doug Ford wants Canada to approve drugs faster. Is that possible?

15 July 2024 - Talk of the delay in drugs is top of mind for Ford, who arrived in Nova Scotia ...

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Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for people with cystic fibrosis aged 2 years and older with certain rare mutations

15 July 2024 - Approximately 200 people with certain rare CF mutations are now eligible for Trikafta. ...

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Clinical benefit, reimbursement outcomes, and prices of FDA approved cancer drugs reviewed through Project Orbis in the USA, Canada, England, and Scotland: a retrospective, comparative analysis

11 July 2024 - Project Orbis is a global initiative that aims to streamline regulatory review processes across international regulators in ...

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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 ...

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PHARMAC proposal to increase access to five medicines for cancer and other health conditions

12 July 2024 - PHARMAC is looking to increase access to five medicines for a number of cancers, including kidney ...

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Fresenius announces EMA validation of marketing authorisation application for denosumab biosimilar candidates

11 July 2024 - Fresenius, via its operating company Fresenius Kabi, announced that the EMA has accepted for review the company’s ...

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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 ...

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