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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Boehringer Ingelheim and GoodRx announce exclusive patient affordability initiative for adalimumab-adbm injection, Boehringer’s biosimilar to Humira

18 July 2024 - First biosimilar with an exclusive low cash price on the GoodRx platform. ...

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Why 10,000 Aussies a year being forced to fund their own cancer treatment

21 July 2024 - Australia’s medicine subsidy scheme is so crippled that a staggering 10,000 patients a year are being forced ...

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Neuren receives rare paediatric disease designation from FDA

19 July 2024 - Neuren Pharmaceuticals has received rare paediatric disease designation from the US FDA for NNZ-2591 in Phelan-McDermid ...

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EMA accepts Deciphera’s marketing authorisation application for vimseltinib for treatment of patients with tenosynovial giant cell tumour

18 July 2024 - Application based on results from the MOTION Phase 3 study, in which vimseltinib demonstrated statistically significant and ...

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Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the EMA

19 July 2024 - Regulatory submission supported by Phase 3 head to head DREAMM-7 and DREAMM-8 trials. ...

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Bristol Myers Squibb receives EMA validation of application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of unresectable or advanced hepatocellular carcinoma

19 July 2024 - The Application is based on Phase 3 CheckMate-9DW trial results demonstrating improved survival with Opdivo plus ...

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Phathom Pharmaceuticals announces FDA approval of Voquenza (vonoprazan) tablets for the relief of heartburn associated with non-erosive GERD in adults

18 July 2024 - Voquenza met its primary endpoint in its Phase 3 pivotal trial by demonstrating a significant and rapid ...

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Lexicon Pharmaceuticals receives 20 December 2024 PDUFA goal date for sotagliflozin type 1 diabetes NDA resubmission

16 July 2024 - Launch preparations actively underway; launch planned for early 2025. ...

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More than 40,000 people could benefit after NICE recommends new ‘take at home’ pill for advanced prostate cancer

19 July 2024 - A new pill to treat advanced hormone sensitive prostate cancer that could benefit just over 40,000 ...

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Public Summary Documents (first time decisions not to recommend and deferrals) - March 2024 PBAC meeting

19 July 2024 - The Public Summary Documents (first time decisions not to recommend and deferrals) from the March 2024 ...

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DUSC utilisation analysis public release documents (June 2024)

19 July 2024 - The utilisation analysis public release documents from the June 2024 DUSC meeting are now available. ...

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Outcome statement - June 2024 DUSC meeting

19 July 2024 - The outcome statement from the June 2024 DUSC meeting is now available. ...

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PHARMAC proposes to widen access to urinary tract infections treatment and fund a new epilepsy treatment

18 July 2024 - PHARMAC is consulting on improving access to treatment for urinary tract infections, as well as providing ...

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Bavarian Nordic receives EMA filing acceptance and validation of the MAA for its chikungunya vaccine

18 July 2024 - EMA will now initiate its centralised review procedure under accelerated assessment for Bavarian Nordic’s chikungunya vaccine. ...

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