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 approves Tagrisso with the addition of chemotherapy for patients with EGFR mutated advanced lung cancer

12 July 2024 - Approval based on FLAURA2 results, which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...

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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 ...

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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 ...

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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.  ...

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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 ...

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FTC to sue drug managers over insulin prices

10 July 2024 - Antitrust agency is investigating how PBMs and manufacturers negotiate discounts. ...

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Australian children with neuroblastoma given free access to 500,000 dollar cancer drug DFMO

10 July 2024 - Australian children and young adults with neuroblastoma, a cancer that affects the nervous system, will be ...

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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 ...

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Pharma company lawsuit forces Dutch health agency to reassess cancer drug

9 July 2024 - The Dutch healthcare procurement agency has said it will reassess the breast cancer drug abemaciclib after ...

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Aplidin will be re-evaluated by the EMA. The European Commission revokes the decision that initially denied PharmaMar's marketing authorisation for multiple myeloma due to a conflict of interest.

8 July 2024 - The European Commission has acknowledged that an expert from the Scientific Advisory Group, who was developing a ...

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Outlook Therapeutics announces UK MHRA marketing authorisation of Lytenava (bevacizumab gamma) for the treatment of wet AMD

8 July 2024 - Initial commercial launches of Lytenava (bevacizumab gamma) in the EU and UK anticipated in calendar Q1, 2025. ...

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NICE recommends Ebglyss (lebrikizumab) for use in moderate to severe atopic dermatitis in the NHS England in eligible adolescents and adults

10 July 2024 - Following approval of the European Commission (October 2023) and the MHRA (December 2023), lebrikizumab will be available ...

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Updates to the HTA Policy and Methods Review

10 July 2024 - The Health Technology Assessment (HTA) Policy and Methods Review concluded on 4 May 2024. The HTA ...

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Mirum Pharmaceuticals’ Livmarli approved in the European Union for patients with progressive familial intrahepatic cholestasis

8 July 2024 - Mirum Pharmaceuticals today announced that the European Commission has granted marketing authorization for Livmarli (maralixibat) oral solution ...

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Lisocabtagene maraleucel for the treatment of adults with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma

10 July 2024 - NICE is unable to make a recommendation about the use in the NHS of lisocabtagene maraleucel (Breyanzi) ...

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