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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Diamyd Medical receives second US FDA fast track designation for Diamyd - for the prevention of type 1 diabetes

18 July 2024 - Diamyd Medical announced today that the US FDA has granted fast track designation for Diamyd (rhGAD65/alum) to ...

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Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease

17 July 2024 - PDUFA target action date of 15 January 2025. ...

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Orexo shares new information on OX124, a high dose naloxone rescue medication in development for opioid overdose

16 July 2024 - Orexo today announces that the company has received a complete response letter from the US FDA regarding ...

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BC doctor calls on the province to cover obesity medications

17 July 2024 - A petition from Dr. Ali Zentner asking for more PharmaCare coverage has received almost 1,000 signatures. ...

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Junshi Biosciences announces the acceptance of the supplemental new drug application for toripalimab combined with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma

17 July 2024 - Shanghai Junshi Biosciences announced that the National Medical Products Administration has accepted for review the supplemental new ...

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Transparent and complete reporting of surrogate endpoints in trials: the SPIRIT-Surrogate and CONSORT-Surrogate extensions

11 July 2024 - Randomised trials are resource-intensive studies that provide robust evidence for evaluating the effectiveness of interventions.  ...

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Rucaparib camsylate for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy

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

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Teclistamab for the treatment of patients with relapsed and refractory multiple myeloma after three or more treatments (review of previous guidance)

16 July 2024 - The Department of Health and Social Care has asked the NICE to review the guidance on ...

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Zilbrysq (zilucoplan injection) now approved for adults with generalised myasthenia gravis in Canada

17 July 2024 - Health Canada's approval is supported by the pivotal Phase 3 RAISE study in generalised myasthenia gravis in adult ...

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Diakonos Oncology receives FDA fast track designation for pancreatic cancer dendritic cell vaccine

15 July 2024 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the company’s unique ...

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Sellas announces US FDA rare paediatric disease designation granted to SLS009 for the treatment of paediatric acute myeloid leukaemia

16 July 2024 - Opened enrollment for paediatric AML patients in on-going Phase 2 clinical trial. ...

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ICER releases draft evidence report on treatments for transthyretin amyloid cardiomyopathy

17 July 2024 - Public comment period now open until 13 August 2024; requests to make oral comment during public ...

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Longeveron announces US FDA grants fast track designation for Lomecel-B for the treatment of mild Alzheimer’s disease

17 July 2024 - Second designation received for Lomecel-B for the treatment of mild Alzheimer’s disease after regenerative medicine advanced therapeutics ...

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Ocrelizumab approved as an injection to treat multiple sclerosis in adults

12 July 2024 - The MHRA has approved a new formulation of the medicine ocrelizumab (Ocrevus 920 mg solution for injection) ...

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CSL Behring announces positive reimbursement decision in Canada for Hemgenix (etranacogene dezaparvovec), the first gene therapy for haemophilia B

16 July 2024 - The positive decision from CADTH recognises the importance of this one-time, single dose innovative treatment for ...

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