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product safety

This page shows the latest product safety news and features for those working in and with pharma, biotech and healthcare.

FDA approves Rigel’s Rezlidhia for acute myeloid leukaemia

FDA approves Rigel’s Rezlidhia for acute myeloid leukaemia

In terms of safety, the company reported Rezlidhia was well tolerated, with an adverse event profile characteristic of symptoms or conditions experienced by patients with AML undergoing treatment. ... it intends to work with potential partners to further

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  • CAR-T cell therapy in oncology CAR-T cell therapy in oncology

    Without a sufficiently flexible and redundant design, changing schedules at any point during collection, manufacturing, shipping and delivery can affect the entire workflow, potentially compromising patient and product safety. ... Common safety signals

  • Pre-launch planning and DSLs – the new ways to create launch excellence in pharma Pre-launch planning and DSLs – the new ways to create launch excellence in pharma

    o What are the product benefits? (untreated disease, efficacy, safety, price). ... efficacy, safety, pricing, medicine administration). Test messaging and language. o Engage and learn from the online community (without mentioning your product).

  • Achieving an agile supply chain Achieving an agile supply chain

    Customer expectations with regards to product safety and hygiene are also creating new trends within product packaging, trends which reverse the shift away from plastic that has occurred over recent years. ... Andy Barrett is Senior Product Manager at

  • Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe

    While Onpattro has outshone Ionis’ product in safety and efficacy, analysts see Onpattro’s lack of cardiovascular claims in its US label as a weak point. ... and sustainable clinical pipeline and a robust product engine by the end of 2020; a company

  • Biologic or biosimilar: what are prescribers thinking? Biologic or biosimilar: what are prescribers thinking?

    Provenance and product availability matter: Even with proven safety and efficacy, the origins of some biosimilars raise questions. ... Many companies (eg, from Asia) are unknown, and uncertainties around delivery capabilities and safety legislation

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  • UNDERSTANDING THE NEW VALUE PROPOSITION FOR THE NHS UNDERSTANDING THE NEW VALUE PROPOSITION FOR THE NHS

    Any proposition must therefore continue to describe things like the clinical efficacy, safety and patient benefits of a product, the costed benefits it can bring to a given service, and how ... Conclusion. In short, Industry must now broaden its

  • Real-world evidence: breaking boundaries in rare disease

    The generation of data to show the significant benefits of a drug has always been a complex, intricate process, but essential to ensure a product’s approval, support the overall value ... Traditional randomized clinical trials (RCTs) are considered the

  • The story behind Chloe Mitchell

    What attracted you to the Medical Communications industry? In my previous role in Patient Safety, my knowledge was product specific and I felt that Medical Communications would give me a broader ... My previous role in patient safety required 6–9

  • A Bitter Pill?

    product profiles, and getting it right is fundamental to a product’s eventual uptake and market share. ... In conclusion, optimising the route of admin is a fundamental step in the path to market for any pharmaceutical product.

  • Using new technologies to capture the patient's voice

    world evidence that enables them to continue appraising the safety, efficacy and value of medicines over their full lifecycle. ... time. Trust (embracing such factors as perceived lack of transparency and product safety concerns), meanwhile, was

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