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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.

Biogen and AbbVie pull MS drug Zinbryta from the market

Biogen and AbbVie pull MS drug Zinbryta from the market

Escalating concerns about the safety of Zinbryta (daclizumab) - and particularly cases of liver damage and immune-related conditions - are behind the decision, which was announced on the same day that the ... Last November the EMA reported that it had

Latest news

  • Sanofi confirms suspected safety issue with dengue vaccine Sanofi confirms suspected safety issue with dengue vaccine

    Sanofi confirms suspected safety issue with dengue vaccine. As rival Takeda conduct phase II testing for its own dengue vaccine candidate. ... Prospects for Sanofi’s dengue fever vaccine Dengvaxia look increasingly dim after it confirmed a long-debated

  • Intercept hit hard as FDA issues Ocaliva safety notice Intercept hit hard as FDA issues Ocaliva safety notice

    Intercept hit hard as FDA issues Ocaliva safety notice. The PBC treatment has been linked to 19 deaths and 11 cases of liver damage. ... Intercept Pharma has only had a few months to revel in its first product launch before a safety warning from the FDA

  • MHRA and Swissmedic pledge greater collaboration MHRA and Swissmedic pledge greater collaboration

    MHRA and Swissmedic pledge greater collaboration. Product safety regulators to share information and promote international cooperation. ... international collaboration in addressing product safety concerns.

  • Teva suspends migraine patch on burn reports Teva suspends migraine patch on burn reports

    Teva suspends migraine patch on burn reports. FDA issues safety alert and instigates investigation into Zecuity. ... In addition to the suspension from sale, Teva is also carrying out a pharmacy level recall of Zecuity and patients are recommended to

  • Gilead files Complera follow-up with FDA Gilead files Complera follow-up with FDA

    TAF is more than 10 times more potent than its parent, so is associated with a more benign safety profile. ... treatment option with a favourable safety profile," said Norbert Bischofberger, the company's chief scientific officer.

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Latest Intelligence

  • 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

  • AI’s potential in the pharma life cycle AI’s potential in the pharma life cycle

    safety monitoring, artificial intelligence (AI) has substantial potential to change the way life sciences organisations operate. ... AI could also support a range of applications in product safety - for example, the use of algorithms to predict toxicity

  • Managed Access Programmes: a powerful source of real-world insight Managed Access Programmes: a powerful source of real-world insight

    These programmes therefore offer a unique opportunity to collect real-world data before launch, providing evidence to support the product's effectiveness, safety and value. ... Even simple points such as duration of treatment, reason for discontinuation,

  • Managed Access Programmes: a powerful source of real-world insight Managed Access Programmes: a powerful source of real-world insight

    These programmes therefore offer a unique opportunity to collect real-world data before launch, providing evidence to support the product's effectiveness, safety and value. ... Even simple points such as duration of treatment, reason for discontinuation,

  • The importance of real-world data to the pharma industry The importance of real-world data to the pharma industry

    For years, randomised controlled trials (RCTs) were considered the gold standard for generating clinical data on efficacy and safety to support product registration and subsequent prescribing. ... During the post-launch phase, RWD is used to demonstrate

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Latest appointments

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Latest from PMHub

  • 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.

  • The Heart of the Matter 9: Context is King

    But this is only the beginning of the discussion. “ Journal articles are the cornerstone of all communication around the safety and effi cacy of a product and the gold standard of ... Since the real-world population for a product will naturally differ

  • RSSL

    RSSL. RSSL is a specialist scientific consultancy providing unrivalled expertise in analysis, product development and training. ... We can help you achieve your commercial objectives in key areas such as product safety and innovation as well as meeting

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