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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.

Advaxis shaken by another FDA hold on cervical cancer vaccine

Advaxis shaken by another FDA hold on cervical cancer vaccine

The FDA hasn't cited any safety issues on this occasion, and enrolled patients will continue to receive treatment, but no new patients can enroll in AIM2CERV until the partial hold ... concluded, “Our Axal product has demonstrated a manageable safety

Latest news

  • 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

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

    Prospects for Sanofi’s dengue fever vaccine Dengvaxia look increasingly dim after it confirmed a long-debated safety issue with the product.

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

    Intercept Pharma has only had a few months to revel in its first product launch before a safety warning from the FDA knocked it back. ... The US regulator issued a safety notice yesterday warning that the company's Ocaliva (obeticholic acid) for primary

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

    Product safety regulators to share information and promote international cooperation. From left: Swissmedic's Jürg Schnetzer and MHRA's Dr Ian Hudson. ... The UK's Medicines and Healthcare products Regulatory Agency (MHRA) and its Swiss counterpart

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

    FDA issues safety alert and instigates investigation into Zecuity. Teva has withdrawn its migraine patch Zecuity from the market just a few months after launch, following reports that it may cause ... In addition to the suspension from sale, Teva is

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Latest Intelligence

  • 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

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

    patient 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

  • 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,

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Latest appointments

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Latest from PMHub

  • A Bitter Pill?

    commonly find that route of admin is often one of the first features they take into account (after efficacy and safety) when reviewing product profiles, and getting it right is fundamental ... In conclusion, optimising the route of admin is a fundamental

  • 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

  • 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 the

  • United BioSource Corporation

    We help generate authoritative, real-world evidence of product effectiveness, safety and value to assist health care decisions and enhance patient care.

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Fishawack Group of Companies

The Fishawack Group of Companies is one of the largest independent medical communications and medical marketing specialists, with teams in...

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