news
FDA approves Zynteglo gene therapy for beta-thalassemia patients
bluebird bio’s Zynteglo (betibeglogene autotemcel), a one-time treatment for transfusion-dependent beta-thalassemia, will roll out with a $2.8mn price tag per dose.
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Regulation & Legislation
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Tackling the silent pandemic: AMR Industry Alliance sets the Standard
Here AMR Industry Alliance representatives Melissa Gong Mitchell and Steve Brooks discuss how the Alliance is mobilising the life sciences sector in combatting antimicrobial resistance (AMR). They present the newly established antibiotics manufacturing standard that aims to minimise pharma’s contribution to AMR in the environment, considering the critical considerations and…
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UK approves Moderna’s bivalent COVID-19 vaccine
MHRA approves Moderna’s adapted COVID-19 vaccine, Spikevax bivalent Original/Omicron, for use as a booster.
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Monkeypox update – August 2022
In this article, EPR’s Hannah Balfour discusses the recent multi-country monkeypox outbreak, highlighting key developments in the international response.
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UK recall of Clinigen’s Mexiletine hydrochloride hard capsules
A Class 1 Medicines Recall Notification has been issued for three batches of Mexiletine hydrochloride hard capsules due to potential for under- or overdosing.
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Pharmacopoeias to further support vaccine development and supply
US and European Pharmacopoeias announce new activities to help promote vaccine development, manufacturing, quality and supply.
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ViiV agrees to expand access to long-acting HIV PrEP
Under a new agreement, licenced manufacturers will be able to supply generic versions of ViiV’s long-acting cabotegravir HIV pre-exposure prophylaxis (PrEP) medication to developing nations.
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Big Data Steering Group to enhance data quality and discoverability under new workplan
The Group plans to deliver a data quality framework by the end of 2022 and publish a public catalogue of European real-world data by 2025, among other actions.
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Bristol Myers Squibb aims to improve disability diversity in clinical trials
Bristol Myers Squibb is collaborating with non-profit organisation Disability Solutions on an initiative to increase diversity in clinical trials.
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Regulators commit to collaborating on RWE integration
Global regulators commit to collaborate on the integration of real-world data and real-world evidence (RWE) in regulatory decision-making.
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CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
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EU proposes new blood, tissues and cells Regulation
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
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Tackling fake pharmaceuticals: an industry united against counterfeit products
The market for counterfeit pharmaceutical products remains strong, with dishonest actors proving perennially tenacious. Here, Rich Quelch offers guidance on the technologies and practices that are helping to impede fraudsters.
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How can evidence-based medicine (EBM) methodology support drug withdrawals?
In this article, Samantha Lane of the UK’s Drug Safety Research Unit discusses the development of an evidence-based medicine (EBM) methodology to assess the positive impact of withdrawing or revoking licences for medicines on public health. The approach leverages electronic health records to model the estimated number of adverse reactions…
video
Video: Free 10-minute pharma data integrity training
Ex-MHRA inspector and NSF expert, Rachel Carmichael, takes a high-level look at why Data Integrity matters in this online introduction training.
