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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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Therapeutics
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Pfizer to acquire Global Blood Therapeutics in $5.4bn deal
Through the acquisition of Global Blood Therapeutics, Pfizer aims to enhance its presence in rare haematology and particularly sickle cell disease (SCD).
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LAMP assays to enable rapid and sensitive detection of BCC
Here, EPR presents a novel loop-mediated isothermal amplification (LAMP) assay developed to enable the rapid and sensitive detection of Burkholderia cepacia complex (BCC) in pharmaceutical manufacturing.
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Big Pharma deal-making primed for acceleration
Subin Baral, Global Deals Leader, Life Sciences, Ernst & Young LLP, offers his predictions for M&A activity within industry as we head into the later stages of 2022.
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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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Global alliance to end childhood AIDS
New global alliance launched by UNAIDS, UNICEF and WHO aims to overcome “outrageous” disparities in the AIDS response and ultimately end AIDS in children by 2030.
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Litifilimab reduces skin disease activity in CLE trial
Phase II results suggest litifilimab safely and effectively reduces skin disease activity in cutaneous lupus erythematosus (CLE) patients.
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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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Microparticles could form self-boosting vaccines
New research suggests microparticles able to release their payloads at different times could form the basis of self-boosting vaccine courses that would require just a single injection.
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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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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…
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NA to NAM ratio as a biomarker for cell therapy sterility
Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
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Transpire Bio signs with Recipharm for inhaled medicine development
Under the agreement, Recipharm will help advance two inhaled medicines intended for asthma and chronic obstructive pulmonary disease (COPD).
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Grünenthal to buy NebidoTM testosterone treatment from Bayer for €500m
Privately-owned Grünenthal estimates the Nebido brand will add about €100 million to its EBITDA in 2023.
