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MHRA authorises new COVID-19 vaccine
The new COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) contains an adjuvant and is indicated to be given to patients over 16 years.
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UK Medicines and Healthcare products Regulatory Agency (MHRA)
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Breakthrough Therapy Designation for Pfizer bispecific antibody
A bispecific antibody for multiple myeloma gets Breakthrough Therapy Designation based on 61 percent overall response trial data.
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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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Developing a holistic approach to cardio, metabolic and renal disease
With cardiovascular disease continuing to present a significant health concern, European Pharmaceutical Review’s Hannah Balfour reflects on recent development efforts and drug approvals in the space with comment from Dr Douglas Clark, Head of Medical Affairs at Boehringer Ingelheim UK & Ireland.
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Menopause, contraception, endometriosis: are women’s health issues finally being recognised?
Despite recent progress in women’s health issues, there are still many challenges women continue to face when accessing healthcare. Here, Alison Slingsby of HRA Pharma discusses the recent advancements made in the UK and where further development is required.
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EU pharmaceutical regulatory outlook for 2022
How will a new regulatory landscape impact the EU and UK pharma industries? Early 2022 will see major new clinical trial legislation come into effect, with proposals for an entirely new regulatory regime promised by the end of the year. Paul Ranson, Consultant at Morgan Lewis, reflects on this and…
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Immuno-bridging studies are sufficient for authorising new COVID-19 vaccines, say regulators
The Access Consortium, comprising regulators from the UK, Australia, Canada, Singapore and Switzerland, announce that immuno-bridging studies can be used to support COVID-19 vaccine authorisation.
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UK life sciences sector: do you have the Vision for innovation?
Here, EPR explores some highlights of the UK’s new Life Sciences Vision for the pharma, biopharma and biotech industries, covering topics from funding to regulatory reviews and clinical trial innovation.
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MHRA and Health Canada release new clinical safety reporting guidance
Under the new guidance, Development Safety Update Reports must include a description of the process used to review the worldwide safety data of the investigational drug.
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New regulatory guidance could lead to UK biosimilar boom
New guidance on the licensing of biosimilar products that reduces unnecessary clinical trials is expected to put the UK ahead of Europe and facilitate a boom in these essential life-saving medicines, creating greater patient access and saving the National Health Service (NHS) hundreds of millions of pounds. It could also…
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Making use of those ‘in the know’
In this article, Aman Khera, the Global Head of Regulatory Strategy for Worldwide Clinical Trials, makes a case for regulatory involvement in drug development from start to finish and explains how the role of the regulator is changing, as well as what this means for pharma.
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UK and Europe approve Adtralza for treating atopic dermatitis
EU and UK regulators have approved Adtralza (tralokinumab), a monoclonal antibody, for treating moderate-to-severe atopic dermatitis in adult patients.
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Ten recommendations to foster the UK’s medicinal cannabis market
In this article, EPR summarises the list of 10 recommendations for the UK Government, published by experts in the medicinal cannabis industry, to ensure the UK capitalises on the opportunities afforded by the market.
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Balancing regulations for weighing in a GMP quality control laboratory
The importance of analytical balances in laboratory operations demands that they be fit for purpose over the operating range and acceptance criteria specified in the laboratory user requirements specification. In this article, Bob McDowall, Director of R D McDowall Limited, discusses the regulatory requirements for analytical balances operating in GMP…
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Novavax’ COVID-19 vaccine to be included in UK’s mixed regimen study
Novavax has agreed to participate in the University of Oxford’s Com-COV2 study evaluating the safety and efficacy of regimens consisting of doses of COVID-19 vaccines from different manufacturers.
