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MHRA
This page shows the latest MHRA news and features for those working in and with pharma, biotech and healthcare.
UK to introduce new regulatory framework for point of care manufacturing
The announcement follows a public consultation carried out by the MHRA, in which respondents highlighted the urgent need to establish a regulatory framework for POC products. ... The MHRA said it will also begin to develop guidance, together with
Latest news
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BeiGene’s Brukinsa receives FDA approval for chronic lymphocytic leukaemia
Brukinsa was most recently granted two new marketing authorisations by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of CLL, as well as for patients with marginal zone ... The MHRA authorisation for MZL – a group of
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BeiGene’s Brukinsa granted two new marketing authorisations by MHRA
BeiGene’s Brukinsa (zanubrutinib) has been granted two new marketing authorisations by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of chronic lymphocytic leukaemia (CLL) and for patients ... The MHRA’s decision on
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Valneva reports additional data for COVID-19 booster
once again confirm the favourable safety and tolerability profile of VLA2001, which was important for European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) approval.”.
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MHRA set to receive nearly £1m from BEIS’ Regulator’s Pioneer Fund
The Medicines and Healthcare products Regulatory Agency (MHRA) has received a total of £970, 688 from the Department for Business, Energy and Industrial Strategy’s (BEIS) Regulators’ Pioneer Fund. ... One of the MHRA’s central aims is to focus on
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MHRA approves LEO Pharma’s Adtralza for adolescent patients with atopic dermatitis
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved to the extend the terms of the marketing authorisation for LEO Pharma’s Adtralza (tralokinumab) to include the treatment of adolescent
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Latest Intelligence
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Unlocking the potential of data sharing
The UK, and the worldwide, clinical trials industry was already complying with most of the GDPR requirements due to strict regulatory requirements (including the FDA, MHRA, PMDA, ICH, GCP, etc) before ... Looking ahead, advances in clinical protocol
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The future of medtech is in the past
An approved notified body is an organisation designated by the Medicines and Healthcare products Regulatory Agency (MHRA) to assess whether manufacturers and their devices meet the requirements set out in the
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Transforming clinical trials to accelerate drug development
the MHRA, and welcome the shift they are initiating towards a more streamlined, combined review. ... Beyond the MHRA, regulatory agencies across the world have also recognised the importance of innovations in trial design.
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How early-stage clinical research is facilitating the new wave of personalised medicines
The MHRA has also adapted its processes to support the rapid development and uptake of precision therapies. ... The MHRA has shown a willingness to understand the unique nature of gene therapy studies and they have shown flexibility and speed when
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Patient diversity in clinical trials needs to be centre stage
Regulatory pressure, particularly from the FDA and more recently by the MHRA and EMA, is encouraging inclusivity and diversity, she added.
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Latest appointments
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NDA Group appoints Alison McGregor as its principal consultant
She has over 20 years’ experience in the pharmaceutical sector working for both industry and regulatory agencies including AstraZeneca and the UK’s MHRA.
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PharmaLex appoints Zabin Younes as associate director
In addition she also has over ten years of management experience and has set up and managed research teams, GMP testing laboratories and led MHRA/FDA corporate audits.
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Dr Gopalan Narayanan joins VCLS
With a focus on advanced therapies and other biologics, he was at UK medicines regulator the MHRA for nearly 12 years as an expert medical assessor and during that time spent
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Dr June Raine continues as chair of EMA's pharmacovigilance committee
Dr Raine is director of vigilance and risk management of medicines at the Medicines and Healthcare products Regulatory Agency (MHRA) and has served as PRAC chair since it was set up
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New health ministers and re-appointments after reshuffle
Freeman's role is also tied into the Department for Business, Innovation and Skills and includes expanded responsibility for the Cancer Drugs Fund, NICE and MHRA, research and development, issues around
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Latest from PMHub
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Using ethnography to uncover the authentic patient experience
There’s also the regulatory side of things too. A number of the leading regulatory bodies in the world now, including the FDA in the US and the MHRA in the
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How marketers are balancing the changing trends in women's health
Published December 23, 2021. Accessed March 29, 2022. Lucy Parsons. MHRA approves over-the-counter contraceptive pill.
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Key barriers to effective patient engagement in pharma, and how to fix them: Making engagement processes more patient friendly
Working with regulatory bodies to enable easier collaboration while maintaining patient safety. Both the ABPI and MHRA in the UK are demonstrating how they value patient engagement by launching their own
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Is COVID-19 yet another barrier to contraceptive access?
So far, one of the biggest moves made to combat this issue was the approval of two over-the-counter contraceptive pills by the MHRA.
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WHITE PAPER: From bench to bedside in one year - how the race for a COVID-19 vaccine will change the future of drug development
example, the Medicines and Healthcare Products Regulatory Agency (MHRA) have invested in efforts to use artificial intelligence (AI) in order to improve the process of reporting adverse events, which hopefully could
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- World Health Organization releases latest set of COVID-19 guidelines
- BeiGene’s Brukinsa receives FDA approval for chronic lymphocytic leukaemia
- AstraZeneca/Daiichi Sankyo’s Enhertu approved by EC for advanced breast cancer
- Eli Lilly announces $450m investment in US manufacturing site
- Europe’s cancer community publishes new report on transforming patient care
- EU outlines measures to mitigate antibiotic shortage across Europe
- Innovative Trials comments on extra funding to increase access to clinical trials for cancer patients
- Gilead’s CAR-T cell therapy recommended by NICE for lymphoma
- JCVI recommends autumn COVID-19 vaccine booster for those at highest risk
- MIT researchers develop AI model to detect future lung cancer risk
- Merging global and local pharmacovigilance operations into a successful integrated approach
- Diversifying Healthcare AI with Federated Learning
- FDA and CDC investigate potential safety concern for Pfizer/BioNTech’s COVID-19 vaccine
- World Health Organization releases latest set of COVID-19 guidelines
- AbbVie and Eli Lilly leave UK’s voluntary drug pricing agreement
- EU to revise pharmaceuticals law amid antibiotic shortages
- European MPs call for urgent action against antimicrobial resistance
- The role of medical communications in building credibility for healthtech
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