Regulatory

MHRA approves Novartis treatment for CML  

20 June 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorisation to Novartis UK’s treatment for a specific type of cancer.  The authorisation was granted for Scemblix (asciminib), Novartis UK’s therapy for adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) who have previously been treated with two or more tyrosine […]

Animal research: reinventing the norm

9 May 2022

FRAME (Fund for the Replacement of Animals in Medical Experiments) Education and Outreach Manager Amy Beale discusses how current legislative and regulatory requirements for animal research could be strengthened to help prevent animal experiments and accelerate change. She also considers the factors influencing the lack of change within animal research. In complex human diseases such […]

What an EMA decision means for data-based regulatory submissions

4 May 2022

The European Medicines Agency (EMA) has confirmed that the UNICOM’s DADI (Digital Application Dataset Integration) project will now serve as a ‘Plan B’ for the implementation of regulatory data submissions. Amplexor’s Renato Rjavec looks at the opportunities and challenges this presents for pharma companies. A more data-driven way of managing regulated product data, based on […]

Five marketing strategies for ATMPs 

28 February 2022

The advanced therapy medicinal products (ATMPs) sector holds great promise. However, multidisciplinary strategies that begin early in the development process should be adopted, says Christian Schneider, head of Biopharma Excellence and Chief Medical Officer at PharmaLex. He outlines five strategies for avoiding pitfalls and boosting the success rates of development programmes.  SARS-CoV-2 and the successful development […]

AE reporting turnarounds and the translation issue 

18 November 2021

Listen to this article on the DDW Podcast:   The workload in pharmacovigilance (PV) is soaring and as new vaccines and medications enter the market, it’s crucial to track adverse events (AE). As AE reports still have to be filed within 24 hours, Kathleen O’Brien of Amplexor Life Sciences lays out a blueprint for centralising global AE reporting.  AE notifications come in […]

Ex-MHRA scientist leads powerhouse trio’s new biopharma excellence brand 

14 October 2021

PharmaLex Group has announced the launch of a new service line, Biopharma Excellence, and the appointment of ex-MHRA scientific lead Dr Christian Schneider as its Chief Medical Officer.   Biopharma Excellence is a fusion of three scientific organisations, PharmaLex, ERA Consulting and Biopharma Excellence, under the PharmaLex brand. The new service line combines 35+ years of empirical experience and respected regulator […]

Health Canada approves Moderna, Pfizer and AstraZeneca vaccines 

23 September 2021

Health Canada has approved Moderna’s New Drug Submission (NDS-CV) for Spikevax (elasomeran mRNA vaccine), it has granted full approval (Notice of Compliance or NOC) for Pfizer’s Comirnaty, and it has approved the AstraZeneca vaccine, which will be named Vaxzevria.  “Health Canada’s approval of our Covid-19 vaccine is an important milestone as it is our first full approval for Spikevax. I […]

FDA vs EMA: biotechs & the challenges of international pharmacovigilance

12 August 2021

Biotechs involved in drug discovery have to navigate increasingly complex regulatory environments across borders. Experienced experts and non-executive advisors to Arriello, Eric Caugant in Paris and Judi Sills in New Jersey highlight the main differences between US and EU requirements, and advise on best preparations. Small biotech companies are commanding an increasingly prominent role in […]

How will UK life sciences vision impact medicine development and research?

7 July 2021

The new UK Life Sciences Vision, developed with businesses and experts in the field, outlines seven critical missions that government, industry, the NHS, academia and medical research charities will work together on at speed to solve – from cancer treatment to tackling dementia. These missions will focus on preventing, diagnosing, monitoring and treating disease early, […]

Virtual and augmented reality – expanding data insights

22 April 2021

Insights from data hold the key to understanding how effectively companies are operating and to making connections that lead to discovery and innovation. Recently, software solutions have got better at providing graphical dashboards that help decision-makers visualise their data. In the near future, virtual or augmented reality (VR/AR) technology will do much more to uncover […]

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