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Pharma Horizons: Cell and Gene Therapy
This report is dedicated to exploring some of the latest innovations in the cell and gene therapy space, from development and quality control, through to manufacturing and clinical trials.
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Regs & Legs
news
Two novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
podcasts
EPR Podcast 25 – FAIR Data in Pharma – Giovanni Nisato, Pistoia Alliance
In this podcast, Giovanni Nisato, Project Manager at the Pistoia Alliance discusses data integrity and the progress towards implementation of FAIR data principles in the pharmaceutical industry.
news
European Commission grants first-of-a-kind biosimilar approval
The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.
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ICH Q14 – latest guideline on analytical procedure development
Here, Dave Elder delves into the newly issued ICH Q14 guidance on analytical procedure development, discussing its impact during commercial phases as well as clinical development.
news
European authorities recognised for leading medicine regulatory oversight
Expansion of the WLA framework means that the largest number of regulatory agencies for medical products are approved as WHO Listed Authorities.
news
UK clinical trial regulation may support haemophilia treatment access
The new Notification scheme by the MHRA helps to reduce the time it takes for the lowest-risk clinical trials to commence, while maintaining patient safety.
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Effective data quality governance: challenging five common myths
It is a well-established expectation that regulatory processes will become increasingly data focused, which places a new urgency on data quality governance in the pharmaceutical industry. In this Q&A Steve Gens and Preeya Beczek present a pragmatic view of what is involved.
news
EMA recommends suspension of hydroxyprogesterone caproate medicines
The recommendation comes after studies raised possible safety concern and found 17-OHPC is not effective in preventing premature birth.
news
FDA approves Amgen T-cell engager for small cell lung cancer
Amgen’s Imdelltra™, previously known as tarlatamab, is approved for the treatment of adult patients with advanced small cell lung cancer.
article
Advancements and knowledge gaps in ICH Q2(R2)
In this article, Amanda Guiraldelli Mahr, Joachim Ermer, Jaime Marach, Phil Borman and other members of USP’s Analytical Procedure Lifecycle Joint Subcommittee explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. The authors also identify areas that would benefit from additional guidance and compare…
news
Impact of EU sustainability directive on supply chains
Pharmaceutical and healthcare companies have shared how they expect the new EU supply chain laws could impact their operations.
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mRNA cancer vaccine granted world-first approval
Once commercialised, the mRNA therapeutic cancer vaccine will offer a new option to treat advanced Epstein–Barr virus-positive solid tumours and haematologic malignancies.
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US agencies collaborate to address regulation for biotechnology products
In formulating the current Coordinated Framework for the Regulation of Biotechnology, the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA) utilised horizon scanning for novel biotechnology products.
news
MHRA approves new medicine formulations for HIV prevention
The authorised formulations are a tablet and a long-acting injection used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis (PrEP).
