Medical Devices Regulation: delays and confusion
The EU Medical Devices Regulation will apply in May 2020. Maurits Lugard and Josefine Sommer of Sidley Austin LLP examine what the changes mean for the medtech industry.
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The EU Medical Devices Regulation will apply in May 2020. Maurits Lugard and Josefine Sommer of Sidley Austin LLP examine what the changes mean for the medtech industry.
As companies continue to collaborate and share their expertise to develop therapeutics targeting a wide range of diseases, European Pharmaceutical Review explores the aims of the most recent partnerships.
A novel formulation for dolutegravir has been developed to improve HIV treatment options for children. Dr Kimberly Smith from ViiV Healthcare discusses the benefits of this new dispersible tablet.
Following 250 US drug price increases in 2020 already, this article explores why costs are rising, what changes could ensure brand reputations remain intact and what manufacturers can do to ensure they get their share.
The pharmaceutical industry saw some notable mergers and acquisitions in 2019; this article lists the top 10 by transaction size.
The EMA was a proactive force in 2019, granting marketing authorisation for a range of drugs. This article highlights some of the most important advancements made by the agency last year.
Health authorities in Dubai have announced that they will introduce a new track and trace system to the emirate by mid-2020. This article investigates how this will help to improve the safety and quality of medicinal products.
A proof-of-concept nanorobot design could be used to target cancer cells by their glucose consumption and deliver a drug payload in response to tumour interaction.
Several organisations have developed guidelines that specifically address genotoxic impurities in pharmaceutical products. Here, Dr Sol Bobst and Gowri Sukumar discuss the regulatory landscape, testing requirements and calculation methods for occupational exposure limits.
Clinical microbiologists have started using new, non-conventional methods to study the microbiology of the human gut. In this article, Jeanne Moldenhauer discusses the intricacies of culturomic and metagenomic studies and how this can advance current research.
Since it was discovered in the 1920s, Raman spectroscopy has been used in pharmaceutical research as a non‐invasive way to provide chemical and structural information in situ, without any staining or complicated sample preparation. Nikki Withers spoke to Professor Kishan Dholakia to hear more about its use in industry and…
Faced with the looming deadline for compliance of May 2020, many medical device companies still haven’t fully grasped the impact of the new EU Medical Device Regulations (MDR) across all their product labelling. The requirements also affect what goes on Information-for-Use (IFU) leaflets and electronic equivalents. Here, Graham Francis offers…
Drug safety is a huge concern for big pharma and tampering and counterfeiting in the market is dangerous for both consumers and brands. In this article, Prakash Shetty shares the latest innovations in packaging design and highlights how tamper proofing and developments in technology can protect all concerned.
Mergers and acquisitions in any market can define the landscape for its players. In this article, Emma Danks of Taylor Wessing reflects on recent M&A activity in the biopharmaceutical industry, highlighting influencing trends and what this might mean for the future.
The first gene therapy products are appearing commercially and the field is growing rapidly with over 350 clinical trials taking place in H1 of 2019 alone. So why is this area attracting so much attention? Dr Philip Probert and Dr Stuart Jamieson discuss the potential of gene therapy and the…