news
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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Regulation & Legislation
news
Oxford/AZ COVID-19 vaccine to be discontinued
Considering reduced global demand for COVID vaccines, AstraZeneca has deemed there is no long-term value in investing in manufacturing the adenovirus-based vaccine.
news
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).
news
NICE recommends new haemolytic anaemia treatment
The National Institute For Health and Care Excellence (NICE)'s decision follows a reduction in the price of Pfizer’s small molecule treatment for sickle cell disease.
news
MHRA publishes strategy on AI regulation
Incorporating artificial intelligence (AI) into the MHRA’s regulatory processes could help the agency focus on key priorities such as innovation.
whitepaper
Whitepaper: Molecular contamination control – odours, gases and toxics
Identify molecular contamination concerns in the pharmaceutical workspace and determine the right filtration solution for dealing with these problems.
whitepaper
Whitepaper: High-temperature filters for sterilization and depyrogenation processes
In sterilisation tunnels the need for filtration is of the utmost importance. Choosing the right filter can have an effect on production yield.
whitepaper
Booklet: Air Filtration – Upgrades without compromise
Learn how you can upgrade your filtration choices without compromising on energy performance.
news
CHMP meeting highlights: April 2024
In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
podcasts
EPR Podcast 24 – Developing modifier gene therapy – Ocugen
In this podcast, Dr Neena Haider, Faculty at Harvard Medical School and Dr Arun Upadhyay, Chief Scientific Officer at Ocugen, discuss the development of modifier gene therapy for ocular diseases.
news
Novel haemophilia B gene therapy approved
Pfizer has attained its first approval for a gene therapy from the US Food and Drug Administration (FDA), which is indicated to treat the rare blood disorder haemophilia B.
article
Under the microscope: Using recombinant reagents for BET
Veronika Wills, Associate Director, Global Technical Services at Associates of Cape Cod, Inc (ACC), discusses in-depth, motivations and strategies surrounding the use of recombinant reagents for bacterial endotoxin testing.
article
European Pharmaceutical Review Issue 2 2024
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
news
European Commission authorises one of first ustekinumab biosimilars in Europe
This approval follows a development and commercialisation agreement made in September 2023 between Sandoz and Samsung Bioepis for the biosimilar ustekinumab.
