news
NICE recommends new treatment for EGFR-positive lung cancer
New therapy Mobocertinib, recommended by NICE, helps slow growth of EGFR-positive non-small-cell lung cancer in platinum-based chemo-treated patients.
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Regulation & Legislation
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GAMP 5 update: computerized system expectations for pharma manufacturers
The International Society of Pharmaceutical Engineering’s GAMP® 5 guidelines steer validation practices for pharma companies to meet computerized system expectations. Members of the GAMP steering committees, Lorrie Schuessler, Charlie Wakeham and Stephen Ferrell, share the some of the key changes in the second edition update and how these should be…
news
2022 WHO Biosimilar Guideline improves access, IGBA says
Under the revised 2022 WHO Biosimilars Guideline, IGBA says regulatory authorities can confidently revaluate biosimilar access requirements.
news
EMA human medicines committee (CHMP) highlights, November 2022
The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
news
Minoryx and Neuraxpharm team to provide new therapy for rare CNS disorders
Minoryx Therapeutics and the Neuraxpharm Group enter into a license agreement for the European rights to leriglitazone, which is currently under EMA review for the orphan indication X-linked Adrenoleukodystrophy (X-ALD).
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US legislative update: takeaways for European pharma
Keith A Zullow and Jenny J Zhang from Goodwin Procter examine upcoming US pharmaceutical regulation and how, if passed, it could impact European pharma/biopharma looking to access the US market.
news
NICE recommends pembrolizumab for breast cancer
Pembrolizumab is positively recommended for triple-negative early breast cancer, according to NICE final draft guidance.
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Breakthrough Therapy Designation for Pfizer bispecific antibody
A bispecific antibody for multiple myeloma gets Breakthrough Therapy Designation based on 61 percent overall response trial data.
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Could GSK offer the first RSV older adult vaccine?
The EMA has accepted a marketing application for an RSV vaccine intended for older adults, the first potential vaccine for this age group with lower respiratory tract disease.
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Case study: Reduce plate counting costs and delays
Learn how a US influenza vaccine manufacturer concerned with intermittent positive plate counts used rapid microbial monitoring to save time and money.
podcasts
EPR Podcast Episode 16 – Evolving QC for Cell & Gene Therapy – Félix Montero Julian and Thomas Jones, bioMérieux
What’s new in the cell and gene therapy landscape? What is the role of quality control in efforts to scale up manufacturing of CGT products and alleviate talent constraints? Find out more in this podcast with bioMérieux…
news
EMA’s PRAC confirms recommendation to withdraw amfepramones
The EMA’s safety board verifies that amfepramone-containing products for obesity should not be sold, due to higher-associated health risks.
news
Vaccine producers promise equal access in future pandemics
COVID-19 vaccine key players back a new proposal ensuring vaccines for future pandemics are equally distributed to all priority populations.
news
UK research consortium given £2 million to control monkeypox
£2 million will help fund a UK team of scientific experts to research monkeypox, uncover novel treatments and curb the spread of the virus.
whitepaper
Application note: Tipping point – what is driving the adoption of rFC for bacterial endotoxin testing?
As industry leaders seek strategies to build supply chain resilience, multi-sourcing is driving the adoption of alternative solutions like rFC.
