news
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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Regulation & Legislation
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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…
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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.
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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.
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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.
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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.
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Make confident operational decisions by understanding your microflora
Are you leveraging all the information from your QC data? A secure, compliant and powerful data management tool is critical for maintaining a state of control.
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An Annex 1 and Pharma 4.0 perspective on water quality
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
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Patents: a necessary evil?
Dave Elder explores US patent developments amid growing concerns that current approaches potentially delay generic drugs and biosimilars entering the market.
news
EC approves CAR T-Cell therapy for B-cell lymphoma
Yescarta approved by EC for the treatment of large B-Cell lypmphoma and high grade B-cell lymphoma.
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CHMP recommends Pluvicto® for treating advanced prostate cancer
CHMP issues positive opinion on Pluvicto®, paving the way for it to become the first European-approved radioligand therapy for metastatic prostate cancer patients.
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NICE partners with health technology assessment bodies
Five health technology assessment (HTA) bodies will collaborate with NICE to help resolve regulatory and digital health technology challenges.
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Pilot to support ATMP research and development
Five academic and non-profit organisations developing advanced therapy medicinal products (ATMPs) will benefit from the European Medicines Agency’s (EMA) scheme.
