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Towards a solution for the access challenges faced by combination treatments
In this article, Takeda UK present their Value Attribution and Voluntary Arbitration Frameworks, a potential solution for the combination treatment challenge.
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Regs & Legs
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Product hub: Documentation at your fingertips
Digitalised Eppendorf products support customers on their way to a paperless lab whilst in compliance with good laboratory practice (GLP).
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Brochure: The new Sievers M500 online TOC analyser
The Sievers reagentless membrane conductometric TOC detection method delivers reliable, robust and accurate data for pharmaceutical water applications.
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NICE does not recommend tucatinib in new draft guidance
The UK regulator concluded that breast cancer patients taking tucatinib live longer, but it is unclear how long for and whether it is cost effective.
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Less than lifetime limits for N-nitrosamine mutagenic impurities
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
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CHMP initiates rolling review of molnupiravir for COVID-19
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
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Case study: Delivering a world class cell and gene therapy suite
RoslinCT and Connect 2 Cleanrooms have worked in partnership to deliver a world-class cell and gene therapy facility.
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FDA releases new guidance for drug and biological product data
The FDA has released new draft guidance: “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”
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Formulation, Development & Delivery In-Depth Focus 2021
Discover how to plan for post‑market clinical follow-up compliance under the new EU Medical Device Regulation (MDR), and formulate live biotherapeutic products to enhance their effects in this in-depth focus.
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Opdivo® approved in Europe to treat a range of cancers
Opdivo® (nivolumab) has been approved by the European Commission for gastric, gastroesophageal junction (GEJ), or oesophageal adenocarcinoma.
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European Pharmaceutical Review Issue 5 2021
Articles in this issue discuss the importance of diversity and inclusion in pharma, how packaging can improve big pharma's bottom line and why innovation has been vital to saving lives during the COVID-19 pandemic. Also in this journal, 10 key considerations when creating an ATMP manufacturing facility and how to…
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FDA sets up Novel Excipient Review Pilot Program
Manufacturers can submit their novel excipients for FDA review under the voluntary Novel Excipient Review Pilot Program.
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On-demand webinar: Spores in my cleanroom
This webinar considers the problems bacterial and fungal spores present for contamination control and remediation and disinfection strategies.
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Anti-amyloid antibody receives Breakthrough Therapy Designation in US
Roche's gantenerumab is an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients.
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EFPIA calls for harmonisation of GMO procedures in investigational drugs
The European Federation of Pharmaceutical Industries will implement a new regulation to co-ordinate genetically modified organism procedures.
