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The 10 latest FDA Orphan Drug Designations for cancer treatments
The FDA grants Orphan Drug Designation to treatments for rare diseases in R&D; here are the 10 most recent for oncologic conditions.
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Losartan drug recall expanded to include five more lots
FDA announces the voluntary recall for the losartan medications has been extended to include more lots, after impurities were found in the drugs.
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On-demand webinar: Customer Case Study: Adaptimmune Implementing a Paperless QC Micro Laboratory
Learn how Adaptimmune, a leader in developing T cell cancer therapies, implemented Lonza’s MODA™ Solution to manage information in QC micro lab more efficiently.
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CBD – the science behind purity
An event was held last week, exploring the manufacturing and potential of cannabinoids within the pharmaceutical industry.
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EMA CHMP recommends seven medicines for approval
The EMA has suggested seven treatments to be granted marketing authorisations and also advocated indication extension for eight drugs.
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Partnership between the BP and USP to be formalised
The British Pharmacopoeia and United States Pharmacopeia partnership is to be formalised to strengthen the quality of medicines and public health.
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Two lots of quinacrine recalled due to labelling error
Darmerica LLC is voluntarily recalling two lots of quinacrine dihydrochloride due to a label mix-up.
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New cancer drugs approvals underpinned by flawed evidence
A new report has shown that trial evidence alone is not enough when approving new cancer drugs and that an assessment of that evidence is also needed.
webinar
TOC fitness for purpose: How to ensure your TOC analyser is fit for compendial water & cleaning validation
19 September 2019 | By SUEZ
This webinar will present how to easily evaluate "fitness for purpose" of a TOC instrument for compendial water and cleaning validation applications based on USP and ICH Q2(R1).
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MHRA updates biologic quality guidance document
The UK Medicine and Healthcare products Regulatory Agency has released a revision to its standards for ensuring high quality of biologic products.
whitepaper
Whitepaper: The Gap Between LIMS Capabilities and QC Microbiology Needs
LIMS requires a high degree of customization to meet QC Microbiology requirements. This means LIMS implementations often lock users into a functionality set that can’t accommodate technology advancements and regulatory changes without considerable investments, time, effort and money.
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EMA to provide guidance on avoiding nitrosamines in medicines
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
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Three decades of pharmaceutical excellence: CPhI Worldwide
CPhI Worldwide will return for its 30th year on 5-7 November 2019 at Messe Frankfurt in Frankfurt, Germany.
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NDMA discovered in samples of ranitidine medicines
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
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FDA emphasises need for adverse event reporting of compounded drugs
The FDA says that even though it recognises the importance of compounded drugs, they also pose a risk to patient safety.
