news
Erenumab migraine drug fails to meet NICE recommendation standards
NICE has announced that it will not be recommending erenumab, an injectable migraine treatment, due to issues with cost and its long-term effectiveness.
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news
Sandoz voluntarily recalls ranitidine over NDMA contamination concerns
The probable carcinogen N-nitrosodimethylamine was detected in Sandoz’s ranitidine capsules, prompting the voluntary move.
news
FDA approves vaccine for smallpox and monkeypox
The Jynneos live, non-replicating vaccination for smallpox and monkeypox has been approved by the FDA for high-risk patients.
article
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.
news
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.
video
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.
news
CBD – the science behind purity
An event was held last week, exploring the manufacturing and potential of cannabinoids within the pharmaceutical industry.
news
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.
news
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.
news
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.
news
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).
news
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.
news
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.
