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Technical bulletin: Nitrosamines: Questioning the current analytical approach
We look at the challenges posed in regards to nitrosamine testing methodologies and the way in which to move forward to ensure safer drug products.
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Regulation & Legislation
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EU’s Medical Device Regulation is now applicable
Europe’s Medical Device Regulation is now applicable to medicines with an integral device, devices containing an ancillary medicinal substance and several other products.
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Europe approves Ponvory (ponesimod) for multiple sclerosis
The European Commission has approved once daily oral Ponvory (ponesimod) for the treatment of relapsing multiple sclerosis in adult patients.
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EMA’s human medicines committee (CHMP) meeting highlights, May 2021
In its latest meeting the CHMP recommended eight medications for approval, 17 medicines for indication extension and concluded reviews of two COVID-19 treatments.
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Quality assurance and data integrity from an auditors’ viewpoint
21 May 2021 | By Thermo Fisher Scientific
In this on-demand webinar, you will hear directly from industry auditors as they discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation and qualification for computerised systems in regulated laboratories.
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Curative cell and gene therapies and healthcare system disruption
In this article, experts from Charles River Associates discuss how the introduction of cell and gene therapies will impact upon various aspects of the healthcare system, from provision of care to delivery and supply, and pricing and market access.
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FDA issues draft guidance on trials for medical devices to improve glycaemic control
The guidance outlines recommendations for early trials testing the feasibility of medical devices intended to improve glycaemic control for type 2 diabetes.
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UK patients with rare blood disorders receive new treatment option
NICE has recommended that Ultomiris (ravulizumab) be available on the NHS for patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.
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News: Endotoxin automation is achieved with microfluidics for simple, compliant BET
Automated endotoxin testing is achieved in a compact platform, leveraging microfluidic liquid handling. QC labs simplify BET with easier, compliant assays using less LAL.
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Case study: New trends: reducing GWP impact on GMP freeze drying processes
How to turn an older refrigeration system in an existing freeze-dryer into a new environmentally friendly cooling system.
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Driving biopharma innovation post COVID-19
Ahmed Bouzidi, VP of Biotech Strategic Development at ProductLife Group, discusses the opportunities – and funding and regulatory challenges – facing small and mid-sized biopharma companies as they deliver innovation to the global market.
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New harmonised guidance for post-approval changes released by FDA
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
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FDA outlines plan for making inspections more consistent going forward
The new report shows over 8,000 planned inspections were postponed due to COVID-19 and outlines the FDA’s plan for a more consistent future state of operations.
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Pakistan approves Zofin™ for compassionate use in COVID-19 patient
Organicell’s Zofin™ therapy has been approved by the Pakistani regulators to be used for a patient with severe COVID-19 on compassionate grounds.
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FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
