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Medicine regulators should increase collaboration, says new report
The US National Academies of Sciences, Engineering, and Medicine have released a report that suggests regulators need to collaborate more to ensure drug quality.
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EC approves two new regimens of Keytruda for HNSCC
The European Commission has given its approval to Keytruda to treat head and neck squamous cell carcinoma as a monotherapy or in combination with a chemotherapy.
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Application note: Determining the structure of impurities
Most, if not all pharmaceutical companies will have experienced a product, that has been on the market for a long time, to suddenly and unexpectedly trigger a signal for an unknown substance in the quality control (QC) laboratory approval process.
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Precision Dose voluntarily recalls ranitidine oral solution
The FDA has announced that Precision Dose Inc is voluntarily recalling five lots of its ranitidine oral solution in the US.
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Medicine delivery by drone – implications for safety and quality
Drones that transport medicines to emergency situations, urban environments or geographically-challenging locations are increasingly being utilised to improve delivery, however, there are few studies on their impact on drug stability. Here, Paul Royall and Patrick Courtney explore the implications of drone delivery on the safety and quality of medicines.
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Tc-99m radiopharmaceuticals and in-house chromatographic methods
Technetium-99m (99mTc) is a synthetic radioisotope that is used worldwide to produce radiopharmaceuticals that are mainly used for diagnostic purposes in nuclear medicines. The purity of the final radiopharmaceutical (99mTc-R) can be confirmed by applying chromatographic methods. This method is based on different rates of movement of substances in a…
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Analytical method transfer and the supplier change processes for bacterial endotoxin testing
Changes to lab setups become necessary for many reasons, but the important role of quality control should remain consistently accurate. Tim Sandle and Kerry Skinner describe the details to consider when transferring an analytical method between laboratories or when changing your reagent supplier.
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Keytruda overtakes Opdivo in Q3 sales to reach $3.1bn
Sales of Merck’s drug Keytruda have grown beyond those of Bristol-Myers Squibb’s Opdivo, to become the global leading PD-1 inhibitor.
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Medical cannabis: face-to-face with Dr Amir Englund
Dr Englund discusses his research into medical cannabis, highlighting a range of its potential uses. He also explores some of the challenges that can be faced in clinical trials when investigating cannabinoids.
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Leaked document reveals ‘unprecedented’ medicine shortages in NHS
A document from the DHSC has reportedly advised NHS doctors to ration certain medicines after outlining dozens of drugs that are in shortage, as published in a report.
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Pernicious microorganisms: risks of contamination in pharma
Some pharmaceutical manufacturers can struggle to keep microorganisms away from their facilities, which sometimes goes unnoticed until it is too late. While there are numerous threatening microorganisms, this article focuses on some of the most troublesome, highlighting the hazards they pose and analysing how manufacturers can prevent microbial contamination in…
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EMA announces medicine approval recommendations from November meeting
The EMA CHMP has revealed its suggestion to grant marketing authorisation to seven medicines after its most recent meeting.
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ABPI release medicine manifesto for new UK government after election
The ABPI’s Manifesto for Medicine has been issued, calling upon the next government in the UK to work closely with the pharma industry to increase innovation and access to medicines.
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Guide to Data Integrity
In this guide to data integrity, OSIsoft showcase their services and highlight how they stand out from the crowd.
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Aurobindo recalls prescription and over-the-counter ranitidine
Aurobindo has recalled prescription and over-the-counter ranitidine due to the medications containing unacceptable levels of NDMA.
