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MHRA issues FMD over HMS Wholesale Limited products
A Class 4 falsified medicines directive (FMD) has been issued by the MHRA because medicines may have left the legal supply chain to be reintroduced later through HMS Wholesale Limited.
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Anti-malarial drugs donated to aid fight against COVID-19
The producers of hydroxychloroquine have stated they will donate 130 million doses if the drug is approved as a treatment for the COVID-19 coronavirus.
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Novartis recalls Sandimmune and Neoral over risk of poisoning
The company is recalling 100mg blister packages of both Sandimmune and Neoral due to their packaging not being child-resistant, a fault that could result in infants being poisoned.
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Researchers to trial SNG001 therapeutic in COVID-19 patients
Hospitalised patients in the UK will inhale the interferon beta 1a (IFN-β) formulation or a placebo to see if SNG001 is effective against the COVID-19 coronavirus.
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MEDICRIME – tackling falsified medicines in Europe
In 2014, medicines were stolen from Italian hospitals and resold across Europe. The authors of a new report highlight the flaws in regulations that handed the perpetrators insufficient sanctions and explain why MEDICRIME provides a better regulatory framework.
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Global operation identifies 34,000 falsifed coronavirus medicines
Operation Pangea has revealed a large number of falsified coronavirus treatments, while the MHRA has seized 871,616 doses of other unlicensed medicines.
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Licence of Esmya (ulipristal acetate) suspended
Esmya (ulipristal acetate)'s licence has been suspended due to the risk of serious liver injury, says the UK government.
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EMA issues statement on ibuprofen reports relating to COVID-19
The EMA has announced that reports of NSAIDs like ibuprofen making the COVID-19 coronavirus worse have no scientific basis.
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“Harmonised approach” promoted for COVID-19 treatment clinical trials
The EMA has urged that the research community prioritise large randomised controlled studies for COVID-19 treatments and vaccines.
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Increasing awareness will augment the pharmacovigilance market
A growing requirement for drugs to be safe and effective is being driven by public awareness and understanding. Nilesh Londhe discusses why this pharmacovigilance is increasing.
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FDA approves label update to sodium glucose co-transporter-2 (SGLT2) inhibitors
Safety updates to labels of SGLT2 inhibitors will recommend temporary discontinuation of these medications before scheduled surgery, says the FDA.
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Handheld Raman spectrometer developed to analyse THC levels in cannabis plants
Researchers have modified a portable Raman spectrometer that can determine the level of THC in cannabis plants, which they say could be used by farmers wishing to grow hemp.
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Concizumab haemophilia trials paused over safety concerns
The occurrence of non-fatal thrombotic events in Phase III study participants has called into question the safety of concizumab.
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Olumiant (baricitinib) granted Breakthrough Therapy designation by FDA
Baricitinib has been granted Breakthrough Therapy as a treatment for alopecia areata, an autoimmune condition with no FDA-approved therapies.
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EMA begins safety review of ifosfamide cancer medicines
The EMA has announced the results of its pharmacovigilance meeting for March, saying that it has started a review of medicines containing ifosfamide due to a higher risk of encephalopathy.
