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EMA issues opinion on nitrosamines in medicines
The agency’s opinion will require companies to take measures to reduce nitrosamine impurities in medicines and carry out and action the results of risk assessments.
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TXA127 enters multiple Phase II trials in COVID-19 patients
A pharmaceutical formulation of the human angiotensin peptide, TXA127, will enter Phase II trials in hospitalised COVID-19 patients not in intensive care.
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Phase III COVID-19 antibody trials initiated in Americas
Simultaneous Phase III trials evaluating Regeneron’s REGN-COV2 antibody as both a prophylactic and a treatment have begun in US and some South American locations.
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Long-acting injectable HIV PrEP outperforms commercially available daily pill
Extensive analysis of interim data finds patients given cabotegravir injection had a 66 percent lower incidence of HIV acquisition than those taking Truvada pills.
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US trial testing Kevzara® (sarilumab) as a COVID-19 treatment stopped
Companies leading trial announce Kevzara failed to meet primary and secondary endpoints in critically ill COVID-19 patients, so the trial has been halted.
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EMA recommends Idefirix (imlinfidase) is granted marketing authorisation
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
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Common cancer treatments do not worsen COVID-19 infection, study finds
A study has found that chemotherapy and surgery do not correlate with worse COVID-19 outcomes for cancer patients, whereas taking immune checkpoint inhibitors does.
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How implantable systems and microparticle depot injections are meeting the needs of long-acting drug delivery
Implantable systems and microparticle depots are used in many areas of drug delivery to release medicines at a controlled rate within the body. The use of these long-acting dosage forms eliminates the need for frequent administrations via traditional routes of administration, which ensures patient compliance and results in improved outcomes.…
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The impact of supply chain risks and LAL reliance
For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.
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Consortium established to monitor COVID-19 vaccines after marketing
A new consortium has been formed for the study of COVID-19 vaccines after their approval, to monitor their safety and efficacy.
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EMA issues guidance on medicine impurities, in light of nitrosamine detection
After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.
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Novel prostate cancer drug formulation could improve drug’s efficacy
A new oil-based oral formulation of prostate cancer drug abiraterone acetate could enable a smaller dose of the drug to be effective and reduce possible side effects, a study has shown.
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Dexamethasone to be available on NHS as COVID-19 treatment
The UK government has approved dexamethasone to be available on the NHS, following clinical trials proving its efficacy at reducing the risk of death for COVID-19 patients.
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Torbay Pharmaceuticals recalls two batches of Epistatus (midazolam)
Due to a potentially faulty and incorrectly engaged child-resistant container closure, Torbay Pharmaceuticals has announced a recall of certain Epistatus (midazolam) batches.
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MHRA suspends patient recruitment to UK COVID-19 hydroxychloroquine trials
After evidence suggesting hydroxychloroquine has no benefit against COVID-19, the MHRA has suspended further recruitment to clinical trials investigating the drug in the UK.