Draft guidance on CDER’s program to recognise standards in pharmaceutical quality
Draft guidance has been released to offer advice on the new CDER program for the recognition of voluntary consensus standards relating to pharma quality...
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Programs to promote innovations in drug manufacturing
Innovations in drug manufacturing could result in higher quality drugs at less of the cost, and the FDA is willing to help facilitate this development...
SMC accepts restricted use of rivaroxaban for CAD
The SMC has approved a drug, called rivaroxaban, that targets Factor Xa to treat those with coronary artery disease (CAD)...
Phase III clinical trial for treatment of dry eye syndrome
A Phase III trial looks to treat dry eye syndrome using a sterile, preservative-free eye drop formulation that has thymosin beta 4 as its active ingredient...
Health Canada issues NOC/c for oral myeloid leukaemia therapy
Health Canada has issued a Notice of Compliance with conditions for the first oral drug for acute myeloid leukaemia, a rapidly progressing condition...
Following FMD rulings using a ‘pragmatic’ approach
The falsified medicines directive (FMD) has finally kicked in, but how will the UK supply chain be affected, and how will pharmacies and hospitals cope?
Method for improving infrared imaging performance
Researchers have identified a method of improving the performance of infrared imaging techniques which could be useful in medical applications...
NICE and Canadian Agency collaborate to offer parallel scientific advice
NICE in the UK and its counterpart - the Canadian Agency for Drugs and Technology in Health have collaborated to offer parallel scientific advice...
FDA launches pilot programme to track and trace US supply chain
The pilot project will test innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the US...
Compressed injection pill for oral insulin delivery
A compressed injection pill could be the future alternative to injections of insulin delivery for patients with type 2 diabetes...
Pharmapack Europe award winners 2019 – 22 years of innovation
Innovations across drug delivery devices, dosage packaging, and materials and components bestowed in the Exhibitor Innovation Category...
Microbiological considerations in cleanroom validation
Wickham Laboratories Ltd is delighted to announce our most recent technical article on, “microbiological considerations in cleanroom validation”, which has been featured in European Pharmaceutical Review’s December 2018 issue...
Omadacycline similar to commonly-used antibiotics for treating pneumonia, skin infections
Findings of two phase III, double-blind, randomised clinical trials comparing omadacycline with standard antibiotics have been published in the New England Journal of Medicine
Combination antiplatelet therapy reduces risk of recurrent stroke
A combination therapy using the blood thinner cilostazol, along with either aspirin or clopidogrel, was shown to decrease the risk of stroke recurrence...
FDA approval for Cablivi to treat rare clotting disorder
The FDA has approved the first specific therapy for the rare blood clotting disorder, acquired thrombotic thrombocytopenic purpura (aTTP)...
