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FDA announces US recall of mirtazapine tablets due to mislabelled strength
Aurobindo Pharma USA, Inc. has issued a voluntary nationwide recall of certain mirtazapine tablets as bottles labelled as 7.5mg may contain 15mg tablets.
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Intravenous delivery of TB vaccine found to dramatically improve potency in models
New research has shown that intravenous injection of the BCG vaccine dramatically reduces monkey susceptibility to TB bacteria and lung inflammation.
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Formulation confidence with recombinant albumin: the benefits of a versatile stabiliser for challenging formulations
The path to formulation of pharmaceuticals is not always straightforward, especially as products are becoming increasingly complex. Recognising strategies with the greatest advantages and considering all the options available to get the best drugs to market can greatly facilitate drug development and formulation. This article will demonstrate how recombinant albumin…
whitepaper
Application note: Non-targeted host cell protein monitoring in downstream process samples using micro Pillar Array Columns combined with mass spectrometry (μPACTM-MS)
This whitepaper reports on the use of μPAC™ in combination with MS for the characterisation of HCPs and their monitoring during downstream processing.
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Roche purchase of Spark Therapeutics is given the go ahead in UK
The CMA has cleared the anticipated purchase of gene therapy company Spark Therapeutics by pharmaceutical company Roche Holdings.
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FDA grants accelerated approval for treatment of rare DMD mutation
The FDA has granted accelerated approval to Vyondys 53 for the treatment of patients with Duchenne muscular dystrophy containing a mutation of the dystrophin gene that is amenable to exon 53 skipping.
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Psilocybin study shows positive results in healthy volunteers
In a new study, COMP360 (psilocybin) was well tolerated in healthy volunteers which support further investigation of a simultaneous 1:1 therapeutic administration design.
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EC approves expanded indication for cystic fibrosis treatment
The European Commission has approved the label extension for KALYDECO® (ivacaftor) to include the treatment of infants with cystic fibrosis between six and 12 months old.
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Multiple sclerosis drug market predicted to reach $32.9bn by 2028
Driven by the launch of various pipeline agents, a new report has projected that the multiple sclerosis therapeutics market will reach $32.9 billion in 2028.
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NICE approves new tablet formulation for olaparib drug
The UK NICE has extended its approval for olaparib, updating its formulation from eight capsules twice a day to two tablets twice daily.
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Strategies developed for improving drug delivery for brain tumour treatment
Scientists have proposed combining ultrasound with other techniques to improve drug transport into brain tumours.
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Priority Review granted to pemigatinib for treatment of cholangiocarcinoma
The US FDA has awarded pemigatinib Priority Review, after the drug met its primary and secondary endpoints in a Phase II trial.
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Beyond nutrition: vitamins and n-3 polyunsaturated fatty acids as APIs
Active pharmaceutical ingredients (APIs) are important compounds used in the manufacture of pharmaceutical drug products. Eric Ciappio discusses the potential of vitamins and n-3 polyunsaturated fatty acids (PUFAs) as APIs, with a focus on their clinical relevance.
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New methodology allows for deeper understanding of how drugs interact
A methodology has been developed which characterises how drugs influence each other when combined during treatment and sheds new light on how drugs perturb the underlying molecular networks.
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Quality control solutions that fuel confident decisions
As the partner of choice for managing microbial quality control, Charles River’s products and services facilitate confident and objective decision-making, ensuring the integrity of your microbial data, reducing risk, building efficiency and improving your bottom line, while assisting in the journey to bring products to market.
