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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.
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NICE fails to recommend pembrolizumab in final draft guidance
The UK NICE has not found pembrolizumab cost-effective for use on the NHS, after a review of evidence collected while the drug was available via the Cancer Drugs Fund.
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NICE recommends fremanezumab for chronic migraine prevention
The UK’s National Institute for Health and Care Excellence, NICE, recommends the use of fremanezumab on the NHS for preventing chronic migraine.
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EC grants Orphan Drug Designation to FLT190, a Fabry Disease treatment
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
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Limiting antibiotic manufacturing discharge in Indian wastewater
During the manufacture of antibiotics, residues can contaminate the environment through wastewater, leading to antimicrobial resistance. However, a new government initiative in India aims to prevent this by regulating effluent.
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MHRA issues Medicine Defect Information about Aripiprazole
The regulatory body has issued guidance based on a complaint that stated a precipitate formed in Aripiprazole 1mg/ml oral solution.
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Hikma Pharmaceuticals extends Ketorolac Tromethamine recall in US
The FDA has announced that Hikma are now recalling certain lots of Ketorolac Tromethamine injections at the medical facility and retail levels.
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New HIV PrEP drug could derail efforts to expand virus prevention coverage
US researchers have stated a newly approved HIV pre-exposure prophylaxis (PrEP) therapy does not have benefits that warrant its price tag and could deter generic competition.
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FDA and FTC issue warning letters to companies selling fraudulent COVID-19 products
The US agencies have issued letters to seven companies, and removed online listings from others, whose products falsely claim to prevent or treat coronavirus.
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Exploring data integrity guideline changes moving into 2020
European Pharmaceutical Review explores how a surge in the number of warning letters for data integrity failings have prompted regulators to publish new guidelines.
