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NICE fails to recommend pembrolizumab in final draft guidance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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iPDF: Complete solution for your sterility testing workflow
Extensive portfolio of quality control solutions. Full regulatory compliance (USP, EP, JP Pharmacopoeias) of your sterility testing workflow.
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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.
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FDA approves Isturisa (osilodrostat) treatment for Cushing’s disease
The FDA has approved Isturisa for Cushing’s disease treatment after it demonstrated significant efficacy in clinical trials.
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3.5 million unlicensed erection pills seized in the UK in 2019
The UK MHRA has announced that the approximately 3.5 million unlicensed erection pills seized last year are worth more than £10 million.
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FDA approves DURYSTA™ (bimatoprost implant) New Drug Application
The DURYSTA ocular implant has been approved by the FDA to reduce intraocular pressure in open-angle glaucoma or ocular hypertension.
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Emerade 150 micrograms auto-injectors recalled in UK
The UK MHRA has announced that Emerade 150 micrograms solution for injection is being recalled due to an error in one component of the auto-injector.
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Online pharmacy finds high levels of NDMA in metformin
Tests conducted by an online pharmacy has revealed high levels of NMDA in the diabetes drug metformin, prompting the company to press for a recall.
