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“Harmonised approach” promoted for COVID-19 treatment clinical trials
The EMA has urged that the research community prioritise large randomised controlled studies for COVID-19 treatments and vaccines.
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Increasing awareness will augment the pharmacovigilance market
A growing requirement for drugs to be safe and effective is being driven by public awareness and understanding. Nilesh Londhe discusses why this pharmacovigilance is increasing.
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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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Clinical programme to evaluate Kevzara® as COVID-19 treatment begins
Led by Sanofi and Regeneron, clinical trials to examine Kevzara (sarilumab) as an effective COVID-19 treatment will begin in the US.
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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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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NICE fails to recommend pembrolizumab in final draft guidance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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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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Ofev® (nintedanib) approved by FDA to treat interstitial lung diseases
The FDA has granted marketing authorisation for Ofev, as the first treatment for patients with chronic fibrosing interstitial lung diseases (ILDs).
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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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Re-shaping pharmaceutical transport: global air cargo trends
As environmental consciousness increases, the future of pharmaceutical transport looks uncertain. Dominic Hyde discusses the impacts of these developments on air cargo and freight.
