FDA recommends LC-HRMS to test for NDMA in ranitidine products
The FDA recommends drug manufacturers to use LC-HRMS to test for NDMA in ranitidine products, as high temperatures generate the impurity.
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UK government introduces trade restrictions to reduce drug shortages
The government has announced new measures to prevent parallel exporting to ease the supply chain, in an effort to reduce medicine shortages.
FDA and DEA send joint warning letters to illegal opioid sites
The FDA and DEA have, for the first time, sent joint warning letters to four networks which were illegally selling opioid products.
Making Science Work at CPhI Worldwide 2019
CPhI Worldwide now comprises six individual pharma events and more than 20 dedicated zones.
AstraZeneca receives FDA complete response letter for PT010
The FDA has given a complete response letter to AstraZeneca for its PT010 treatment, regarding its New Drug Application.
J&J reach $20.4m settlement agreement over opioid trial
Johnson & Johnson have reached a settlement with two Ohio counties over its role in the opioid crisis, removing the company from the trial due to begin later this month.
Survey finds shortages in all medicine categories in UK pharmacies
A survey of pharmacists has discovered that UK pharmacies experienced shortages across all 36 medicine categories in the last six months.
Drugmakers may use Purdue’s bankruptcy to settle opioid suits
Drugmakers that face litigation over the opioid crisis are looking at ways to settle the cases by using Purdue's bankruptcy, it has been reported.
Mergers & Acquisition activity within the pharmaceutical industry ‘remains high’, report finds
Large-value deals are a new strategy for stakeholders to capitalise on the strengths of other companies and to overcome barriers to financial success.
Lipid nanoparticles used to deliver RNA in vaccines
Researchers have developed a series of lipid nanoparticles, which encapsulate RNA, for effective and improved vaccine delivery.
First treatment for children with rare vasculitis diseases approved
Rituxan (rituximab) is the first approved treatment for children with rare vasculitis diseases, in which a patient’s small blood vessels become inflamed.
UK audit body finds no-deal Brexit drug supply preparation lacking
The UK National Audit Office has released a report which has found that medicine supply to the UK will be delayed in the event of a no-deal Brexit.
Boost needed for innovation in Indian pharma, study finds
Research has found that the pharmaceutical industry in India must encourage innovation in order to keep up with the growth of the sector.
EMA releases guidance to companies on avoiding nitrosamines in drugs
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
Daratumumab approved for multiple myeloma treatment
The drug daratumumab has been approved for treatment of multiple myeloma, demonstrating increased efficacy when used in combination with other drugs.
