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Over £100mn in fines for pharma firms hiking prices of crucial thyroid drug
The Competition and Markets Authority fines Advanz and two others for hiking prices of liothyronine tablets by 1,110 percent in eight years.
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Regs & Legs
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What lies ahead in the regulatory pipeline for medical device manufacturers? A compliance strategy to meet the 2023 Class II deadline
Here, Kallik’s Bob Tilling discusses the importance of acting early and embracing technology to comply with EU MDR labelling requirements, citing challenges from the recent scramble by many Class III medical device manufacturers to meet their May 2021 deadline.
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British generics manufacturers call for Northern Ireland supply to be sorted
Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA), urges EU and UK to put patients above politics in solving medicine supply challenges for Northern Ireland.
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Regulators call for clinical research to include pregnant and breastfeeding women
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
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EMA recommends approving Spikevax COVID-19 vaccine for adolescents
Based on new clinical results, the EMA is recommending Moderna’s Spikevax COVID-19 vaccine be approved for use in children aged 12 to 17 years.
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J&J to pay up to $5bn in US opioid settlement
Johnson & Johnson has signed a nationwide opioid settlement agreement and will pay billions to settle opioid-related claims and litigation in the US.
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Case study: RMM for identifying contamination sources
See how a leading biopharma company used an RMM analyser in parallel to plate counts to find the root cause of periodic bioburden excursions in its water system.
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EMA’s human medicine committee (CHMP) meeting highlights, July 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
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Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
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Case study: 7000RMS & process control strategy
Learn how Mibelle Group improved their process control strategies using the 7000RMS analyser in parallel with validated plate counts.
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Whitepaper: Cleaning validation
This whitepaper discusses cleaning validation and the considerations required for a successful outcome.
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Whitepaper: Learn about biofilm in hot WFI
This paper explores the presence of biofilm in hot WFI systems and the use of rapid microbial methods to overcome the limitations of plate counts.
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Revised general chapter on chemometric methods available for comment
The revised general chapter 5.21 has been published in Pharmeuropa 33.3, the European Pharmacopoeia online forum, for public comment.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
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FDA suggests principles for implementing bio-fluorescent particle counters
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
