news
Forxiga approved in EU for chronic kidney disease treatment
Forxiga’s approval, based on unprecedented Phase III data, is the most significant advancement in chronic kidney disease (CKD) treatment in over 20 years.
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Regulation & Legislation
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, August 2021
The EMA's drug safety committee (PRAC) recommends updating risks of Janssen COVID-19 Vaccine, though the benefit-risk balance remains unchanged.
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On-demand webinar: The art of changing QC testing methods
Learn how you can go about changing QC test methods and how this can go a long way to helping your lab achieve data integrity compliance.
news
AstraZeneca reveals $15.54 billion in revenues in H1 2021
H1 financial results show AstraZeneca’s revenues grew by 23 percent in 2021, with $14.37 billion attributed to activities aside from COVID-19 vaccine sales.
news
NICE approves cost-comparison fast-track appraisal pilot
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
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FDA approves emergency use of REGEN-COVTM for COVID-19 prevention
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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Biden Administration to support resilience of US pharma supply chain
US President announces $60 million in funding to support domestic API production and a consortium to onshore essential medicine manufacturing.
whitepaper
Case study: RMM to reduce plate counts
See how a pharma company maintained product quality and reduced risk by using an RMM analyser, while also meeting their goal of reducing plate counts by 25 percent.
news
FDA approves first interchangeable biosimilar insulin product
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.
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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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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.
news
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.
news
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.
news
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.
whitepaper
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.
