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Summarising 2019: a year of firsts for the EMA
The EMA was a proactive force in 2019, granting marketing authorisation for a range of drugs. This article highlights some of the most important advancements made by the agency last year.
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Strengthened regulatory systems are needed to improve drug safety, says report
The report reveals practical regulatory reforms that could move the globe closer to the UN’s goal of achieving universal health coverage by 2030.
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Cyber-security breaches at 67 percent of healthcare organisations last year
A survey has found that a large portion of healthcare organisations in the UK experienced cyber-security incidents last year, which were mostly due to employees sharing data.
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FDA issues warning letter to Health Pharma for cGMP violations
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
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FDA issues alert for cancer risk from Belviq (lorcaserin)
The US FDA has announced a warning to healthcare professionals and patients that the weight management drug Belviq may be a cause of cancer.
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UK pharmacist who illegally sold drugs sentenced in court
Jasper Ojela, a registered pharmacist who admitted to supplying the black market with drugs including cancer medications, has been given a 28-month prison sentence.
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Phase III STRENGTH trial for Epanova in mixed dyslipidaemia will close
On recommendations by an independent committee, AstraZeneca will close its STRENGTH trial for Epanova, which has shown low likelihood of being beneficial to patients with mixed dyslipidaemia.
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Endo agrees opioid settlement payment with Oklahoma for $8.75m
The US state of Oklahoma has agreed to a settlement from Endo International after an investigation into its role in the opioid abuse crisis.
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Life science M&A activity reached $357bn in 2019, report finds
According to new research, M&As within the life science industry reached a high last year and is expected to continue its growth in 2020.
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Taro Pharmaceuticals voluntarily recalls one lot of lamotrigine tablets
Due to cross-contamination with enalapril maleate, Taro is voluntarily recalling one lot of its lamotrigine tablets at the consumer level.
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T-cell lymphomas treatment trial update announced by Innate Pharma
Enrolment of new patients in the TELLOMAK trial, which has been evaluating the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas, has been suspended.
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Establishing a new pharmaceutical track and trace system in Dubai
Health authorities in Dubai have announced that they will introduce a new track and trace system to the emirate by mid-2020. This article investigates how this will help to improve the safety and quality of medicinal products.
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NICE argue for more histology-independent cancer drug evidence
Staff at NICE have co-authored a paper which suggests that new, histology-independent cancer treatments require more clinical evidence before approval recommendation by the institution.
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FDA announces one nizatidine and two ranitidine voluntary recalls
Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
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The Advance Value Framework: evaluating the benefits of novel medicines
Researchers have proven their methodology for drug benefit evaluation to be effective as a decision support tool in a study with several European drug evaluation bodies.
