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Shortage of Accord’s phenytoin sodium expected until May
The UK DHSC has issued an alert that phenytoin sodium 100mg capsules made by Accord will be out of stock until May.
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Gilteritinib not recommended by NICE for AML treatment
NICE has said it will not recommend gilteritinib for treatment of acute myeloid leukaemia (AML) due to uncertainty around long-term survival expectancy and its cost-effectiveness.
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GSK halts Excedrin production due to manufacturing inconsistencies
GlaxoSmithKline has announced that it will not be manufacturing or distributing some of its Excedrin products after inconsistencies in ingredient transfer and weight.
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The biggest pharmaceutical industry M&A deals of 2019
The pharmaceutical industry saw some notable mergers and acquisitions in 2019; this article lists the top 10 by transaction size.
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FDA announces drug product recall due to lack of sterility assurance
FUSION IV Pharmaceuticals, Inc dba AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products to the user level as they do not adhere to federal guidelines.
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‘Super-human’ red blood cells could revolutionise drug delivery
Modified ‘super-human’ red blood cells containing therapeutic compounds have been developed by researchers as a novel form of drug delivery.
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PQE GROUP, the international quality solution provider, at Interphex to consolidate its presence in US
PQE Group, the consulting company in the pharmaceutical field, based in Italy, has chosen “Interphex” to strengthen its presence on the US market.
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Edible security tag for drugs developed to combat counterfeits
Researchers have created a unique edible film to be added onto the surface of drugs which can produce a security key, preventing counterfeits from reaching patients.
article
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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Fast Track Designation granted to decompensated heart failure treatment
The US FDA has granted Fast Track Designation to APD418, which is in development as treatment for decompensated heart failure patients.
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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.