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FDA approves Tepezza for the treatment of thyroid eye in adults
The US FDA approved Tepezza (teprotumumab-trbw), the first treatment for thyroid eye, on the basis of two trials in which the drug improved eye protrusion in patients.
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Tiofarma admits role in illegal agreement causing fludrocortisone price hikes
The CMA has announced Tiofarma admits taking part in an anti-competitive agreement with Amilco and Aspen which resulted in huge price increase in fludrocortisone acetate tablets.
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Effectiveness of HPV vaccines Cervarix and Gardasil under question
Analysis of the designs of Phase II and III efficacy trials for HPV vaccines suggest they overstated their effectiveness against cervical cancer, according to researchers.
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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 pharma merger and acquisition 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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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.
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Video: ENDONEXT™ The evolution of endotoxin testing
With Recombinant Factor C (rFC), we’re making Endotoxin testing faster, easier and more ecologically friendly by mimicking nature, not exploiting it.
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Professor Trevor Jones appointed chairman of the European Medicinal Cannabis Association
Professor Trevor Jones, CBE, FMedSci is the new chairman of EMCA, a body that seeks to advocate for evidence-based policy and improving supply and manufacture of quality medicinal cannabis.
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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.
