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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.
In this article, Dr Harsh Shah and colleagues summarise their research into the importance of characterising physicochemical characteristics that can result in stress-induced solid-state changes in Narrow Therapeutic Index (NTI) drugs.
EPR’s Hannah Balfour discusses the findings of market research reports, unveiling how, where and why the global clinical trial packaging market will grow between now and 2027.
![Jazz Pharmaceuticals Sign with Logo [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Jazz-pharmaceuticals-300x278.jpg)
![Jazz Pharmaceuticals Sign with Logo [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Jazz-pharmaceuticals-e1612534960797.jpg)
According to Jazz Pharmaceuticals, the combined company will be a leader in neuroscience, well positioned to maximise the value of its diversified portfolio.
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
Cenobamate’s application was based on a global clinical trials programme enrolling over 1,900 adults with uncontrolled focal-onset seizures.
New research has found that of the drugs in the pre-registration phase, 10 are expected to become blockbusters over the next six years.
Taro Pharmaceuticals is recalling two lots of Phenytoin Oral Suspension USP due to concerns about failure to re-suspend resulting in under or overdosing.
The UK DHSC has issued an alert that phenytoin sodium 100mg capsules made by Accord will be out of stock until May.
Due to cross-contamination with enalapril maleate, Taro is voluntarily recalling one lot of its lamotrigine tablets at the consumer level.
Epidyolex, which contains cannabidiol, can now be prescribed by doctors to epilepsy patients in the UK through the NHS.
A medicinal CBD oil has been approved for importation, prescription and supply under the Medical Cannabis Access Programme (MCAP) in Ireland.
Based on results from two global randomised studies and a large open-label safety study, XCOPRI has been approved by the FDA as a treatment for partial-onset seizures in adults.
A document from the DHSC has reportedly advised NHS doctors to ration certain medicines after outlining dozens of drugs that are in shortage, as published in a report.
NICE and GW Pharma will work together to address the issues highlighted in its evaluation of cannabidiol for treating two types of epilepsy.
