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Medicinal cannabis product granted approval in Ireland
A medicinal CBD oil has been approved for importation, prescription and supply under the Medical Cannabis Access Programme (MCAP) in Ireland.
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FDA updates guidance for adaptive clinical trial reporting
The US Food and Drug Administration has announced new guidance for drug applications that include results from adaptive clinical trials.
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Dr Richard Torbett named as new ABPI Chief Executive
The ABPI’s board has unanimously appointed Dr Richard Torbett as Chief Executive, commencing 1 January 2020.
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The Brexit test: protecting pharmaceutical quality standards through better analysis
In the wake of Brexit, the pharma industry will need to respond to a new regulatory landscape. Peter Morgan discusses how businesses have to prepare for the oncoming political changes, all whist retaining high pharmaceutical product quality.
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Campaign calls for more effort to combat counterfeit medicines
A week-long awareness-raising campaign has been launched to combat the spread of substandard and falsified medicines.
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Drug prices in China cut by up to 61 percent for reimbursement scheme list
Top pharmaceutical companies have reduced their drug costs in China by an average of 61 percent, to be added to the reimbursement list in the country.
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Generics and biosimilars vital to reduce healthcare costs, finds EC
The EC has released a report that has found generics and biosimilars decrease wasteful spending and maintain health quality in the EU.
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Combatting drug shortages in the EU: new guidance
New guidance for marketing authorisation holders has been released by the EMA to reduce the impact of drug shortages in the EU. Maurits Lugard and Anna-Shari Melin at Sidley Austin discuss the document and highlight its main points.
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FDA issues warning letter for marketing unapproved products
A warning letter has been issued by the FDA for products illegally marketed for the treatment of health conditions, including opioid withdrawal symptoms.
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Avacopan Phase III trial meets primary endpoints
A study to demonstrate the safety and efficacy of avacopan has produced topline results, according to the pharmaceutical company developing the drug.
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Research Report: Industrial Transformation Challenging in Life Sciences
Industrial transformation is a very real phenomenon. Companies are going beyond standard practices to seek out step-change improvement in industrial operations, with several companies already reporting "dramatic results".
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IoT could transform the pharma industry through these steps
Adopting IoT systems as a pharmaceutical company can provide many opportunities but achieving success can be difficult. James Steiner explains how to effectively integrate IoT solutions into pharma.
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Novartis announces $9.7bn acquisition of The Medicines Company
The M&A between Novartis and The Medicines Company will add inclisiran, the potentially first-in-class treatment to reduce cholesterol, to the former’s pipeline.
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MHRA announces recall of 13 over-the-counter ranitidine medicines
Four companies are recalling batches of certain over-the-counter ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.
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Anti-epileptic drug XCOPRI® approved by the FDA
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.
