Real-world data and its endless potential
The possibilities presented by real-world data to improve drug development processes could enhance regulatory and pricing decisions for new therapeutics.
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The possibilities presented by real-world data to improve drug development processes could enhance regulatory and pricing decisions for new therapeutics.
The Kymriah (tisagenlecleucel) treatment has received a positive appraisal from the Scottish Medicines Consortium, after EMA approval last year.
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
The Chinese pharmaceutical industry has been lagging behind in terms of drug development and bringing new products to the market. In this article, Megha Baruah discusses the changes the National Medical Products Administration (NMPA) of China is making to existing policies and informs on guidance documents that have been released…
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Faïs discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
The licence extension submission for Invokana and Vokanamet has been accepted by the EMA.
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
The FDA has given its approval to RINVOQ for the treatment of active rheumatoid arthritis after the drug reached its endpoints in clinical trials.
The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström's macroglobulinemia.
The EMA has requested that liposomal medication names be changed to avoid the risk of confusion.
EMA’s human medicines committee had cleared the cannabidiol oral solution, Epidiolex, for use to treat seizures.
The EMA has announced its approval for marketing authorisation in the EU for Vitrakvi (larotrectinib), used to treat solid tumours with a specific gene mutation.
Orphan Drug Designation has been given to AR-501 for the treatment of lung infection in patients with cystic fibrosis.
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
The EU has issued two guidance documents intended to advise the pharmaceutical industry and patients during medicinal shortages.