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EU regulators are urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic (PD) profiles as the gold standard in proving efficacy similarity to the reference products. Read More
The European Medicines Agency (EMA) is recommending clinical trial sponsors evaluate local tolerance of medicinal products — i.e., both the active substance and excipient — at contact sites of the body as part of a clinical trial’s general toxicity studies, according to new draft guidance. Read More
Manufacturers should include effective evaluation and verification studies in their process validation documentation when obtaining biotechnology-derived proteins in the EU, according to a new guidance from the European Medicines Agency (EMA). Read More
The European Medicines Agency (EMA) is considering new trial designs using pathologic complete response (pCR) as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early stage breast cancer. Read More
OncoGenex Pharmaceuticals Wednesday said the FDA has granted fast-track designation for the drugmaker’s investigational drug custirsen as a second line treatment for men with metastatic castrate-resistant prostate cancer (CRPC) and non-small cell lung cancer. Read More