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House lawmakers are seeking new ways to streamline the drug development and approval process, calling for solutions to reverse high costs of clinical trials and the slow supplemental application pathway. Read More
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and excipient — at contact sites of the body as part of a clinical trial’s general toxicity studies, according to new draft guidance.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
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
The FDA plans to release a document later this year that will explain how devicemakers can use the agency’s benefit-risk framework for device approval when designing different types of clinical trials, CDRH Director Jeffrey Shuren said Wednesday. 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
The UK’s Health Research Authority is helping drugmakers do a better job justifying their trial designs and protocol assumptions early on to avoid trial failures due to insufficient information. Read More
The FDA is creating tough new standards for clinical trials that use live case presentations, requiring that devicemakers discuss all potential risks and benefits in their investigational plans. Read More
A UK coalition of drugmakers and a cancer research group are launching an analysis of failed Phase III lung cancer drug trials that will search for treatments that, despite failing overall, are effective for certain subpopulations. Read More
Baxter said Wednesday that its Bax 111 treatment for Von Willebrand disease met its primary endpoint in a pivotal clinical trial, setting it up for NDA filing later this year. Read More
The European Parliament advanced major data privacy legislation in March, but not before amending two provisions that industry had said would cripple clinical research. Read More
Drugmakers should include information for all uses of a product — including off-label uses — when preparing periodic benefit-risk evaluation reports, the International Council on Harmonisation says in new Q&A guidance. Read More