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The European Medicines Agency is considering new trial designs using pathologic complete response, or pCR, as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early-stage breast cancer. Read More
The European Medicines Agency is urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic profiles as the gold standard in proving efficacy similarity to their reference products. Read More
The European Medicines Agency is recommending that clinical trial sponsors evaluate local tolerance of medicinal products at contact sites on the body as part of a trial’s general toxicity studies. Read More
Drugmakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s drug laws are adopted. Read More
Novartis wants the FDA to back off plans that would require drugmakers to include details of clinical trials data in labeling for drugs brought to market under accelerated approval pathways. Read More
Institutional review boards (IRBs) that assume oversight of a clinical trial from another IRB should give drugmakers an opportunity to address any concerns the receiving IRB has with the study before it is terminated or suspended, the FDA says in a final guidance that makes only minor tweaks to the 2012 draft. Read More
The Therapeutic Goods Administration is updating its guidance on the collection, maintenance and disclosure of commercially confident information, focusing on eight principles agency staff should consider in disclosing submitted information. Read More
Devicemakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s 1945 Drug and Cosmetic Rules are adopted. Read More
GlaxoSmithKline’s efforts to expand the indication for its cancer drug Arzerra were dashed when the drug failed to meet its primary endpoint in a Phase III trial. Read More
Devicemakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s 1945 Drug and Cosmetic Rules are adopted. Read More
Manufacturers looking to speed up drug approvals in Europe, and ensure their products will be covered by payers, should initiate early parallel conversations with both the European Medicines Agency and the Health Technology Assessment Bodies (HTABs), the EMA says. Read More
The European Medicines Agency is considering new trial designs using pathologic complete response, or pCR, as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early-stage breast cancer. Read More