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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
EU member states will be able to purchase pandemic vaccines and other medical countermeasures as a group, under a new procurement scheme adopted last month. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to the European Medicines Agency verifying that the information used to gain marketing authorization remains valid in practice. 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
With generic competition on the horizon, Sanofi and Eli Lilly are collaborating to turn the popular erectile dysfunction drug Cialis into an OTC product. Read More
Janssen Pharmaceuticals’ psoriatic arthritis biologic Stelara is not a cost-effective option for adults who have not responded well to non-biological drugs used to slow down disease progression, say British health-payment authorities. Read More
Drugmakers who redact commercially confidential information from clinical study reports in Europe will have to justify their actions, says a spokesman for the European Medicines Agency, explaining what categories of confidential information the redacted data fall under. Read More
The FDA now has the power to stop any pharmaceutical import it suspects could be adulterated or misbranded, according to a final rule that implements the agency’s new import authority. Read More