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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
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
Senate lawmakers want to give the FDA $2.588 billion in discretionary funds in the next fiscal year, a $36 million boost over current levels and $13 million more than is provided in a related House bill. Read More
Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data. Read More
German drugmaker Sanum-Kehlbeck has been cited for using the same equipment to produce penicillin and non-penicillin products, a situation that could lead to serious allergenic reactions in some patients. Read More
The FDA has approved Japanese drugmaker Takeda Pharmaceutical’s biologic injection Entyvio to treat adults with moderate to severe ulcerative colitis or Crohn’s disease. Read More