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Highlighting a growing dispute in the pharmaceutical industry, Johnson & Johnson is arguing that biosimilars should have international non-proprietary names (INN) that are similar to, but distinguishable from, reference products. Read More
Novartis’ valsartan woes escalated Thursday as Japan followed the U.S. in filing a legal complaint against the Swiss drugmaker over its marketing practices for the blood pressure drug. Read More
Drugmakers should evaluate a product’s UV-visible absorption spectrum before starting clinical development, the ICH says in a new guideline that will standardize photosafety testing standards across the EU, Japan and U.S. Read More
The European Medicines Agency is encouraging drugmakers looking to apply novel drug development tools to seek the EMA’s blessing first and get qualification or prospective advice. Read More
Less than a month after AstraZeneca said it was buying out Bristol-Myers Squibb’s part of its diabetes pipeline partnership, the FDA Wednesday approved their type 2 diabetes drug Farxiga. Read More
The Clinical Data Interchange Standard Consortium (CDISC) is asking for input on a new data submission standard that could give clinical trial sponsors and reviewers greater flexibility if adopted by the FDA for drug review applications. Read More
FDA Commissioner Margaret Hamburg has named Howard Sklamberg as the agency’s new deputy commissioner of global regulatory operations and policy. Read More
The Centers for Medicare & Medicaid Services (CMS) plans to force makers of antidepressants and immunosuppressants to compete for inclusion on Medicare Part D formularies, which it hopes will compel drugmakers to lower prices. Read More
The drug industry wants the FDA to drop plans to require drugmakers to report manufacturing stoppages that will result in shortages within five days of the stoppage occurring. If any timeline is imposed, 15 days is adequate, industry says. Read More
The FDA is encouraging drugmakers to work together to get agency qualification for drug development tools (DDTs), which can then be used to aid in development and review of multiple companies’ drugs. Read More