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

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

Failing to communicate with a sponsor in a timely manner or collect data from clinical sites may be signs that a CRO isn’t doing its job — and a sign that it’s time for the sponsor to find a new partner, experts say. 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

Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to verify that the information used to gain marketing authorization in the EU remains valid in practice. Read More

Canadian drug regulators have begun publicizing the results of reviews the health ministry conducts into drug safety issues. Read More

Shortly after the EMA announced it would consider redacted clinical trial reports in its proposed transparency plan, AbbVie said it was dropping two lawsuits against the agency. Read More

EU officials continued to show their willingness to meet drugmakers halfway on new plans for publication of clinical trial reports. Read More

The FDA Tuesday placed a clinical hold on Halozyme Therapeutics’ Phase II study of PEGPH20 for the treatment of pancreatic cancer. Read More

The European Medicines Agency is planning a series of May meetings with industry to unveil the process it plans to use to determine whether clinical trial data is considered confidential under its new transparency rules or whether it must be disclosed. Read More

Drugmakers and non-profit collaborators are releasing the results of failed cancer trials so that researchers can examine the datasets to look for signals or other useful information that may suggest new research directions. Read More

AbbVie has dropped two lawsuits against the EMA over the agency’s plans to disclose clinical trial data for its rheumatoid arthritis drug Humira (adalimumab), clearing a major hurdle for the EMA’s transparency initiative. Read More