With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues. For now, sponsors should apply the approaches and flexibilities used during the COVID-19 pandemic to the current situation, the groups said March 30.
Executives of Spero Therapeutics Inc. evaded analysts’ attempts to clarify “deficiencies” noted by the U.S. FDA in its ongoing review of the company’s NDA seeking approval of oral carbapenem antibiotic tebipenem HBr for complicated urinary tract infections (cUTIs), emphasizing instead that they have three months to work with the regulator ahead of a June 27 PDUFA date assigned to the application.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CTL Amedica, Radiaction.
The U.S. Preventive Services Task Force (USPSTF) has decided to consider the merits of screening for obstructive sleep apnea (OSA), a condition thought to contribute significantly to the onset of heart disease. Even though five years have passed since the task force considered the merits of screening for asymptomatic patients, USPSTF indicated that there is still insufficient evidence to support the proposition, citing an evidence gap that if filled could prove tremendously useful to makers of devices that diagnose and treat the condition.
Publicly traded companies in the life sciences face a number of sources of litigation, including lawsuits over alleged securities fraud, and a new report by Dechert LLP highlights a diminishing number of such lawsuits across the U.S. economy. However, the proportion of such lawsuits directed at drug and device makers has not diminished, making clear that companies in the life sciences must tread carefully when disclosing information such as the status of products in development for fear that a perceived misrepresentation could spark expensive and time-consuming litigation.
With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues.
The company conference call related to Akebia Therapeutics Inc.’s complete response letter (CRL) for vadadustat, an HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease, brought on the ongoing and perhaps inevitable comparisons with a similar product from Fibrogen Inc., rejected by the agency last August.
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