Comparative Claims At RSNA Trade Show Draw FDA Ire For Bracco Diagnostics
This article was originally published in The Gray Sheet
Executive Summary
Bracco Diagnostics says it has resolved promotional violations raised in an untitled FDA letter stating that the firm made comparative claims for its MultiHance MRI contrast imaging agent, an investigational new drug, during a November 2000 trade show in Chicago.
You may also be interested in...
Scrip M&A Podcast: Which Companies Could Be Acquired Next?
The editorial team from Scrip discusses the M&A potential of various emerging biopharmas, such as Viking, Verona, Altimmune, Xenon and Crinetics.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
P&G Restores Volume Growth In Beauty, Grooming After Pricing Run
Procter & Gamble reports strong consumer spending in the US and Europe after a 3% increase in product pricing over the past year. Dragging on fiscal third-quarter results, sales of SK-II in China fell 30% for the January-March period, while lower incidence of cough and cold impacted Health Care performance.