Berkeley Nutraceuticals warned
This article was originally published in The Tan Sheet
Executive Summary
Discrepancies between the declared weight of Berkeley's Rovicid and Enzyte tablets and their actual weight causes the products to be misbranded and "may indicate a systemic problem in your manufacturing processes," according to an Oct. 14 warning letter sent by FDA's Cincinnati office. FDA also cited the firm for promoting its manufacturing facility as "certified by [FDA] for Good Manufacturing Practices," a false statement causing Berkeley's products to be further misbranded. Moreover, heart disease treatment claims for Rovicid and age-related macular degeneration claims for Rogisen cause the products to be unapproved new drugs...
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.