FDA investigators are continuing to find contamination problems and inadequate testing, according to 20 warning letters issued in the first half of 2013, as well as a troubling trend of repeat observations at Baxter, Hospira and Apotex. Observers say to expect more sterility concerns in future warning letters, particularly involving mold, as FDA ramps up GMP enforcement at compounding pharmacies.

As many as 450,000 units under an array of brands are being recalled by Kao Corporation’s Kanebo Cosmetics unit following reports suggesting that the company’s Rhododenol brightening ingredient can leave white blotches on skin.

As many as 450,000 units under an array of brands are being recalled by Kao Corporation’s Kanebo Cosmetics unit following reports suggesting that the company’s Rhododenol brightening ingredient can leave white blotches on skin.

After spending a decade developing its technology and product development capabilities, centered on testing for human papillomavirus, the cause of cervical cancer, Digene Corp. is growing its top line and finally gaining visibility. Now, the question is whether it can validate its test clinically and secure its market position, which means dislodging an entrenched cytology infrastructure. If successful, the company could become a superstar. On the other hand, its proprietary position could be undermined by other cervical cancer markers that appear downstream of initial HPV infection and have a higher correlation with disease. And Digene's focus on the HPV product opportunity has limited its efforts in developing its core technology at a time when other companies are dedicating significant resources to similar efforts.