Issue link: https://www.e-digitaleditions.com/i/819216
Priviate-equity firms to acquire Stada BAD VILBEL, Germany—Stada Arzneimittel, a German pharmaceuti- cal manufacturer, agreed to sell itself to private-equity firms Bain Capital, Boston, MA, and Cinven, London, UK. The acquisition would give the firms more access to German and Russian generic and OTC markets. Bain and Cinven have agreed to refrain from layoffs for the next 4 years and to honor Stada's union contracts. Astellas acquires Ogeda TOKYO, Japan—Astellas Pharma acquired Ogeda, Gosselies, Belgium, a clinical-stage pharmaceutical dis- covery company. As part of this acquisition, Astellas will also acquire Ogeda's fexolinetant, a molecule for oral delivery that studies show could be used as a non-hormonal treatment of hot flashes in menopausal women. FDA extends eCTD filing deadline to 2018 SILVER SPRINGS, MD—The FDA extended the deadline for phar- maceutical manufacturers to submit master files in electronic common technical document (eCTD) format to May 5, 2018. Based on submitted master files, uptake data, and indus- try feedback, the Agency postponed the May 5, 2017, deadline because it could have led to high rejection rates of master files, and thus slow the FDA review processes. FDA approves more NDAs than EMA WALTHAM, MA—Between 2011 and 2015, the FDA approved more pharmaceuticals in less time than the European Medicines Agency (EMA), according to a study in the New England Journal of Medicine. The results of the research show that during those 4 years, the Agency approved 170 new drug applications, while the EMA approved 140. Additionally, the FDA approved pharmaceuticals faster than the EMA, with a median review time of 306 days versus 383 days. 8 May 2017 Tablets & Capsules sule opics and aining t tr an select on-line c s oup Individuals or gr Cap & t able Table erful w o P -learning E e xperts alik s and e beginner ͕ ŵ Ă Ğ ƚ Ő Ŷ ŝ ƌ Ƶ ƚ Đ Ă Ĩ Ƶ Ŷ Ă ŵ Ğ ƌ Ɵ Ŷ Ğ Ğ Ś ƚ ƌ Ž & Ŷ Ž Ɵ Ğ ů Ɖ ŵ Ž Đ Ĩ Ž Ğ ƚ Ă Đ Į Ɵ ƌ Ğ Đ Ă Ğ ǀ ŝ Ğ Đ Ğ ƌ opics and aining t tr Ɵ Ƶ Ğ Đ Ś Đ Ğ ƚ ŵ Ž Đ ͘ Ɛ ů Ă Đ Ɵ