GDUFA II negotiations: CMOs to pay one third of facility fees
The Pharma & Biopharma Outsourcing Association (PBOA) has helped negotiate reduced fees for CMOs in the FDA’s proposed reauthorisation of the Generic Drug User Fee Amendment (GDUFA).
Archives for September 28, 2016
AbbVie API plant opens in Singapore as first part of larger $320m site
AbbVie has opened an oncology and women’s health API plant, part of its planned 120,000m2 small and large molecule manufacturing site in Singapore.
Charles River continues CRO buy up, acquires Agilux Labs for $64m
Charles River Laboratories has acquired Worcester, MA-based contract research organization (CRO) Agilux Laboratories, further bolstering the company’s early-stage services.
Cel-Sci's Multikine Phase III trial placed on hold by US FDA
The US FDA has placed a Phase III trial for Cel-Sci’s head and neck cancer candidate on clinical hold.
MedPharm opens US facility in Research Triangle
MedPharm’s new US-based subsidiary, MP Pharma Services, has opened in Research Park Tringle to serve the growing global dermatology market.
QPS cardiac collaboration to extend sponsor networks
QPS Holdings LLC and G-CURE BV will collaborate on cardiovascular drug development programs for pharmaceutical companies.