Bayer Initiates Phase III Trial of Regorafenib in Metastatic or Unresectable Gastrointestinal Stromal Tumors
Bayer HealthCare, Germany, has started to enroll patients in GRID, an international Phase III trial to evaluate its investigational compound regorafenib (BAY 73-4506) for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed after at least imatinib and sunitinib as prior treatments. Regorafenib is an oral multi-kinase inhibitor with a distinct profile targeting angiogenic (VEGFR, TIE-2), stromal (PDGFR-β) and oncogenic (RAF, RET and KIT) receptor tyrosine kinases.(1) 
Novo Nordisk has been awarded the 2010 GOOD DESIGN(TM) Award[1] for NovoTwist(R), the innovative needle designed for use with the Novo Nordisk insulin delivery device FlexPen(R) and Victoza(R) (liraglutide) Pen. The GOOD DESIGN(TM) Award[1] is judged based on design innovation beyond what is considered ordinary, and on whether a product can enrich society and people's lives. 
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) has included roflumilast (Daxas®) as a new treatment option in its COPD management guidelines. A section on the new class, phosphodiesterase 4 (PDE4) inhibitors, describes the efficacy of roflumilast in patients with COPD. 'The Global Strategy for Diagnosis, Management and Prevention of COPD', provides evidence-based guidelines for COPD management and is updated annually by a committee of leading COPD experts. 
GlaxoSmithKline (GSK) issued the following response regarding a 60 Minutes program on January 2 that focused on a manufacturing facility in Puerto Rico which was formerly owned by the company. GSK regrets the manufacturing issues at the Cidra facility, which were inconsistent with GSK's commitment to manufacturing quality. It is important to note, however, that the issues outlined in the 60 Minutes story occurred in the past - between 2001 and early 2005 - and related to one manufacturing facility. 
Novartis has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Bexsero® (Multi-Component Meningococcal B Vaccine; formerly known as 4CMenB). Upon approval, Bexsero will be the first broad-coverage vaccine licensed for use against disease caused by meningococcal serogroup B bacteria (MenB) in all European Union (EU) and European Economic Area (EEA) countries[1,2]. 
AstraZeneca has notified Abbott that it will discontinue the development of CERTRIAD (rosuvastatin calcium and fenofibric acid), which was being investigated for the treatment of mixed dyslipidemia. This means the co-development and license agreement with Abbott will end on 22 January 2011. A Complete Response Letter (CRL) for the CERTRIAD New Drug Application (NDA) was received from the U.S. Food and Drug Administration (FDA) on 30 March 2010.