Novartis reports data at EBCC-9 for secondary survival endpoint of Afinitor trial in HR+/HER2- advanced breast cancer
Results from the secondary endpoint of the Phase III BOLERO-2 (Breast cancer trials of OraL EveROlimus-2) study of Afinitor® (everolimus) trial were presented today at the 9th European Breast Cancer Conference (EBCC-9) in Glasgow, Scotland. A median overall survival duration of 31 months was seen in the combination arm versus 26.6 months for those on exemestane monotherapy, a difference of 4.4 months (hazard ratio=0.89 [95% CI: 0.73 to 1.10]; p=0.1426)[1],[2]. This secondary endpoint did not reach the threshold of statistical significance[1]. The median overall survival is the longest reported to date in a Phase III hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer trial following prior treatment with a non-steroidal aromatase inhibitor (NSAI)[2]. 
Novo Nordisk is increasing its drug development capacity by investing 550 million Danish kroner (100 million US dollars) in a new research and development facility in Bagsværd, Denmark. The purification plant will expand the company's capacity to produce active pharmaceutical ingredients for a growing number of diabetes drugs under development. The pilot plant will be fully operational by late 2016 and will be run by CMC Supply (Chemistry, Manufacturing and Control Supply); a unit within Novo Nordisk R&D. 
Bayer HealthCare has successfully concluded the decentralized European registration procedure for its new transparent low dose contraceptive patch (gestodene/ethinylestradiol). The Health Authorities of the EU Member States will now grant national approvals for the product. "The new contraceptive patch will provide women with an additional choice of a low dose contraceptive," said Dr. Jörg Möller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. 
ViiV Healthcare announced that the European Commission has approved TivicayTM (dolutegravir), an integrase inhibitor, for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age. The Tivicay clinical development programme was comprehensive in its breadth, including people living with HIV who were new to treatment (naive), as well as those who had already been treated with other HIV medicines (experienced) and those who were infected with a virus that had developed resistance to previously available integrase inhibitors. 
AstraZeneca today announced that the European Commission (EC) has granted Marketing Authorisation to FluenzTM Tetra. Fluenz Tetra is a nasally administered four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age. The EC approval makes Fluenz Tetra the first and only intra-nasal four-strain influenza vaccine available in Europe. Historically, seasonal flu vaccines have contained three strains of influenza: two influenza A viruses (H1N1 and H3N2) and one influenza B virus. Fluenz Tetra contains an additional influenza B strain. Over the past decade, influenza B strains accounted for approximately 25 percent of the influenza strains circulating in Europe.