Lilly CEO Says Biopharmaceuticals Should Be Included in Transatlantic Trade and Economic Discussions
John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Eli Lilly and Company (NYSE: LLY), urged that biopharmaceuticals be included in transatlantic trade and economic discussions. Lechleiter participated in the American Council on Germany's conference on "The Transatlantic Partnership in the 21st Century," joining U.S. Fed Chairman Paul Volcker; German State Secretary in the Federal Finance Ministry Jorg Asmussen; and Handlesblatt editor-in-chief Gabor Steingart in a panel discussion.
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Novartis drug Afinitor® met primary endpoint of Phase III study in women with advanced breast cancer
Novartis announced that an interim analysis of a pivotal Phase III study showed Afinitor® (everolimus) tablets in combination with exemestane significantly extended progression-free survival (PFS), or time without tumor growth, when compared to placebo plus exemestane in women with advanced breast cancer. The trial was stopped early after interim results showed the primary endpoint of PFS was met. The study included postmenopausal women with ER+HER2- metastatic breast cancer whose disease has progressed, despite initial endocrine therapy.
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Merck Received European Approval for Pen Injectors for Fertility Treatment
Merck KGaA announced that the European Commission (EC) has granted an approval for three pre-filled, ready-to-use pen injectors for fertility treatment. This "family of pens" is designed for self-administration of the liquid formulations of its three recombinant gonadotropins used in fertility treatments: Gonal-f® (follitropin alfa) 300 IU, 450 IU and 900 IU, Luveris® (lutropin alfa) 450 IU and Ovidrel®/Ovitrelle® 250 micrograms (choriogonadotropin alfa).
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Bayer advances research in the area of pulmonary hypertension
Bayer HealthCare is working with the Ludwig Boltzmann Institute (LBI) for Lung Vascular Research in the research area of lung vascular diseases - especially pulmonary hypertension. Other partners include the German medical device manufacturer NEBU-Tec and the Austrian Academy of Sciences. The research facility is also sponsored by Bayer and belongs to the Ludwig Boltzmann Gesellschaft (LBG). The LBI for Lung Vascular Research is located at the Medical University of Graz, which is also a partner of the LBI.
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Mipomersen Data Presented at European Atherosclerosis Society Congress
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that two additional analyses from phase 3 studies of mipomersen were presented at the 79th European Atherosclerosis Society (EAS) Congress. In a presentation entitled "Mipomersen, A First-in-Class ApoB Synthesis Inhibitor, Lowers Lp(a) in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) and High Baseline Lp(a): Results from two Phase 3 studies," Elisabeth Steinhagen-Thiessen, M.D., of the Lipid Ambulatory Clinic, University of Berlin, Germany, focused on the effects of mipomersen on elevated Lp(a) levels.
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Amgen Receives Positive CHMP Opinion for Vectibix® (Panitumumab) in Combination with Chemotherapy
Amgen (NASDAQ: AMGN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Vectibix® (panitumumab) be approved for use in the European Union (EU) in first-line in combination with FOLFOX and in second-line in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) for patients with wild-type KRAS metastatic colorectal cancer (mCRC), following a successful re-examination procedure by Amgen.
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Novartis drug Votubia® recommended by CHMP for approval in the EU
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Votubia® (everolimus) tablets* for the treatment of patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC), who require therapeutic intervention but are not amenable to surgery. If approved, Votubia will be the first medication available for these patients in the European Union (EU).
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