Boehringer Ingelheim Initiates Phase III Clinical Trial with Novel Oral Agent in Advanced Breast Cancer
Boehringer Ingelheim announced the initiation of a phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, afatinib, for the treatment of patients with advanced (metastatic) breast cancer. Afatinib is an oral compound (taken as a tablet), which is a next generation, targeted therapy, that irreversibly inhibits both, the epidermal growth factor receptor (EGFR/HER1) and the human epidermal receptor HER2, which are involved in tumour growth and spread(1).
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"The Merck Way" Presented in a New Image Brochure and Film
What makes Merck what it is, what distinguishes it from other companies? Answers to these questions can now be found in an image brochure entitled "The Merck Way". Dr. Walter Huber, Head of Corporate Communications, explained: "The 28-page illustrated brochure presents the company's culture, values, history, strategy and objectives as well as the business sectors and the ownership structure. Customers, applicants, investors, journalists and neighbors will find out who and what Merck is."
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European Union Approves MSD's New Single Dose 'Ivemend'®
Merck (known as MSD outside the United States and Canada) today announced that the European Union has granted marketing approval for a new, single dose regimen of 'Ivemend'® (fosaprepitant) 150 mg. Fosaprepitant is used in adults in combination with other antiemetic medicines for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin (HEC)-based chemotherapy and moderately emetogenic chemotherapy (MEC).
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Novartis announces Russian regulatory approval for Gilenya®
The Russian health authority, the Federal Service on Surveillance in Healthcare and Social Development, has granted approval for Gilenya® (fingolimod) 0.5 mg once-daily oral therapy for the treatment of relapsing remitting multiple sclerosis (MS). Approximately 85% of patients with MS are estimated to have the relapsing remitting form at the onset of disease[1]. Russia is the first country to approve Gilenya, providing a new treatment option offering significant efficacy for patients in the convenience of an oral capsule.
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LEVITRA 10mg Orodispersible Tablet for the Treatment of Erectile Dysfunction approved in Europe
The European Commission has approved a new formulation of Levitra® (vardenafil HCI). Levitra 10mg orodispersible tablet will be the first erectile dysfunction (ED) medication available in this novel and convenient formulation. In contrast to other drugs of the same class, Levitra 10mg orodispersible tablet allows men a discreet and convenient intake without water, dissolving on the tongue within seconds with a minty flavour.
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BBC Panorama: "A Risk Worth Taking?" Programme. GlaxoSmithKline Right of Reply Statement
Patient safety is our first priority. We strongly refute any allegation that our actions have put patients at risk. We have carried out an extensive research programme, involving more than 50,000 patients to analyse the safety and benefits of Avandia. All the results from our research programme have been given to the regulatory authorities worldwide and we are fully committed to being open about the results of all our clinical research.
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Reports of narcolepsy in Europe following vaccination with Pandemrix™
GSK initially became aware of possible cases of narcolepsy following vaccination with the adjuvanted H1N1 pandemic vaccine Pandemrix through adverse event reports received by the Swedish Medical Products Agency, and subsequently via media reports in Finland. Information on the individual cases remains limited at present, but GSK is conducting its own investigation in an effort to gather as much additional data as possible regarding the reported cases, and is working closely with key regulatory authorities, including the European Medicines Agency (EMA).
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