Local News

• Tibotec begins enrollment in Europe for Phase III trial of telaprevir  Tibotec BVBA announced that it has begun enrolling patients in its phase III study of telaprevir (VX-950), an investigational protease inhibitor (PI), in patients with chronic genotype 1 hepatitis C virus (HCV) for whom the current standard treatment has not been successful.
  Johnson & Johnson November 20, 2008  
• Tibotec presents interim findings for TMC435, an investigational genotype 1 HepC treatment  New clinical data show antiviral activity of TMC435, an investigational protease inhibitor (PI) being developed by Tibotec BVBA for the treatment of chronic hepatitis C virus (HCV) infection.
  Johnson & Johnson November 20, 2008  
• AstraZeneca to divest Nordic over-the-counter portfolio  AstraZeneca announced the divestment to GlaxoSmithKline of a portfolio of over-the-counter (OTC) products predominantly sold in Sweden. The decision reinforces AstraZeneca's strategy to focus on innovation in prescription medicines.
  AstraZeneca November 20, 2008  
• Ortho Biotech announces NDA submission for trabectedin  Ortho Biotech Products announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer (ROC).
  Johnson & Johnson November 20, 2008  
• Pfizer withdraws application to switch Viagra to non-prescription status in Europe  Pfizer announced that it has withdrawn its application to switch the legal status of the 50 mg tablet strength of Viagra from 'prescription only' to 'non-prescription' in the European Union (EU).
  Pfizer Inc. November 20, 2008  
• AstraZeneca granted temporary restraining order in PULMICORT RESPULES patent litigation  On 19 November 2008, AstraZeneca was granted a Temporary Restraining Order (TRO) by the United States District Court for the District of New Jersey, halting sales of Teva's budesonide inhalation suspension product, a generic version of AstraZeneca's PULMICORT RESPULES treatment.
  AstraZeneca November 20, 2008  
• AstraZeneca to realign supply chain to improve productivity and move closer to customers  AstraZeneca has announced proposed changes to its global manufacturing and supply chain operations as part of its ongoing programme to improve efficiency across the business.
  AstraZeneca November 20, 2008  
• Amgen, Takeda and Millennium provide update on Phase 3 trial of motesanib  Amgen and Millennium announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been temporarily suspended.
  Amgen November 19, 2008  
• AstraZeneca enters agreement for authorized generic Pulmicort Respules  AstraZeneca announced that it has entered into a supply and distribution agreement with Par Pharmaceutical to distribute an authorized generic version of budesonide inhalation suspension in the United States in response to the launch 'at risk' of a generic version of this product by Teva.
  AstraZeneca November 19, 2008  
• FDA opens 1st office in China  U.S. officials are launching a new strategy to improve the safety of the vast range of foods and other products imported from China and other countries to the United States. The Food and Drug Administration is opening its first office outside the United States in Beijing.
  Austin American-Statesman (Texas) November 19, 2008  Craig Simons

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