Local News

• FDA accepts Vanda Pharmaceuticals iloperidone resubmission and sets new action date  Vanda Pharmaceuticals reported that the FDA has accepted Vanda's resubmission of the iloperidone New Drug Application (NDA). Vanda's resubmission was a Complete Response to the not approvable action letter that the company received on July 25, 2008.
  Vanda Pharmaceuticals Inc. 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• Pfizer withdraws application to switch Viagra to non-prescription status in Europe  Pfizer announced that it has withdrawn its application to switch the legal status of the 50 mg tablet strength of Viagra from 'prescription only' to 'non-prescription' in the European Union (EU).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  
• PharmAthene signs agreement with Medison Pharma  PharmAthene, a biodefense company developing medical countermeasures against biological and chemical threats, announced that it has signed an agreement with Medison Pharma, to commercialize its biodefense products in Israel.
  PharmAthene November 19, 2008  
• More seek share of smaller funds from Maryland Stem Cell Research Commission  The Maryland Stem Cell Research Commission has received 187 letters of intent from researchers vying to win $18 million in state funding. Officials said the level of interest outpaces the 127 requests the commission received last year.
  Baltimore Business Journal November 19, 2008  Sue Schultz
• 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
• MiddleBrook Pharmaceuticals hires key commercial team members  MiddleBrook Pharmaceuticals announced it has hired key commercial team members. Frank L. Koos has joined MiddleBrook Pharmaceuticals as senior vice president, sales & business development.
  MiddleBrook Pharmaceuticals, Inc. November 19, 2008  

   (next 10 articles)