Industry News

• Roche’s etrolizumab meets primary endpoint of clinical remission in ulcerative colitis   Roche announced that the EUCALYPTUS phase II induction study of etrolizumab in patients with moderate-to-severely active ulcerative colitis met its primary endpoint of clinical remission at week 10. The data showed etrolizumab was well tolerated with no clinically significant safety concerns.
  May 18, 2013  
• Consuming coffee linked to lower risk of detrimental liver disease, Mayo Clinic finds  Regular coffee consumption is associated with reduced risk of primary sclerosing cholangitis (PSC), an autoimmune liver disease, Mayo Clinic research shows. PSC is an inflammatory disease of the bile ducts that results in inflammation and subsequent fibrosis that can lead to cirrhosis of the liver.
  May 18, 2013  
• Progenics Pharmaceuticals added to NASDAQ Biotechnology Index  Progenics announced that it has been selected for addition to the NASDAQ Biotechnology Index®. The NASDAQ Biotechnology Index is designed to track the performance of a set of NASDAQ Stock Market-listed securities classified as either Biotechnology or Pharmaceuticals.
  May 17, 2013  
• Afinitor® extended time without disease progression in women with advanced breast cancer  Results of a pivotal Phase III trial in women with HER2 positive advanced breast cancer showed that Afinitor® (everolimus) tablets in combination with trastuzumab (Herceptin®*) and vinorelbine significantly extended progression-free survival and met the primary endpoint.
  May 17, 2013  
• Cholesterol not reliable indicator of heart attack risk in kidney-disease patients   High cholesterol typically pinpoints those patients at risk of heart attack. But recently published medical research from the U of A shows that cholesterol level testing failed to accurately predict which patients with kidney disease or weak kidney function were at high risk for heart failure.
  May 17, 2013  Raquel Maurier
• Study identifies new approach to improving treatment for MS and other conditions  Working with lab mice models of multiple sclerosis, UC Davis scientists have detected a novel molecular target for the design of drugs that could be safer and more effective than current FDA-approved medications against MS. The findings are published in the journal EMBO Molecular Medicine.
  May 17, 2013  
• SIMPONI(R) (Golimumab) receives FDA approval for ulcerative colitis  Janssen announced the FDA has approved SIMPONI® (golimumab) for treatment of moderately to severely active ulcerative colitis in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates.
  May 17, 2013  
• Sanofi reports positive topline results from pivotal phase III JAKARTA study  Sanofi announced that the pivotal study, JAKARTA, examining the selective JAK2 inhibitor SAR302503 for myelofibrosis, met its primary endpoint in both dose groups. The primary endpoint assessed the proportion of patients achieving >/=35% reduction of spleen volume.
  May 17, 2013  
• Impax launches authorized generic of Zomig (zolmitriptan) tablets in U.S.  Impax announced that its generics division, Global Pharmaceuticals, commenced shipment of authorized generic Zomig® (zolmitriptan) tablets and orally disintegrating tablets, 2.5 mg and 5 mg, in the U.S., as part of a Distribution, License, Development and Supply Agreement with AstraZeneca.
  May 17, 2013  
• Thoratec announces FDA approval of HeartMate II® Pocket ControllerTM  Thoratec announced it has received approval from the FDA to market the HeartMate II® Pocket Controller™, the small, smart, safe face of the HeartMate II LVAD System. The Pocket Controller is designed to support the active lifestyles that patients.
  May 17, 2013  

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