Posted on June 30th, 2010 by Health News
PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that it has received formal Good Manufacturing Practice (GMP) certification for hGH-CTP, the company’s proprietary biobetter version of human growth hormone. GMP certification is required by the European Union (EU) clinical trials legislation as a precondition for conducting clinical trials in [...]
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Posted on June 30th, 2010 by Health News
Tranzyme Pharma announced positive top-line results today from a Phase 2, double-blind, placebo-controlled study evaluating TZP-102 capsules in diabetic patients with gastroparesis, a serious disorder characterized by the inability of the stomach to empty food efficiently. The study achieved a clinically meaningful and statistically significant improvement in critical gastroparesis-related symptoms. All three TZP-102 doses tested [...]
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Posted on June 30th, 2010 by Health News
Results from a 24-week Phase 3 clinical study demonstrated that the addition of the investigational drug dapagliflozin achieved reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c), in inadequately controlled type 2 diabetes patients who were treated with insulin (with or without oral anti-diabetes medications (OADs)), compared to placebo plus insulin (with or without OADs).
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Posted on June 30th, 2010 by Health News
Pluristem Therapeutics Inc. today announced that following its meeting with the Paul Ehrlich Institute (PEI), the German regulatory authority for advanced therapy products (ATP), the company is advancing toward designing two Phase IIb clinical trials for its placenta-derived cell therapy product, PLX-PAD, for the treatment of Critical Limb Ischemia (CLI) and Moderate-severe Claudication.
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Posted on June 30th, 2010 by Health News
The Biotechnology Industry Organization (BIO) released the following statement in reaction to the Supreme Court’s decision to uphold the lower court’s ruling in Bilski v. Kappos. “In our amicus brief, BIO urged the Supreme Court to overturn the lower court’s rigid new test for determining whether a method or process is eligible for patenting…
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Posted on June 30th, 2010 by Health News
Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced clinical trial results showing that the addition of its proprietary rHuPH20 (recombinant human hyaluronidase, PH20) enzyme to three different mealtime insulin analogs accelerated their absorption…
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Posted on June 30th, 2010 by Health News
After having announced positive results for the first year of its phase IIb/III clinical trial (VO 57.07) conducted on Actair(R) sublingual allergen immunotherapy tablets in allergic rhinitis triggered by house dust mites in April 2009, Stallergenes S.A. announces the results of the second year of this study…
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Posted on June 30th, 2010 by Health News
Novo Nordisk announced results of its STEPwise™ trial, which identified a method of intensifying insulin treatment with NovoLog® (insulin aspart [rDNA origin] injection)…
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Posted on June 30th, 2010 by Health News
Data from four pivotal Phase III clinical trials demonstrate that linagliptin achieved statistically significant and sustained reductions in blood sugar as measured by hemoglobin A1c (HbA1c),(1-4) fasting plasma glucose (FPG)(1-4) and postprandial glucose (PPG).(1,2) Boehringer Ingelheim Pharmaceuticals, Inc…
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Posted on June 30th, 2010 by Health News
Oramed Pharmaceuticals, Inc. (OTCBB: ORMP) announced that its executive management is participating in the 2010 Scientific Sessions of the American Diabetes Association currently being held in Orlando, Florida. Dr…
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