Hyperglycemia News and Research

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Hyperglycemia occurs when you have a higher than usual level of glucose in your blood. This can happen shortly after you have eaten a big meal and is not a problem if your glucose level returns to normal. Cells remove glucose from the blood in response toinsulin. If your pancreas doesn't make enough insulin, glucose can't enter the cells and remains in the blood. Blood glucose levels can also get too high if cells areunable to respond to insulin properly (insulinresistance). Without glucose, your cells are unable to make energy and can't function properly.

ARIAD's oral ridaforolimus improves PFS in patients with metastatic endometrial cancer

Pharmaceuticals, Inc. today announced interim results of a randomized, open‐label, active-control multicenter Phase 2 study of oral ridaforolimus, an investigational mTOR inhibitor, in patients with metastatic or recurrent endometrial cancer. Based on this interim analysis, the study demonstrated a statistically significant improvement in the primary endpoint of median progression-free survival (PFS) in patients receiving single-agent ridaforolimus compared to patients receiving standard-of-care treatment.

26 Oct 2010

MannKind begins MKC1106-MT Phase 2 trial for advanced melanoma

MannKind Corporation today announced the first patient has been dosed in a phase 2 clinical trial of the novel, investigational cancer vaccine MKC1106-MT. As a part of MannKind's cancer immunotherapy program, this phase 2 study will evaluate the safety, tolerability, immune response and clinical response of MKC1106-MT in patients with advanced melanoma.

20 Oct 2010

Type 2 diabetes and insulin use associated with CRC risk in men, but not women

There is an association between type 2 diabetes mellitus and colorectal cancer (CRC) among men, but not women, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute.

19 Oct 2010

Study finds link between blood sugar levels and mortality risk in diabetic patients after non-cardiac surgeries

A clinical study presented at ANESTHESIOLOGY 2010 discovered that diabetics who presented for non-cardiac surgery with near normal blood sugar levels were at increased risk of death, as compared with their non-diabetic counterparts.

19 Oct 2010

Halozyme Therapeutics to advance core proprietary programs through key clinical inflection points

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced a focusing of its resources on advancing its core proprietary programs through key clinical inflection points in 2011 and 2012, and supporting strategic alliances with Roche and Baxter such as validation of Halozyme's commercial scale manufacturing process to produce kilogram quantities of enzyme.

12 Oct 2010

Afinitor-Sandostatin LAR Depot combination extends median PFS in patients with advanced carcinoid tumors

A Novartis Pharmaceuticals Corporation Phase III study of Afinitor® (everolimus) tablets in combination with Sandostatin® LAR Depot (octreotide acetate for injectable suspension) extended median progression-free survival (PFS), or time without tumor growth, in patients with advanced carcinoid tumors compared to taking octreotide LAR alone.

11 Oct 2010

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

6 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

Phase 3 clinical study demonstrates efficacy of metformin therapy in type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced results from a randomized, double-blind Phase 3 clinical study in adults with type 2 diabetes inadequately controlled on metformin therapy alone.

24 Sep 2010

Novartis' SOM230 reduces cortisol levels in Cushing's disease patients

Novartis Pharmaceuticals Corporation announced today that the results of a Phase III study of SOM230 (pasireotide) showed a reduction in cortisol levels in patients with Cushing's disease, a condition in which a benign (non-cancerous) pituitary tumor causes the adrenal glands to produce excess cortisol and can be fatal. Results will be presented at the 14th Congress of the European Neuroendocrine Association (ENEA).

22 Sep 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010

Dapagliflozin added to glimepiride therapy reduces HbA1c in adult type 2 diabetes patients

Bristol-Myers Squibb Company and AstraZeneca today announced results from a randomized, double blind Phase 3 clinical study, which demonstrated that the addition of the investigational drug dapagliflozin to existing glimepiride (sulphonylurea) therapy produced significant reductions in glycosylated hemoglobin levels (HbA1c) in adult patients with type 2 diabetes compared to glimepiride alone.

20 Sep 2010

Oramed Pharmaceuticals announces clinical trial results of ORMD-0801 capsule in Type I diabetics

Oramed Pharmaceuticals Inc. announced today successful results in an exploratory clinical trial testing the effectiveness of its oral insulin capsule (ORMD-0801) in Type I diabetes patients suffering from uncontrolled diabetes.

15 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

Halozyme second-quarter revenue increases to $3.2 million

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the second quarter ended June 30, 2010.

7 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Arcelis immunotherapy effective in treating autoimmune diseases: Study

Argos Therapeutics today announced that its Arcelis immunotherapy targeted at diabetes demonstrated potential for preventing and treating the disease in non-obese diabetic (NOD) mice, according to a peer-reviewed article published in Molecular Therapy.

4 Aug 2010

MannKind second-quarter total operating expenses decrease to $16.0 million

MannKind Corporation today reported financial results for the second quarter ended June 30, 2010.

2 Aug 2010