Cardiometabolic News and Research

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Welchol plus metformin combination therapy reduces A1C, LDL-C levels in type 2 diabetes patients

Results of a new study demonstrated that initial combination therapy with Welchol® (colesevelam HCl) 3.75 g/d and metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter) significantly improved glycemic and lipid control in drug-naive adult type 2 diabetes patients with high LDL cholesterol (LDL-C).

29 Jun 2010

Orexigen Therapeutics announces data from CORDiabetes trial for Contrave

Orexigen Therapeutics, Inc. today announced data from the CORDiabetes trial for Contrave (naltrexone sustained release (SR)/bupropion SR) showing that after 56 weeks of treatment, overweight or obese patients with type 2 diabetes lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo.

28 Jun 2010

USPTO grants Tethys key patent for PreDx Diabetes Risk Score test

Tethys Bioscience, Inc., a privately held company, announced today that the United States Patent and Trademark Office has granted the Company US Patent 7,723,050. The patent is directed to the company's groundbreaking PreDx™ Diabetes Risk Score (DRS) test and relates to proprietary methods for assessing the risk of developing a diabetic condition.

24 Jun 2010

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a Division of Metabolic and Endocrine Drug Products Advisory Committee meeting on December 7, 2010 to review the Company's New Drug Application (NDA) for Contrave® (naltrexone sustained release (SR)/bupropion SR) for the treatment of obesity.

24 Jun 2010

Fructose makes cells mature into fat cells in belly fat, study finds

Fructose, the sugar widely used as high-fructose corn syrup in soft drinks and processed foods, often gets some of the blame for the widespread rise in obesity. Now a laboratory study has found that when fructose is present as children's fat cells mature, it makes more of these cells mature into fat cells in belly fat and less able to respond to insulin in both belly fat and fat located below the skin.

22 Jun 2010

Data on Qnexa to be featured in six presentations at ADA annual meeting

VIVUS, Inc. today announced that data on Qnexa, an investigational drug candidate, will be featured in a total of six presentations – including an oral presentation, three moderated poster presentations and two poster presentations – during the 70th Scientific Sessions of the American Diabetes Association, being held from June 25-29, 2010 in Orlando, Florida.

22 Jun 2010

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States. LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

21 Jun 2010

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA).

17 Jun 2010

Selection of candidate in oncology programme triggers EUR 2.5 million milestone payment to Evotec

Evotec AG today announced that it has achieved a milestone as part of its research alliance with Boehringer Ingelheim and will receive a payment of EUR 2.5 million. The milestone was achieved for the selection of a candidate compound for pre-development studies in an oncology programme.

17 Jun 2010

Merck Serono, EMD Serono resume Stimuvax clinical program for NSCLC

Merck Serono, a division of Merck KGaA, and its U.S. affiliate, EMD Serono, Inc. today announced that they are resuming their Stimuvax® (BLP25 liposome vaccine) clinical program in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, STARTa and INSPIREb. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.

17 Jun 2010

Merck Serono reports long-term follow-up data of cilengitide Phase II study for recurrent glioblastoma

Merck Serono, a division of Merck KGaA, Darmstadt, Germany announced today that long-term follow-up data of a randomized Phase II study of two cilengitide doses in recurrent glioblastoma were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

7 Jun 2010

FDA accepts Orexigen's Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity.

2 Jun 2010

Evotec announces compound in strategic alliance with Boehringer Ingelheim advances into clinical trials

Evotec AG today announced that a compound in its strategic alliance with Boehringer Ingelheim has advanced into clinical trials. With the initiation of the Phase I clinical studies for this compound, Evotec will receive a milestone payment of EUR 2.0 million.

19 May 2010

Atherotech to showcase VAP Cholesterol Test at NLA Scientific Sessions 2010

Atherotech Inc. will exhibit its VAP® Cholesterol Test in booth #102 at the National Lipid Association (NLA) Scientific Sessions 2010. The meeting takes place May 13-16 at the Sheraton Hotel and Towers in Chicago.

13 May 2010

GENFIT announces milestone as compound developed in partnership enters the clinic

GENFIT (Alternext: ALGFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, today announces the achievement of a milestone in the therapeutic research collaboration with one of its strategic pharmaceutical partners.

6 May 2010

Atherotech to showcase VAP Cholesterol Test at Internal Medicine 2010

Atherotech Inc. announced it will exhibit its VAP® Cholesterol Test in booth #1305 at Internal Medicine 2010, the annual scientific meeting of the American College of Physicians (ACP). The meeting takes place April 22-24, 2010, at the Metro Toronto Convention Centre in Toronto, Canada.

20 Apr 2010

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc. announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.

1 Apr 2010

Orexigen Therapeutics reports net loss of $15.0M for three months ended December 31, 2009

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the three months and year ended December 31, 2009.

9 Mar 2010

Studies show association between high levels of vitamin D and decreased risk of heart disease

Middle aged and elderly people with high levels of vitamin D could reduce their chances of developing heart disease or diabetes by 43%, according to researchers at the University of Warwick.

16 Feb 2010

GENFIT's GFT505 exhibits potential to address unmet needs in prediabetic and diabetic patients

GENFIT, a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and neurodegenerative diseases, today announces positive results from a recently completed clinical trial demonstrating the activity of GFT505 on glucose homeostasis. Results from the clinical trial (GFT505-2094) clearly demonstrate the potential of the drug candidate to reduce global cardiovascular risk in prediabetic patients who suffer from impaired fasting plasma glucose, impaired glucose tolerance, and abdominal obesity.

28 Jan 2010

Cardiometabolic News and Research

Welchol plus metformin combination therapy reduces A1C, LDL-C levels in type 2 diabetes patients

Orexigen Therapeutics announces data from CORDiabetes trial for Contrave

USPTO grants Tethys key patent for PreDx Diabetes Risk Score test

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Fructose makes cells mature into fat cells in belly fat, study finds

Data on Qnexa to be featured in six presentations at ADA annual meeting

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Selection of candidate in oncology programme triggers EUR 2.5 million milestone payment to Evotec

Merck Serono, EMD Serono resume Stimuvax clinical program for NSCLC

Merck Serono reports long-term follow-up data of cilengitide Phase II study for recurrent glioblastoma

FDA accepts Orexigen's Contrave NDA for treatment of obesity

Evotec announces compound in strategic alliance with Boehringer Ingelheim advances into clinical trials

Atherotech to showcase VAP Cholesterol Test at NLA Scientific Sessions 2010

GENFIT announces milestone as compound developed in partnership enters the clinic

Atherotech to showcase VAP Cholesterol Test at Internal Medicine 2010

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Orexigen Therapeutics reports net loss of $15.0M for three months ended December 31, 2009

Studies show association between high levels of vitamin D and decreased risk of heart disease

GENFIT's GFT505 exhibits potential to address unmet needs in prediabetic and diabetic patients

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