Dyslipidemia News and Research

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Dyslipidemia is a disruption in the amount of lipids in the blood.

VIVUS seeks marketing approval of QNEXA in the EU

VIVUS, Inc. today announced that the company filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for QNEXA® (phentermine/topiramate) Controlled Release Capsules in the European Union (EU). The proposed indication in the EU is for the treatment of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a mildly hypocaloric diet.

20 Dec 2010

Amarin completes patient randomization in AMR101 Phase 3 trial in patients with high triglyceride levels

Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported the completion of patient randomization for its ANCHOR trial, a pivotal Phase 3 trial of AMR101. The Company indicated that it anticipates reporting top-line results from this trial in Q2 2011.

16 Dec 2010

Researchers introduce new class of drugs for HCV patients

To improve the care for individuals infected with the hepatitis C virus, a major health problem and a leading cause of chronic liver disease around the world, nearly 200 international hepatitis experts have taken an important step in escalating the introduction of a new class of targeted therapies for HCV – direct-acting antivirals.

15 Dec 2010

VIVUS submits briefing document to FDA in effort to secure regulatory approval for QNEXA

VIVUS, Inc. today announced that the company, as part of its continuing effort to secure regulatory approval for QNEXA® in the U.S., submitted a briefing document to the Food and Drug Administration (FDA) designed to address items in the FDA's Complete Response Letter (CRL), issued on October 28, 2010. The company also announced that the Endocrine and Metabolic Division of the FDA has granted VIVUS a meeting in the second half of January 2011 to discuss the content of the proposed resubmission.

14 Dec 2010

Ligand Pharmaceuticals reports preclinical study data on erythropoietin receptor agonists

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced data from a preclinical study on the erythropoietin (EPO) receptor agonist LG5640 at the upcoming 52nd American Society of Hematology (ASH) Annual Meeting being held in Orlando, Florida at the Orange County Convention Center, December 4 - 7, 2010.

6 Dec 2010

Merck to present multiple clinical studies of dinaciclib at ASH Annual Meeting

Ligand Pharmaceuticals Incorporated today announced that multiple clinical studies of dinaciclib (SCH 727965) will be presented by Merck at the upcoming 52nd American Society of Hematology Annual Meeting being held in Orlando, Florida at the Orange County Convention Center, December 4-7, 2010.

4 Dec 2010

FDA Advisory Committee votes in favor of expanded use of LAP-BAND gastric band

Allergan, Inc. (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee has recommended with an 8-2 vote that the FDA extend the currently approved use of the LAP-BAND® System, Allergan's gastric band, on the basis of a favorable benefit-risk profile for weight reduction in obese adults who have failed more conservative weight reduction alternatives and have a Body Mass Index (BMI) of at least 35 or a BMI ≥30 and at least one comorbid condition.

4 Dec 2010

Amarin reports top-line results from AMR101 Phase 3 trial for treatment of high triglycerides

Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101.

29 Nov 2010

Impax initiates patent challenge in connection with SIMCOR

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed in connection with SIMCOR® (niacin/simvastatin) extended-release tablets, 1000/20 mg.

26 Nov 2010

Omthera reaches agreement with FDA on SPA for Epanova Phase III trial in patients with very high triglycerides

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of its planned Phase III registration clinical trial of Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

22 Nov 2010

Surveyed cardiologists, PCPs perceive Crestor comparable to Lipitor in ability to reduce mortality

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that in the treatment of dyslipidemia, surveyed cardiologists and primary care physicians (PCPs) now perceive AstraZeneca's Crestor's ability to reduce mortality comparable to Pfizer's Lipitor. This finding has changed from Decision Resources' 2009 analysis in which surveyed cardiologists viewed Lipitor as significantly better on this end point.

20 Nov 2010

Ligand reverse stock split becomes effective

Ligand Pharmaceuticals Incorporated today announced that its previously disclosed 1-for-6 reverse stock split has become effective, and will be reflected in the share price beginning today.

20 Nov 2010

Amarin reports $31.4 million cash balance for third quarter 2010

Amarin Corporation plc, a clinical-stage biopharmaceutical company focused on cardiovascular disease, today reported its financial and operational results for the three-month period ended September 30, 2010.

10 Nov 2010

Omthera initiates ECLIPSE study for treatment of high triglycerides

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced the initiation of a randomized, open-label, four-way cross-over pharmacokinetics study to evaluate the bioavailability of Epanova, Omthera's lead compound for the treatment of very high triglycerides, in comparison to Lovaza, the leading prescription Omega-3.

9 Nov 2010

TransTech Pharma, High Point receive $1.96 million grants under QTDP program

TransTech Pharma, Inc. and High Point Pharmaceuticals, LLC. today announced that they have been awarded cash grants totaling $1.96 million under the U.S. Government's Qualifying Therapeutic Discovery Project program.

8 Nov 2010

CaPre drug candidate effective in managing impaired glucose tolerance

Neptune Technologies & Bioressources Inc. subsidiary Acasti Pharma Inc. reports preclinical results showing that its leading drug candidate CaPre, performed significantly better than the currently marketed drug, Lovaza, at managing impaired glucose tolerance (IGT) a serious pre-diabetic state associated with increased risk of diabetes and heart disease.

4 Nov 2010

Ligand awarded $1,955,834 federal grant under Patient Protection and Affordable Care Act

Ligand Pharmaceuticals Incorporated today announced it has been awarded $1,955,834 in immediately available funds from the U.S. government under HR: 3590 - Patient Protection and Affordable Care Act. The award comprises separate payments of approximately $245,000 for each of eight drug development programs at Ligand.

2 Nov 2010

GSK's Revolade receives Japanese approval for treatment of chronic ITP

Ligand Pharmaceuticals Incorporated today announced its partner GlaxoSmithKline was granted approval from the Japanese Ministry of Health, Labour and Welfare for Revolade® (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP).

2 Nov 2010

VIVUS receives FDA CRL for QNEXA NDA

VIVUS, Inc. announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA® (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

29 Oct 2010

Metabolon receives patent for biomarkers to determine PPAR-affecting drugs

Metabolon, Inc., leaders in global metabolomics, biomarker discovery and biochemical analysis, announced today the grant of US Patent 7,807,138 entitled "Biomarkers of Metabolic Responses to Hepatic Drugs". The USPTO awarded the patent to Metabolon on October 5, 2010. This is the 13th patent issued to Metabolon and the second in its portfolio of biomarker patents.

21 Oct 2010