Chromosomal Crossover News and Research

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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

MAP Pharmaceuticals reports positive results from LEVADEX QT trial for migraine

MAP Pharmaceuticals, Inc. today reported successful results from a thorough QT trial of its investigational LEVADEX™ orally inhaled migraine therapy. The trial evaluated the potential of a supra-therapeutic dose to cause an increase in the QT interval. Results of the trial showed that a supra-therapeutic dose of LEVADEX does not increase QTc intervals. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

8 Nov 2010

XenoPort third quarter net loss decreases to $19.9 million

XenoPort, Inc. announced today financial results for the third quarter and nine months ended September 30, 2010. Revenues for the third quarter were $0.4 million, compared to $0.4 million for the same period in 2009. Net loss for the third quarter was $19.9 million, compared to a net loss of $24.4 million for the same period in 2009.

8 Nov 2010

Pisgah Labs receives QTDP grant to accelerate abuse deterrent technology

Pisgah Labs, Inc., an innovative drug development and active ingredient manufacturer located in Western North Carolina, has received a substantial federal grant.

4 Nov 2010

FDA grants orphan drug designation to Discovery's KL4 surfactant for CF treatment

Discovery Laboratories, Inc. today announced that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to Discovery's KL4 surfactant for the treatment of cystic fibrosis (CF).

1 Nov 2010

Agile presents AG200-15 contraceptive patch Phase 2 clinical study results at 66th ASRM

Agile Therapeutics announced results today from a Phase 2 clinical study of AG200-15, Agile's weekly contraceptive patch containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG). According to the clinical findings, AG200-15 provides a low daily dose of estrogen equivalent to 30 micrograms EE, similar to that in low-dose, oral contraceptive (OC) pills.

26 Oct 2010

Talecris announces publication of PROLASTIN-C study results for AAT deficiency in BML journal

Talecris Biotherapeutics today announced the publication of results from a study showing that PROLASTIN-C (Alpha1-Proteinase Inhibitor [Human]) (A1PI) is as effective as PROLASTIN (Alpha1-Proteinase Inhibitor [Human]) in raising levels of alpha-1 protein in patients with alpha1-antitrypsin (AAT) deficiency.

22 Oct 2010

First Edition: October 19, 2010

Today's major health policy headlines include reports about the latest developments in Virginia's court challenge against the health law, a U.S. government lawsuit targeting Michigan Blue Cross Blue Shield for anti-trust activities and a study about the Department of Health and Human Services' Hospital Compare.

19 Oct 2010

Hyperion's HPN-100 granted FDA Fast Track Designation for urea cycle disorders

Hyperion Therapeutics, Inc. announced today that its investigational compound glycerol phenylbutyrate (HPN-100) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as adjunctive therapy for the chronic management of urea cycle disorders. Hyperion recently completed its phase III trial which was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. The Company plans to announce results from that trial later this year.

18 Oct 2010

Discovery Labs to present lucinactant Phase 2a clinical study results at NACFC Conference

Discovery Laboratories, Inc. today announces that the Phase 2a clinical study of aerosolized KL4 surfactant (lucinactant) in patients with cystic fibrosis (CF) has completed and the results from the study will be presented at the upcoming North American Cystic Fibrosis Conference (NACFC; October 21-23, 2010).

15 Oct 2010

Scientists identify root cause of chromosomal errors and gene diversity

A team led by a scientist at the University of Pittsburgh School of Medicine has discovered a regulatory protein that influences where genetic material gets swapped between maternal and paternal chromosomes during the process of creating eggs and sperm. The findings, which shed light on the roots of chromosomal errors and gene diversity, appear in tomorrow's issue of Nature.

14 Oct 2010

Targacept announces top-line results from AZD1446 Phase 2 clinical trial for ADHD

Targacept, Inc. today announced top-line results from a Phase 2 clinical trial of AZD1446 conducted by AstraZeneca in adults with attention deficit/hyperactivity disorder (ADHD).

8 Oct 2010

Archimedes publishes FPNS clinical study results in Pain journal

Archimedes Pharma US Inc. today announced publication of results from a pivotal clinical study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain (BTCP).

5 Oct 2010

Walnuts and walnut oil reduce blood pressure during stress: Study

A diet rich in walnuts and walnut oil may prepare the body to deal better with stress, according to a team of Penn State researchers who looked at how these foods, which contain polyunsaturated fats, influence blood pressure at rest and under stress.

4 Oct 2010

Swedish Medical Center researcher receives NIH grants to study pregnancy complications

Michelle A. Williams, Sc.D., co-director and principal investigator at the Center for Perinatal Studies at Swedish Medical Center in Seattle and Professor of Epidemiology and Global Health at the University of Washington, has received two grants totaling $5.6 million for research into complications affecting pregnancy.

1 Oct 2010

XenoPort to present XP21279 clinical trial data at World Parkinson Congress meeting

XenoPort, Inc. announced today that new data from its first clinical trial of XP21279, a Transported Prodrug of L-Dopa, in Parkinson's disease patients will be presented at the upcoming World Parkinson Congress meeting in Glasgow, Scotland.

29 Sep 2010

KAI Pharmaceuticals enrolls patients in Phase 1b study of KAI-4169 for treatment of SHPT

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced enrollment of the first patients in a Phase 1b study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of secondary hyperparathyroidism, which is a frequent and serious complication of end-stage renal disease.

27 Sep 2010

MediciNova receives FDA approval to proceed with initial trial of ibudilast

MediciNova Inc, a biopharmaceutical company publicly traded on the NASDAQ Global Market and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), today reported FDA's approval to proceed with an initial trial of the company's neurological drug candidate, ibudilast (MN-166/AV411), as a potential new pharmacotherapy for methamphetamine addiction.

27 Sep 2010

Emisphere’s SNAC drug successful in reducing food intake; increasing satiety

Emisphere Technologies, Inc. today announced that a clinical study found that the company's proprietary oral SNAC (Sodium N-[8-(2-hydroxybenzoyl) Amino] Caprylate ("SNAC") additive, in combination with two digestive hormones, was successful in reducing food intake and increasing satiety in healthy male subjects.

18 Sep 2010

TransPharma Medical completes ViaDerm-GLP1 agonist Phase 1a trial for type II diabetes

TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today the successful completion of a Phase 1a trial of ViaDerm-GLP1 agonist which is being developed for the treatment of diabetes mellitus type II.

14 Sep 2010