Efficacy News and Research

RSS

Almirall seeks European approval for linaclotide to treat irritable bowel syndrome with constipation

Almirall, S.A. announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for linaclotide, an investigational guanylate cyclase-C (GC-C) receptor agonist for the treatment of irritable bowel syndrome with constipation (IBS-C). Once approved, linaclotide will be marketed in Europe under the trademark Constella®.

29 Sep 2011

Appalachia pediatricians less likely to encourage HPV vaccination than other area doctors

Pediatricians in Appalachia are less likely than doctors in other areas to encourage parents to have their children receive the human papillomavirus (HPV) vaccine, according to a new study.

29 Sep 2011

Positive new data from Otonomy's OTO-104 Phase 1b study on Meniere's disease

Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that researchers presented positive new data from a Phase 1b study of the company's lead product candidate, OTO-104, in patients with Meniere's disease.

29 Sep 2011

WSJ: Federal judge advances medical records case

The lawsuit, brought by the newspaper's publisher, seeks to overturn an injunction that keeps the public from being able to see Medicare billing records. In related news, The Fiscal Times examines Medicare waste and improper payments.

29 Sep 2011

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

Ironwood Pharmaceuticals, Inc. today announced that its European partner Almirall, S.A. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation.

29 Sep 2011

VOICE HIV prevention trial to discontinue use of tenofovir tablets

VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women - daily use of one of two different ARV tablets or of a vaginal gel - will be dropping one of the oral tablets from the study.

29 Sep 2011

JIA program effective in changing unhealthy youth behaviors

The National Survey of Children's Health indicates 31 percent of Missouri children are overweight or obese; yet, the state lacks physical activity requirements for students and nutritional standards for school meals beyond those recommended by the USDA.

29 Sep 2011

Study links pain severity with depression

A new study in The Journal of Pain, published by the American Pain Society, www.ampainsoc.org, shows that changes in pain severity can predict subsequent depression severity and, likewise, a worsening change in depression is an equally strong predictor of subsequent pain severity.

29 Sep 2011

Enrollment complete in Rexahn's Archexin Phase II trial for metastatic pancreatic cancer

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has completed enrollment for its Phase II clinical trial of Archexin in metastatic pancreatic cancer.

29 Sep 2011

SanBio initiates SB623 Phase 1/2a clinical trial in ischemic stroke

SanBio, Inc. has announced that a patient at Stanford University Medical Center has become the first to be treated with SB623, a novel cell therapy for patients with disability resulting from ischemic stroke.

29 Sep 2011

More of saw palmetto does not reduce urinary symptoms related to BPH

Men with urinary problems related to an enlarged prostate who received increasing doses of the fruit extract saw palmetto did not experience a reduction in these symptoms compared to men who received placebo, according to a study in the September 28 issue of JAMA.

28 Sep 2011

YM BioSciences begins enrollment in CYT387 Phase II trial for myelofibrosis

YM BioSciences Inc. today announced that it has enrolled the first patients in its multi-center Phase II trial of CYT387 administered twice-daily (BID) for the treatment of myelofibrosis.

28 Sep 2011

Americans cutting back on health spending by skipping prescriptions, procedures

A Consumer Reports survey revealed that more Americans are ignoring their doctor’s advice and skipping prescription drugs or medical procedures to save money in 2011 than a year earlier.

28 Sep 2011

Lovastatin appears to be safe, effective for children with neurofibromatosis type 1

Researchers at Children's National Medical Center have found that a cholesterol-lowering statin drug appears to be safe in children with neurofibromatosis type 1 (NF1) and may improve learning disabilities, including verbal and nonverbal memory.

28 Sep 2011

Benefits and harms vary among atypical antipsychotics for off-label use

A review of previous studies suggests that even though atypical antipsychotic medications are commonly used for off-label conditions such as behavioral symptoms of dementia, anxiety, and obsessive-compulsive disorder, these medications are effective for only a few off-label conditions, and that the benefits and harms of these medications for these uses vary, according to an article in the September 28 issue of JAMA.

28 Sep 2011

22nd Century completes enrollment in X-22 Phase II-B smoking cessation study

22nd Century Group, Inc., a company focused on smoking cessation and tobacco harm reduction products, announced today that enrollment of its X-22 Phase II-B clinical trial has been successfully completed; 234 smokers have been randomized in the double-blind, active-controlled, multi-center smoking cessation study.

27 Sep 2011

Arena, Eisai announce new data from lorcaserin Phase 3 clinical trial program

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that new data analyses from the lorcaserin Phase 3 clinical trial program will be presented in poster sessions at Obesity 2011, the 29th Annual Scientific Meeting of The Obesity Society in Orlando, Florida.

27 Sep 2011

Elevation presents positive data from EP-101 Phase 2a study on COPD at ERS annual meeting

Elevation Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, announced today that it presented positive results from a Phase 2a study of EP-101 in patients with moderate to severe chronic obstructive pulmonary disease (COPD), a large and growing disease characterized by significant unmet clinical needs, at the annual meeting of the European Respiratory Society.

27 Sep 2011

Collegium completes Type A meeting with FDA for COL-003 Phase III chronic low back pain study

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, announced today that it has successfully completed a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the proposed Phase III clinical study for COL-003, the Company's tamper-resistant, extended release oxycodone product utilizing its proprietary DETERx technology.

27 Sep 2011

Pacira announces data from EXPAREL clinical study presented at ASPS 2011 meeting

Pacira Pharmaceuticals, Inc. today announced that the company's lead investigational product for postsurgical pain management, EXPAREL, was highlighted in the "Hot Topics in Plastic Surgery" panel at the annual scientific assembly of the American Society of Plastic Surgeons (ASPS) in Denver, Colo.

26 Sep 2011