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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

Oral tenofovir discontinued in HIV clinical trial

A large-scale clinical trial evaluating whether daily use of an oral tablet or vaginal gel containing antiretroviral drugs can prevent HIV infection in women is being modified because an interim review found that the study cannot show that one of the study products, oral tenofovir, marketed under the trade name Viread, is effective.

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

Cincinnati Children's to conduct first pediatric migraine medicine clinical trial

Cincinnati Children's Hospital Medical Center has received a $12 million grant from the National Institutes of Health to conduct the first clinical trial to determine the medication of choice for preventing migraines in children and teens.

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

Valeant's colesevelam New Drug Submission for hypercholesterolemia receives Canadian approval

Valeant Pharmaceuticals International, Inc. announced that its wholly owned subsidiary, Valeant International (Barbados) SRL, has received notice that the New Drug Submission for colesevelam hydrochloride (colesevelam), an oral bile acid sequestrant for hypercholesterolemia, has been approved by the Canadian regulatory authority Health Canada.

28 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

Phase I clinical trials reveal MVA-B preventive vaccine's immune efficiency against HIV

Phase I clinical trials developed by Spanish Superior Scientific Research Council (CSIC) together with Gregorio Mara--n Hospital in Madrid and Cl-nic Hospital in Barcelona, reveals MVA-B preventive vaccine's immune efficiency against Human's immunodeficiency virus (HIV).

28 Sep 2011

Adamas begins ADS-5102 Phase 2/3 clinical trial in Parkinson's disease

Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has initiated a Phase 2/3 clinical trial of its proprietary investigational drug ADS-5102 (amantadine HCl extended release) for the treatment of levodopa induced dyskinesia (LID) in patients with Parkinson's disease.

28 Sep 2011

Saw Palmetto ineffective in patients with enlarged prostate: Study

A new study showed that much cited saw-palmetto supplements for the middle aged to cope with the symptoms of an enlarged prostate might not do much at all.

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

Asians struggling with alcoholism may benefit from naltrexone

New UCLA psychology research indicates that Asians who are struggling with alcoholism may benefit especially from naltrexone, one of three medications approved by the U.S. Food and Drug Administration for the treatment of alcoholism.

28 Sep 2011

BioLineRx's BL-1020 Phase IIb EAGLE trial data on schizophrenia to be presented at ECSR

BioLineRx, a biopharmaceutical development company, today announced that data from the successfully completed Phase IIb EAGLE study of BL-1020, a first in class GABA-enhanced antipsychotic for the treatment of schizophrenia, will be presented at the 3rd European Conference on Schizophrenia Research (ECSR) held in Berlin, Germany.

28 Sep 2011

MicroDose initiates MDT-637 Phase 1 trial in respiratory syncytial virus

MicroDose Therapeutx, Inc. today announced that the first human subject has been dosed in a Phase 1 clinical trial of MDT-637, MicroDose's inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus.

28 Sep 2011

HCRI completes enrollment in dual antiplatelet therapy clinical trial

The Harvard Clinical Research Institute (HCRI) announced today that the enrollment phase of the DAPT Study has been successfully completed. The DAPT Study is a four-year clinical trial investigating the duration of dual antiplatelet therapy (DAPT, the combination of aspirin and a thienopyridine/antiplatelet medication to reduce the risk of blood clots) following drug-eluting stent implantations.

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

Novartis files marketing authorisation with EMA for NVA237 to treat COPD

Sosei Group Corporation, today announces that NVA237 (glycopyrronium bromide), a long-acting muscarinic antagonist (LAMA) being investigated as a once-daily treatment for chronic obstructive pulmonary disease (COPD), has been filed by Novartis for marketing authorisation with the European Medicines Agency (EMA), under the brand-name Seebri Breezhaler, triggering a $5m milestone payment to Sosei.

27 Sep 2011

Alnylam commences ALN-PCS Phase I trial in severe hypercholesterolemia

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has initiated dosing in its Phase I clinical trial with ALN-PCS, an RNAi therapeutic targeting proprotein convertase subtilisin/kexin type 9, or PCSK9, for the treatment of severe hypercholesterolemia.

27 Sep 2011