Placebo News and Research

RSS

Enrollment complete in Ocera Therapeutics' ASTUTE Phase 2B trial for mild hepatic encephalopathy

Ocera Therapeutics, Inc. announced today that the ASTUTE Study (AST-120 Used to Treat Hepatic Encephalopathy) has completed enrollment for its Phase 2B study ahead of schedule, with data expected mid 2010.

24 Feb 2010

Forest Laboratories' Bystolic tablets for treatment of stable CHF failed to receive FDA approval

Forest Laboratories, Inc. announced today that the U.S. Food and Drug Administration did not approve the additional indication for Bystolic® (nebivolol) tablets as a treatment for stable chronic heart failure (CHF) as requested in the company’s Supplemental New Drug Application (sNDA).

23 Feb 2010

FDA Gastrointestinal Drugs Advisory Committee supports approval of XIFAXAN 550 mg for management of HE

Salix Pharmaceuticals, Ltd. today reported that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).

23 Feb 2010

Aradigm initiates dosing in Phase 2b trial of inhaled liposomal ciprofloxacin formulations in BE patients

Aradigm Corporation today announced that it dosed the first patient in the U.S. as part of its ORBIT-1 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial, an international, randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin (ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE) under a U.S. IND. This orphan disease indication is a chronic, severe respiratory disease and there are currently no approved treatments for this disease in the U.S.

23 Feb 2010

Lexicon Pharmaceuticals reports positive results from Phase 2 clinical trials for IBS and type 2 diabetes

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three months and year ended December 31, 2009.

23 Feb 2010

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston® (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

23 Feb 2010

Obecure granted patent covering betahistine with olanzapine for mitigating antipsychotic drug associated weight gain

Obecure Ltd., a subsidiary of Bio-Light Israeli Life Science Investments Ltd., has received notice of allowance from the US Patent Office for its two key patent applications covering methods of use and compositions covering the use of betahistine with olanzapine for the mitigation of the serious weight gain associated as a side effect of the antipsychotic drug.

23 Feb 2010

More research needed for osteoporosis treatments

Dr. Angelo Malamis says that 90 percent of his patients who have undergone a treatment called balloon kyphoplasty for vertebral fractures report significant reductions in pain and disability.

23 Feb 2010

Amylin Pharmaceuticals and Takeda Pharmaceutical to advance pramlintide/metreleptin combination therapy development

Amylin Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited announced today that the companies have selected the combination treatment of pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin, for advancement toward Phase 3 development. The decision to advance the program followed encouraging results from a 52-week blinded, placebo-controlled Phase 2 extension study. The pramlintide/metreleptin combination met the key target criteria of sustained and robust weight loss.

23 Feb 2010

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

BioSante Pharmaceuticals, Inc., today announced additional positive safety data in its ongoing LibiGel Phase III clinical development program. For the second time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review, the DMC once again unanimously recommended continuation of the study as described in the FDA-agreed LibiGel safety study protocol, with no modifications.

22 Feb 2010

Boehringer Ingelheim Pharmaceuticals receives FDA approval for Mirapex ER in treatment of early PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex ER® (pramipexole dihydrochloride) extended-release tablets, a new once-daily treatment option for the signs and symptoms of early idiopathic Parkinson's disease (PD). MIRAPEX ER is not indicated in advanced PD. Parkinson's disease is a chronic, slowly progressive and potentially debilitating neurological condition affecting nearly one million people in the U.S., with one person newly diagnosed every nine minutes.

22 Feb 2010

Alnylam Pharmaceuticals initiates ALN-RSV01 Phase IIb trial in adult lung transplant patients for RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has initiated a Phase IIb trial in adult lung transplant patients with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection. RSV infection in lung transplant patients represents an important unmet medical need; the condition is associated with significant morbidity, including the development of acute lung transplant rejection in 10% to 20% of infected patients.

22 Feb 2010

Data from Novavax's Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study presented at WHO meeting

Novavax, Inc. today presented to the world's leading pandemic influenza vaccine experts a summary of the recent preliminary safety and immunogenicity data from its Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study in Mexico.

19 Feb 2010

Lower dose of avosentan drug may provide more favorable results in diabetes patients

The drug avosentan substantially reduces urinary protein loss in people with type 2 diabetes and kidney disease, but the drug causes serious side effects, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN).

18 Feb 2010

Incyte announces 2009 financial results and key fourth-quarter accomplishments

Incyte Corporation today reported fourth quarter and full year 2009 financial results, provided an update on key fourth quarter accomplishments and 2010 objectives, and announced its 2010 financial guidance.

18 Feb 2010

GSK Consumer Healthcare applauds two smoking cessation organizations for improving smoking cessation aids

GlaxoSmithKline Consumer Healthcare, marketer of nicotine replacement therapy (NRT) products, including Nicorette®, NicoDerm® CQ® and Commit®, applauds two leading smoking cessation organizations for their efforts to improve the regulation of smoking cessation aids designed to help people quit smoking.

18 Feb 2010

Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has received an FDA PDUFA date of October 3, 2010. This NDA review is in support of US marketing approval and registration of Dyloject for the management of acute moderate-to-severe pain in adults.

18 Feb 2010

Tioga Pharmaceuticals to utilize $18M equity funding for Phase 3 clinical trial of asimadoline

Tioga Pharmaceuticals, Inc. today announced the closing of an $18 million equity financing. Current investors Forward Ventures, New Leaf Venture Partners and BB Biotech Ventures were joined by new investor Genesys Capital Partners.

17 Feb 2010

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Otonomy, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of OTO-104 in patients with Meniere's disease, a debilitating disorder of the inner ear affecting balance and hearing.

17 Feb 2010

Phase III study: GARDASIL prevents 77.5% of pre-cursor lesions to anal cancer

In a new phase III study, GARDASIL(R) (Quadrivalent Human Papillomavirus (Types 6, 11, 16 and 18) Recombinant Vaccine) prevented 77.5 per cent of anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men.

17 Feb 2010

Placebo News and Research

Enrollment complete in Ocera Therapeutics' ASTUTE Phase 2B trial for mild hepatic encephalopathy

Forest Laboratories' Bystolic tablets for treatment of stable CHF failed to receive FDA approval

FDA Gastrointestinal Drugs Advisory Committee supports approval of XIFAXAN 550 mg for management of HE

Aradigm initiates dosing in Phase 2b trial of inhaled liposomal ciprofloxacin formulations in BE patients

Lexicon Pharmaceuticals reports positive results from Phase 2 clinical trials for IBS and type 2 diabetes

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Obecure granted patent covering betahistine with olanzapine for mitigating antipsychotic drug associated weight gain

More research needed for osteoporosis treatments

Amylin Pharmaceuticals and Takeda Pharmaceutical to advance pramlintide/metreleptin combination therapy development

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

Boehringer Ingelheim Pharmaceuticals receives FDA approval for Mirapex ER in treatment of early PD

Alnylam Pharmaceuticals initiates ALN-RSV01 Phase IIb trial in adult lung transplant patients for RSV infection

Data from Novavax's Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study presented at WHO meeting

Lower dose of avosentan drug may provide more favorable results in diabetes patients

Incyte announces 2009 financial results and key fourth-quarter accomplishments

GSK Consumer Healthcare applauds two smoking cessation organizations for improving smoking cessation aids

Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Tioga Pharmaceuticals to utilize $18M equity funding for Phase 3 clinical trial of asimadoline

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Phase III study: GARDASIL prevents 77.5% of pre-cursor lesions to anal cancer

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

Latest News