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MOVANTIK tablets get FDA approval for treatment of OIC in patients with chronic, non-cancer pain

MOVANTIK tablets get FDA approval for treatment of OIC in patients with chronic, non-cancer pain

Nektar Therapeutics reported today that partner AstraZeneca today announced that the US Food and Drug Administration (FDA) approved MOVANTIK (naloxegol) tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. [More]
FDA grants Breakthrough Therapy designation to EYLEA Injection for treatment of diabetic retinopathy

FDA grants Breakthrough Therapy designation to EYLEA Injection for treatment of diabetic retinopathy

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has granted EYLEA (aflibercept) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). [More]
Bayer, Orion begin patient enrollment in ODM-201 Phase III trial for castration-resistant prostate cancer

Bayer, Orion begin patient enrollment in ODM-201 Phase III trial for castration-resistant prostate cancer

Bayer HealthCare and Orion Corporation, a pharmaceutical company based in Espoo, Finland, have begun to enroll patients in a Phase III trial with ODM-201, an investigational oral androgen receptor inhibitor in clinical development. [More]
Amgen announces phase 3 ivabradine data for treatment of chronic HF

Amgen announces phase 3 ivabradine data for treatment of chronic HF

Amgen (NASDAQ: AMGN) today announced data from the Phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study evaluating ivabradine in patients with chronic heart failure (HF) were presented at the 18th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Las Vegas. [More]
Ramucirumab Phase III study meets primary endpoint in patients with metastatic colorectal cancer

Ramucirumab Phase III study meets primary endpoint in patients with metastatic colorectal cancer

Eli Lilly and Company today announced that the RAISE trial, a Phase III study of ramucirumab (CYRAMZA) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival. [More]
FDA approves Contrave extended-release tablets for chronic weight management

FDA approves Contrave extended-release tablets for chronic weight management

Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. jointly announced today that the U.S. Food and Drug Administration has approved Contrave® extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. [More]
AbbVie’s Phase 3 pivotal study shows HUMIRA is effective in reducing symptoms in HS

AbbVie’s Phase 3 pivotal study shows HUMIRA is effective in reducing symptoms in HS

AbbVie today announced results from a Phase 3 pivotal study demonstrating that HUMIRA® (adalimumab) is effective in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules. [More]
Discovery reveals promising target for treatment of end-stage heart failure

Discovery reveals promising target for treatment of end-stage heart failure

As a heart fails, losing its ability to squeeze blood through the circulatory system, the body releases a neurohormone that interferes with the heart's best chance to improve contractility, a team of Temple University School of Medicine researchers show in a study published September 9th in the American Heart Association journal, Circulation. [More]
Researchers examine whether new drug offers added benefit for patients with chronic HCV

Researchers examine whether new drug offers added benefit for patients with chronic HCV

The drug simeprevir has been available since May 2014 for the treatment of adult patients with chronic hepatitis C infection. [More]
New data from Boehringer's Phase III trial program evaluates efficacy of tiotropium in asthma patients

New data from Boehringer's Phase III trial program evaluates efficacy of tiotropium in asthma patients

Boehringer Ingelheim today presented new data from the company's Phase III trial program (UniTinA-asthma®) evaluating tiotropium in asthma, including the first study assessing the efficacy and safety of tiotropium in adolescent patients with symptomatic asthma. [More]
FDA approves Epaned for treatment of symptomatic and asymptomatic heart failure

FDA approves Epaned for treatment of symptomatic and asymptomatic heart failure

Silvergate Pharmaceuticals, Inc., focused on the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration approved Epaned for the treatment of symptomatic heart failure and the treatment of asymptomatic left ventricular dysfunction (to decrease the rate of development of overt heart failure and to reduce hospitalization for heart failure). [More]
Soligenix acquires novel orphan drug candidate for treatment of CTCL

Soligenix acquires novel orphan drug candidate for treatment of CTCL

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today the acquisition of a novel orphan drug candidate, known as SGX301 (synthetic hypericin). [More]
Peramivir drug safe, effective at alleviating influenza symptoms

Peramivir drug safe, effective at alleviating influenza symptoms

An analysis of phase 2 and phase 3 clinical trials shows that a single injected dose of the neuraminidase inhibitor (NAI) peramivir is safe and effective at alleviating influenza symptoms, including fever and viral shedding, when administered within 48 hours of the onset of symptoms. [More]
Current issue provides critical review of data concerned with antidepressant drugs

Current issue provides critical review of data concerned with antidepressant drugs

A paper in the current issue of Psychotherapy and Psychosomatics by Giovanni Fava, MD (University of Bologna) provides a critical review of the data concerned with antidepressant drugs. [More]
White pill may help scientists learn why patients with cystic fibrosis have less exercise capacity

White pill may help scientists learn why patients with cystic fibrosis have less exercise capacity

A little white pill may help scientists learn why patients with cystic fibrosis have less exercise capacity than their peers, even if their lungs are relatively healthy. [More]
XBiotech reports interim results from Phase III study for anti-cancer agent Xilonix

XBiotech reports interim results from Phase III study for anti-cancer agent Xilonix

XBiotech announced today interim results from its fast-tracked Phase III study being conducted in the US for its anti-cancer agent Xilonix. [More]
MEI Pharma completes patient enrollment in Pracinostat Phase II trial for treatment of MDS

MEI Pharma completes patient enrollment in Pracinostat Phase II trial for treatment of MDS

MEI Pharma, Inc., an oncology company focused on the clinical development of novel therapies for cancer, announced today that it has completed enrollment in a randomized Phase II clinical trial of its lead investigational drug candidate Pracinostat in combination with azacitidine in patients with previously untreated intermediate-2 or high-risk myelodysplastic syndrome (MDS). [More]
VentiRx's motolimod receives FDA Fast Track designation for ovarian cancer treatment

VentiRx's motolimod receives FDA Fast Track designation for ovarian cancer treatment

VentiRx Pharmaceuticals, Inc., a clinical stage biopharmaceutical company committed to the development and commercialization of novel Toll-like receptor 8 (TLR8) immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy. [More]
Ambulance administration of antiplatelet medication may help heart attack patients

Ambulance administration of antiplatelet medication may help heart attack patients

Ambulance administration of the antiplatelet medication ticagrelor to patients with a type of heart attack known as ST segment elevation myocardial infarction (STEMI) is not better than hospital administration, in terms of improving blood flow in blocked arteries before a revascularisation procedure, according to a new study presented at ESC Congress 2014 today. [More]
Experimental agent TRO40303 ineffective in patients with heart attack

Experimental agent TRO40303 ineffective in patients with heart attack

The administration of an experimental agent known as TRO40303 to patients who have had a heart attack, with the hope of preventing tissue damage when impaired blood flow is corrected (reperfusion), was disappointingly ineffective according to results of a European study of patients with acute ST-elevation myocardial infarction (STEMI) presented today as a Hot Line the ESC Congress 2014 with simultaneous publication in the European Heart Journal. [More]