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Actavis receives complete response letter for nebivolol/valsartan FDC for treatment of hypertension

Actavis plc today confirmed that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for the fixed-dose combination (FDC) of nebivolol and valsartan for the treatment of hypertension.

25 Dec 2014

FDA approves Namzaric drug for treatment of moderate to severe Alzheimer's disease

Actavis plc and Adamas Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor.

25 Dec 2014

EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

Synageva BioPharma Corp., a biopharmaceutical company developing therapeutic products for rare disorders, today announced validation by the European Medicines Agency of the Marketing Authorization Application for sebelipase alfa for LAL Deficiency.

23 Dec 2014

First successful vaccination of deer against chronic wasting disease

Researchers at NYU Langone Medical Center and elsewhere say that a vaccination they have developed to fight a brain-based, wasting syndrome among deer and other animals may hold promise on two additional fronts: Protecting U.S. livestock from contracting the disease, and preventing similar brain infections in humans.

23 Dec 2014

Experimental Ebola vaccine safe and immunogenic in African population

Two experimental DNA vaccines to prevent Ebola virus and the closely related Marburg virus [1] are safe, and generated a similar immune response in healthy Ugandan adults as reported in healthy US adults earlier this year.

23 Dec 2014

Can-Fite BioPharma begins dosing in CF102 Phase II liver cancer trial

Can-Fite BioPharma Ltd., a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today announced that it has dosed the first patient in a Phase II trial for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.

22 Dec 2014

Prostaglandin analogue eye drops reduce risk of vision loss in OAG patients

Prostaglandin analogue eye drops, the most commonly prescribed treatment for glaucoma, can greatly reduce risk of vision loss in people with open angle glaucoma (OAG), one of the leading causes of blindness, according to the first placebo-controlled trial to assess their vision-preserving effect published in The Lancet.

22 Dec 2014

FDA approves AbbVie's VIEKIRA PAK for treatment of patients with GT1 HCV infection

The U.S. Food and Drug Administration has approved AbbVie's VIEKIRA PAK, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis.

21 Dec 2014

Oral budesonide suspension offers hope for pediatric patients with EoE

A new formulation of oral budesonide suspension, a steroid-based treatment, is safe and effective in treating pediatric patients with eosinophilic esophagitis (EoE), according to a new study in Clinical Gastroenterology and Hepatology, the official clinical practice journal of the American Gastroenterological Association.

19 Dec 2014

Ipsen's Somatuline Depot Injection 120 mg receives FDA approval for treatment of GEP-NETs

Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen, today announced that Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) was approved by the U.S. Food and Drug Administration for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival (PFS).

19 Dec 2014

$Nuvo Research completes WF10 Phase 2 trial in patients with refractory allergic rhinitis$

Nuvo Research completes WF10 Phase 2 trial in patients with refractory allergic rhinitis

Nuvo Research Inc., a specialty pharmaceutical company with a diverse portfolio of immunology and topical products, today announced that 179 patients have completed its 16-week, double-blind, placebo-controlled, Phase 2 clinical trial to investigate the safety and efficacy of WF10 in patients with refractory allergic rhinitis.

18 Dec 2014

EC grants orphan drug designation to TxCell's Col-Treg for treatment of autoimmune uveitis

TxCell SA, a biotechnology company developing innovative, cost-effective, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that the European Commission (EC) has granted orphan drug designation to TxCell's investigational medicinal product Col-Treg, a personalized T cell immunotherapy using collagen-II specific regulatory T-cells, for the treatment of autoimmune uveitis.

18 Dec 2014

UK doctors to test cannabis-based medicine for children with severe epilepsy

Children with severe epilepsy could be helped by a new treatment derived from the cannabis plant.

18 Dec 2014

Emerging evidence suggests electronic cigarettes can help smokers quit

New Cochrane review finds emerging evidence that smokers who use electronic cigarettes can stop or reduce their smoking.

17 Dec 2014

Lilly receives FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its third U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab).

16 Dec 2014

Isis Pharmaceuticals begins ISIS-DMPK Rx clinical study in DM1 patients

Isis Pharmaceuticals, Inc. announced today that it has initiated a study for ISIS-DMPK Rx in patients with Myotonic Dystrophy Type 1 (DM1). DM1 is a rare genetic neuromuscular disease caused by the production of toxic dystrophia myotonica-protein kinase (DMPK) RNA in cells. ISIS-DMPKRx is specifically designed to reduce toxic DMPK RNA.

16 Dec 2014

Crealta publishes review of post-hoc safety analysis completed for Krystexxa

Crealta Pharmaceuticals LLC, today announced that the Journal of Clinical Rheumatology published a comprehensive review of a post-hoc safety analysis that was completed for Krystexxa (pegloticase), including data from the two pivotal randomized Phase III trials and one open-label extension trial.

14 Dec 2014

Preventive effect of tamoxifen drug for breast cancer remains virtually constant for 20 years

The preventive effect of breast cancer drug 'tamoxifen' remains virtually constant for at least 20 years - with rates reduced by around 30 per cent - new analysis published in The Lancet Oncology reveals.

12 Dec 2014

Progesterone treatment shows no clinical benefits in severe TBI patients

A study concluded that after five days of treatment with a novel formulation of progesterone acutely administered to patients with severe traumatic brain injury (TBI), showed no clinical benefits.

11 Dec 2014

Alizé Pharma completes two Phase I clinical trials of AZP-531 in healthy volunteers, obese subjects

Alizé Pharma SAS, an Alizé Pharma group company specialized in the development of biopharmaceuticals to treat metabolic disorders and rare diseases, announces today the completion of two Phase I clinical trials with its unacylated ghrelin analog AZP-531 in 76 healthy volunteers and overweight or obese subjects.

10 Dec 2014

Placebo News and Research

Actavis receives complete response letter for nebivolol/valsartan FDC for treatment of hypertension

FDA approves Namzaric drug for treatment of moderate to severe Alzheimer's disease

EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

First successful vaccination of deer against chronic wasting disease

Experimental Ebola vaccine safe and immunogenic in African population

Can-Fite BioPharma begins dosing in CF102 Phase II liver cancer trial

Prostaglandin analogue eye drops reduce risk of vision loss in OAG patients

FDA approves AbbVie's VIEKIRA PAK for treatment of patients with GT1 HCV infection

Oral budesonide suspension offers hope for pediatric patients with EoE

Ipsen's Somatuline Depot Injection 120 mg receives FDA approval for treatment of GEP-NETs

Nuvo Research completes WF10 Phase 2 trial in patients with refractory allergic rhinitis

EC grants orphan drug designation to TxCell's Col-Treg for treatment of autoimmune uveitis

UK doctors to test cannabis-based medicine for children with severe epilepsy

Emerging evidence suggests electronic cigarettes can help smokers quit

Lilly receives FDA approval for CYRAMZA (ramucirumab)

Isis Pharmaceuticals begins ISIS-DMPK Rx clinical study in DM1 patients

Crealta publishes review of post-hoc safety analysis completed for Krystexxa

Preventive effect of tamoxifen drug for breast cancer remains virtually constant for 20 years

Progesterone treatment shows no clinical benefits in severe TBI patients

Alizé Pharma completes two Phase I clinical trials of AZP-531 in healthy volunteers, obese subjects

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