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Vraylar (cariprazine) capsules now approved by FDA to treat schizophrenia, bipolar disorder in adults

The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.

9 Oct 2015

Brain & Behavior Research Foundation to honor nine scientists with Outstanding Achievement Prizes

The Brain & Behavior Research Foundation will honor nine scientists with its 2015 Outstanding Achievement Prizes for their work in schizophrenia, mood disorders, child and adolescent psychiatry, and cognitive neuroscience.

9 Oct 2015

Repatha (evolocumab) injection gets FDA approval for high cholesterol

The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.

9 Oct 2015

Manchester researchers demonstrate safety, effectiveness of eltrombopag treatment in children with ITP

Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.

9 Oct 2015

Research on investigational menopause drug wins first prize

Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of emerging late-stage women’s health products, today announced it received top honors for its research on investigational drug lasofoxifene at the 26th annual North American Menopause Society (NAMS) meeting in Las Vegas last week.

9 Oct 2015

Celtaxsys commences acebilustat phase 2 trial in patients with cystic fibrosis in US

Celtaxsys, a clinical stage drug development company focused on advancing care for patients suffering from orphan inflammatory diseases, announced today the commencement of the US arm of an international phase 2 clinical trial for its flagship compound, acebilustat, in patients with cystic fibrosis (CF).

8 Oct 2015

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Mallinckrodt plc, a leading specialty biopharmaceutical company, today announced that data from a pilot study for its H.P. Acthar Gel (repository corticotropin injection) will be presented at the American College of Rheumatology 2015 Annual Meeting to be held November 7-11 in San Francisco.

8 Oct 2015

Neurocrine Biosciences announces positive data from NBI-98854 Phase III trial in tardive dyskinesia

Neurocrine Biosciences, Inc. announced today that NBI-98854, a highly selective small molecule VMAT2 inhibitor, showed a statistically significant reduction in tardive dyskinesia during the six weeks of placebo-controlled treatment in the Kinect 3 clinical trial. This Phase III trial included moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder.

8 Oct 2015

Smoking cessation medication 46% effective in women

The most effective prescription drug used to quit smoking initially helps women more than men, according to a Yale School of Medicine study. The study, published Oct. 7 by the journal Nicotine and Tobacco Research, found that varenicline, marketed as Chantix, was more effective earlier in women, and equally effective in women and men after one year.

8 Oct 2015

Genocea announces positive data in Phase 2 trial evaluating GEN-003 for the treatment of genital herpes

Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, has announced positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p < 0.0001), the primary endpoint of the study.

7 Oct 2015

Interim data from long-term extension Tecfidera® (dimethyl fumarate) study

Biogen (NASDAQ: BIIB) will, this week, present data at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, demonstrating the efficacy and safety of TECFIDERA® (dimethyl fumarate) across a broad range of people with relapsing-remitting multiple sclerosis (RRMS).

7 Oct 2015

Everolimus, 177Lu-dotatate extend neuroendocrine tumour PFS

Positive progression-free survival results from the RADIANT-4 and NETTER-1 trials extend the armamentarium for physicians treating patients with neuroendocrine tumours.

7 Oct 2015

OLFUS study supports safety, efficacy of DBV's Viaskin Peanut patch in children with peanut allergy

DBV Technologies, a clinical-stage specialty biopharmaceutical company, today announced that topline findings from the first 12 months of the OLFUS-VIPES study, or OLFUS, support the long-term safety and efficacy of Viaskin Peanut for the treatment of peanut allergy.

7 Oct 2015

Researchers explore how common genetic mutation influences effects of taking melatonin close to mealtime

Researchers from Brigham and Women's Hospital and the University of Murcia, Spain, have shed new light on why people who carry a common genetic mutation may be more at risk for developing type 2 diabetes. By carefully studying healthy subjects, researchers were able to chart the effect of melatonin supplements on blood sugar control.

7 Oct 2015

Tarix Orphan's TXA127 granted FDA Fast Track Designation for treatment of DMD patients

Tarix Orphan LLC, a privately held biopharmaceutical company focused on the treatment of rare neuromuscular disorders and connective tissue diseases, today announced that the U.S. Food and Drug Administration has granted Fast Track Designation to TXA127 (angiotensin 1-7) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients.

6 Oct 2015

First patients screened in Axovant's phase 3 study of RVT-101

Axovant Sciences Ltd., a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced the first patients screened in MINDSET, a confirmatory global phase 3 study of Axovant's lead product candidate, RVT-101. Axovant also announced that the company and the U.S. Food and Drug Administration have agreed to a Special Protocol Assessment (SPA) supporting this phase 3 program.

6 Oct 2015

Nivolumab, ipilimumab duo effective in poor prognosis advanced melanoma patients

Subgroups of advanced melanoma patients with a poor prognosis derive a progression-free survival benefit from the combination of nivolumab and ipilimumab, according to research presented at the European Cancer Congress in Vienna, Austria.

5 Oct 2015

Clinical data from spinal muscular atrophy program presented at 20th International WMS Congress

PTC Therapeutics, Inc., today announced that clinical data from the company's joint development program with Roche and the SMA Foundation in spinal muscular atrophy (SMA) were presented at the 20th International Congress of the World Muscle Society (WMS) in Brighton, U.K.

5 Oct 2015

Calcitonin-gene related peptide antibody inhibition shows migraine prevention promise

TEV-48125, a monoclonal anti-calcitonin-gene related peptide antibody, is well tolerated and effective in the prevention of high-frequency episodic migraine and chronic migraine, findings from two phase IIb studies show.

2 Oct 2015

6-minute walk ‘not an accurate surrogate’ in systemic sclerosis-associated PAH

The 6-minute walk distance of patients with systemic sclerosis-associated pulmonary arterial hypertension is not a suitable marker for tracking treatment-related haemodynamic changes, say researchers.

2 Oct 2015

Placebo News and Research

Vraylar (cariprazine) capsules now approved by FDA to treat schizophrenia, bipolar disorder in adults

Brain & Behavior Research Foundation to honor nine scientists with Outstanding Achievement Prizes

Repatha (evolocumab) injection gets FDA approval for high cholesterol

Manchester researchers demonstrate safety, effectiveness of eltrombopag treatment in children with ITP

Research on investigational menopause drug wins first prize

Celtaxsys commences acebilustat phase 2 trial in patients with cystic fibrosis in US

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Neurocrine Biosciences announces positive data from NBI-98854 Phase III trial in tardive dyskinesia

Smoking cessation medication 46% effective in women

Genocea announces positive data in Phase 2 trial evaluating GEN-003 for the treatment of genital herpes

Interim data from long-term extension Tecfidera® (dimethyl fumarate) study

Everolimus, 177Lu-dotatate extend neuroendocrine tumour PFS

OLFUS study supports safety, efficacy of DBV's Viaskin Peanut patch in children with peanut allergy

Researchers explore how common genetic mutation influences effects of taking melatonin close to mealtime

Tarix Orphan's TXA127 granted FDA Fast Track Designation for treatment of DMD patients

First patients screened in Axovant's phase 3 study of RVT-101

Nivolumab, ipilimumab duo effective in poor prognosis advanced melanoma patients

Clinical data from spinal muscular atrophy program presented at 20th International WMS Congress

Calcitonin-gene related peptide antibody inhibition shows migraine prevention promise

6-minute walk ‘not an accurate surrogate’ in systemic sclerosis-associated PAH

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