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Janssen receives FDA Priority Review for ZYTIGA sNDA to treat mCRPC

Janssen Research & Development, LLC, announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for ZYTIGA (abiraterone acetate) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.

30 Aug 2012

Protalex announces results from PRTX-100 Phase 1b trial on active rheumatoid arthritis

Protalex, Inc., a clinical stage biopharmaceutical company focused on the development of a class of drugs designed to treat autoimmune and inflammatory diseases including rheumatoid arthritis (RA), today announced results from its recently completed Phase 1b randomized, multiple-dose, dose-escalation study.

30 Aug 2012

Collegium commences enrollment in Oxycodone DETERx Phase 3 study in chronic lower back pain

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain today announced that it has initiated enrollment in its Phase 3 clinical study for Oxycodone DETERx (COL-003).

30 Aug 2012

Sicor Biotech receives FDA approval for tbo-filgrastim to treat severe neutropenia

The U.S. Food and Drug Administration today approved Sicor Biotech's tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.

30 Aug 2012

Elan commences ELND005 Phase 2 study in Bipolar I Disorder

Elan Corporation, plc today announced that it has commenced a Phase 2, placebo-controlled, safety and efficacy study of oral ELND005 as an adjunctive maintenance treatment in patients with Bipolar I Disorder (BPD 1) to delay the time to occurrence of mood episodes.

30 Aug 2012

Novartis receives FDA approval for Afinitor Disperz to treat subependymal giant cell astrocytoma

The U.S. Food and Drug Administration today approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma.

30 Aug 2012

Sleep disorder treatment: an interview with Dr Seth Lederman, President and CEO of Tonix Pharmaceuticals

Sleep disorders are a large area. We are focused on one particular type of sleep disturbance called “non-restorative” sleep. People with this problem do sleep, but they don’t wake up feeling refreshed or feeling that their sleep has had the restorative effects of healthy sleep.

29 Aug 2012

Eplerenone shown to reduce cumulative heart failure hospitalisations

Pfizer Inc. (NYSE: PFE) announced results from a new post-hoc analysis of the EMPHASIS-HF trial showing statistically significant reductions in rates of cumulative heart failure (HF) hospitalisations in patients with HF treated with eplerenone compared with placebo on a background of standard optimal therapy.1 The results were presented at The European Society of Cardiology Congress (ESC) in Munich.

28 Aug 2012

Aeterna Zentaris commences enrollment in AEZS-130 Phase 2A trial for cancer cachexia

Aeterna Zentaris Inc. today announced that a first patient has been recruited for a Phase 2A trial with its ghrelin agonist, AEZS-130 in patients with cancer cachexia.

28 Aug 2012

Positive results from Spinifex’s EMA401 Phase 2 trial on postherpetic neuralgia

Spinifex Pharmaceuticals, an Australian pain drug development company, today announces positive headline results from the Phase 2 clinical trial of its lead product, EMA401, in postherpetic neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

28 Aug 2012

Morphotek commences MORAb-004 Phase II metastatic soft tissue sarcoma trial

Morphotek, Inc. announced today that it has commenced a multi-center, Phase II study evaluating the safety and efficacy of MORAb-004 when combined with gemcitabine and docetaxel in the treatment of metastatic soft tissue sarcoma.

28 Aug 2012

Merz acquires CUVPOSA oral solution to treat children with cerebral palsy

Merz, Inc. today announced the acquisition of CUVPOSA (glycopyrrolate) oral solution for pediatric chronic severe drooling associated with neurologic conditions such as cerebral palsy.

27 Aug 2012

Insulin glargine retards progression of atherosclerosis in high-risk people

A sub-study of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial, designed to investigate the effect of insulin glargine and omega-3 fatty acids on atherosclerosis progression, has found that, compared to standard care, only insulin glargine (a long-acting insulin) had a "modest" statistically non-significant reducing effect on the primary outcome of rate of change in maximum carotid intima media thickness (CIMT) at 12 carotid sites.

27 Aug 2012

Update on Merck's development programs for vorapaxar, ER niacin/laropirprant and anacetrapib

Merck today provided an update on the development programs for vorapaxar, extended release niacin/laropirprant (MK524A, Tredaptive) and anacetrapib in association with the European Society of Cardiology (ESC) meeting in Munich.

27 Aug 2012

Additional data from Auxilium XIAFLEX phase III studies on Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced that additional data will be presented from its IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the phase III studies that assessed XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease (PD).

27 Aug 2012

Spironolactone should be considered as a treatment option in hypertensive patients with DHF

Mineralocorticoid receptor antagonists should be considered as a treatment option in hypertensive patients with diastolic heart failure, said Professor Burkert Pieske presenting results today of the Aldosterone Receptor Blockade in Diastolic Heart Failure (Aldo-DHF) study at ESC Congress 2012.

27 Aug 2012

XJB-5-131 prevents secondary damage of severe traumatic brain injury

Treatment with an agent that blocks the oxidation of an important component of the mitochondrial membrane prevented the secondary damage of severe traumatic brain injury and preserved function that would otherwise have been impaired, according to a research team from the University of Pittsburgh School of Medicine, Graduate School of Public Health and Department of Chemistry in a report published online today in Nature Neuroscience.

27 Aug 2012

Statins reduce pancreatitis risk

Statins reduce the risk for pancreatitis in patients with normal or mildly elevated triglyceride levels, say the authors of a large meta-analysis.

24 Aug 2012

Vandetanib shows efficacy in thyroid cancer

The tyrosine kinase inhibitor vandetanib could significantly extend progression-free survival in patients with locally advanced or metastatic differentiated radioiodine-refractory thyroid cancer, show results of a small phase II randomized trial.

24 Aug 2012

Lilly’s solanezumab Phase 3 trials on AD do not meet primary endpoints

Eli Lilly and Company today announced that the primary endpoints, both cognitive and functional, were not met in either of the two Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION trials in patients with mild-to-moderate Alzheimer's disease.

24 Aug 2012

Placebo News and Research

Janssen receives FDA Priority Review for ZYTIGA sNDA to treat mCRPC

Protalex announces results from PRTX-100 Phase 1b trial on active rheumatoid arthritis

Collegium commences enrollment in Oxycodone DETERx Phase 3 study in chronic lower back pain

Sicor Biotech receives FDA approval for tbo-filgrastim to treat severe neutropenia

Elan commences ELND005 Phase 2 study in Bipolar I Disorder

Novartis receives FDA approval for Afinitor Disperz to treat subependymal giant cell astrocytoma

Sleep disorder treatment: an interview with Dr Seth Lederman, President and CEO of Tonix Pharmaceuticals

Eplerenone shown to reduce cumulative heart failure hospitalisations

Aeterna Zentaris commences enrollment in AEZS-130 Phase 2A trial for cancer cachexia

Positive results from Spinifex’s EMA401 Phase 2 trial on postherpetic neuralgia

Morphotek commences MORAb-004 Phase II metastatic soft tissue sarcoma trial

Merz acquires CUVPOSA oral solution to treat children with cerebral palsy

Insulin glargine retards progression of atherosclerosis in high-risk people

Update on Merck's development programs for vorapaxar, ER niacin/laropirprant and anacetrapib

Additional data from Auxilium XIAFLEX phase III studies on Peyronie's disease

Spironolactone should be considered as a treatment option in hypertensive patients with DHF

XJB-5-131 prevents secondary damage of severe traumatic brain injury

Statins reduce pancreatitis risk

Vandetanib shows efficacy in thyroid cancer

Lilly’s solanezumab Phase 3 trials on AD do not meet primary endpoints

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