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First data from Boehringer Ingelheim’s Respimat Phase III asthma program

Boehringer Ingelheim presented today the first data from the Phase III UniTinA-asthma program. In two studies, presented at the 2012 European Respiratory Society (ERS) Congress in Vienna, Austria, tiotropium delivered once daily via the Respimat inhaler significantly improved lung function and reduced asthma exacerbations in patients who remained symptomatic on current treatment with at least high dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA).

3 Sep 2012

SPIRIVA to mark 10th anniversary with European Respiratory Society Congress

Coinciding with the annual European Respiratory Society Congress, ERS 2012, SPIRIVA (tiotropium), the first once-daily long-acting inhaled anticholinergic maintenance treatment for patients with Chronic Obstructive Pulmonary Disease (COPD) will mark its 10th anniversary since launch.

3 Sep 2012

Positive results from Elevation Pharmaceuticals’ EP-101 Phase 2b study on COPD

Elevation Pharmaceuticals, Inc. today presented positive efficacy and safety results from the GOLDEN-1 study – a Phase 2b study evaluating EP-101 in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) – at the annual meeting of the European Respiratory Society in Vienna, Austria.

3 Sep 2012

Sophiris announces data from PRX302 transrectal safety study on Benign Prostatic Hyperplasia

Sophiris Bio Inc. today announced data from its transrectal safety study, in which PRX302, the company's drug candidate for the treatment of Benign Prostatic Hyperplasia (BPH or enlarged prostate), was well tolerated through three months following a transrectal injection.

1 Sep 2012

Astellas Pharma receives FDA approval for Xtandi to treat metastatic CRPC

The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.

1 Sep 2012

Study reports flaws in design, analysis, and interpretation of Lyme disease

Most doctors treat Lyme disease with antibiotics for two to four weeks after diagnosis, but if symptoms persist after that, medical guidelines recommend against antibiotic retreatment. That recommendation may not be warranted. A newly published statistical review of the four studies upon which those guidelines are based reports flaws in design, analysis, and interpretation that call into question the strength of the evidence against retreatment.

31 Aug 2012

Promising results with SLIT for childhood grass pollen allergy

High-dose sublingual immunotherapy effectively reduces allergic symptoms and medication use in children with grass pollen–allergic rhinoconjunctivitis, show study results.

31 Aug 2012

Janssen submits bedaquiline MAA with EMA for treatment of multi-drug resistant tuberculosis

Janssen-Cilag International NV (Janssen) today announced it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval for the use of the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults.

31 Aug 2012

Elan commences ELND005 Phase 2 study in Bipolar I Disorder

Transition Therapeutics Inc. today announced that its licensing partner, Elan Corporation, plc 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.

31 Aug 2012

FDA approves Ironwood’s LINZESS to treat irritable bowel syndrome with constipation

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. announced today that LINZESS (linaclotide) was approved by the U.S. Food and Drug Administration (FDA) as a once-daily treatment for adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).

31 Aug 2012

Bayer submits regorafenib NDA with FDA for treatment of metastatic and/or unresectable GIST

Bayer HealthCare and Onyx Pharmaceuticals today announced that Bayer HealthCare has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment.

31 Aug 2012

Ironwood receives FDA approval for Linzess to treat chronic idiopathic constipation, IBS

The U.S. Food and Drug Administration today approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults.

31 Aug 2012

Sosei’s QVA149 Phase III study on COPD meets primary endpoint

Sosei Group Corporation confirms the information released today by Novartis that results from the fifth QVA149 (indacaterol maleate / glycopyrronium bromide) Phase III study, SPARK, met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared to glycopyrronium bromide.

31 Aug 2012

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

Placebo News and Research

First data from Boehringer Ingelheim’s Respimat Phase III asthma program

SPIRIVA to mark 10th anniversary with European Respiratory Society Congress

Positive results from Elevation Pharmaceuticals’ EP-101 Phase 2b study on COPD

Sophiris announces data from PRX302 transrectal safety study on Benign Prostatic Hyperplasia

Astellas Pharma receives FDA approval for Xtandi to treat metastatic CRPC

Study reports flaws in design, analysis, and interpretation of Lyme disease

Promising results with SLIT for childhood grass pollen allergy

Janssen submits bedaquiline MAA with EMA for treatment of multi-drug resistant tuberculosis

Elan commences ELND005 Phase 2 study in Bipolar I Disorder

FDA approves Ironwood’s LINZESS to treat irritable bowel syndrome with constipation

Bayer submits regorafenib NDA with FDA for treatment of metastatic and/or unresectable GIST

Ironwood receives FDA approval for Linzess to treat chronic idiopathic constipation, IBS

Sosei’s QVA149 Phase III study on COPD meets primary endpoint

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

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