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Avanir files IND for NUEDEXTA/AVP-923 Phase II clinical trial for central neuropathic pain in MS patients

Avanir Pharmaceuticals, Inc. today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a large Phase II clinical trial of AVP-923, an investigational drug for the treatment of central neuropathic pain in patients with multiple sclerosis (MS). The FDA has acknowledged receipt of the submission and the company expects that the IND filing will be subject to standard 30-day review.

4 Apr 2011

Abbott and Enanta's ABT-450/r Phase 2 study results against HCV presented at EASL meeting

Abbott and Enanta Pharmaceuticals today announced 12-week results from a Phase 2 study of ABT-450/r, an investigational, oral protease inhibitor being developed for the treatment of hepatitis C infection.

4 Apr 2011

BMY announces BMS-790052 plus PEG-Interferon alfa and RBV Phase II trial results against HCV

Bristol-Myers Squibb Company today announced results from a Phase II clinical trial in which treatment with the investigational direct-acting antiviral BMS-790052, an NS5A replication complex inhibitor, in combination with PEG-Interferon alfa and ribavirin, achieved sustained virologic response 12 weeks post-treatment in up to 92% of treatment-naïve patients chronically infected with hepatitis C genotype 1.

4 Apr 2011

Positive results from GDC-0449 Phase II data against basal cell nevus syndrome

A new hedgehog pathway inhibitor demonstrated efficacy in preventing and treating basal cell cancer among patients with basal cell nevus syndrome, a rare inheritable disease, according to Phase II data presented at the AACR 102nd Annual Meeting 2011, held April 2-6.

4 Apr 2011

Boehringer Ingelheim's BI 201335 new data against HCV highlighted at EASL meeting

New data presented today at the International Liver CongressTM 2011, the 46th Annual Meeting of the European Association for the Study of the Liver, in Berlin, highlighted the efficacy of Boehringer Ingelheim's once-daily oral protease inhibitor BI 201335, in both treatment-naïve and -experienced patients with chronic genotype-1 hepatitis C virus infection. Genotype-1 HCV is the most challenging genotype of HCV to treat.

2 Apr 2011

Thalidomide provides new hope for patients with difficult to treat liver cancer

Thalidomide has shown potential to be used as the first adjuvant therapy for hepatocellular carcinoma, according to data presented at the International Liver Congress 2011.

2 Apr 2011

Boehringer Ingelheim advances into Phase 3 clinical trial of BI 201335

Boehringer Ingelheim today announced a preview of the study designs for the pivotal Phase 3 clinical trials evaluating BI 201335, its investigational once-daily oral protease inhibitor, in both treatment-naive and -experienced patients with chronic genotype-1 hepatitis C virus, the most challenging genotype to treat.

2 Apr 2011

Results of Boehringer Ingelheim's BI 201335 study presented at Annual Meeting of EASL

New data presented today at the 46th Annual Meeting of the European Association for the Study of the Liver demonstrate the antiviral activity of Boehringer Ingelheim's once-daily oral protease inhibitor, BI 201335, in both treatment-naive and -experienced patients with chronic genotype-1 hepatitis C virus, the most challenging genotype of HCV to treat.

1 Apr 2011

APEX-PD Phase III clinical study data to be presented at American Academy of Neurology Conference

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., today announced that IPX066 APEX-PD Phase III clinical study data will be presented in a Late Breaker Session at the 63rd annual meeting of the American Academy of Neurology Conference in Honolulu, Hawaii, held from April 9 to April 16.

1 Apr 2011

Obeticholic Acid safe and effective against Primary Biliary Cirrhosis

Results from an international study presented today at the International Liver Congress have shown Obeticholic Acid (OCA) is a safe and effective treatment in patients suffering from Primary Biliary Cirrhosis (PBC) as demonstrated by substantial decreases in the levels of alkaline phosphatase (AP) enzyme in the blood, a key marker for PBC.

1 Apr 2011

Novartis, Intercell to initiate Pseudomonas vaccine trial in ventilated ICU patients

Today Intercell AG announced that it has agreed with Novartis to advance Intercell's investigational Pseudomonas aeruginosa vaccine into a confirmatory clinical efficacy trial in ventilated ICU patients.

1 Apr 2011

Tibotec presents TMC435 phase 2b study interim results against HCV at EASL meeting

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces that their partner, Tibotec has presented the results of a planned Week 24 interim analysis of the phase 2b ASPIRE study for TMC435 in treatment experienced hepatitis C patients in a late-breaker session at the 46th Annual meeting of the European Association for the Study of the Liver, Berlin, Germany.

1 Apr 2011

CorMedix reports encouraging interim results from CRMD001 phase II study in Contrast Induced Acute Kidney Injury

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, today announced its interim analysis and clinical update for CRMD001.

1 Apr 2011

New data confirms antiviral activity of fluvastatin in patients with HCV

New data presented today at the International Liver CongressTM confirm the antiviral activity of fluvastatin -- commonly used as a cholesterol-lowering treatment -- in patients with chronic hepatitis C.

1 Apr 2011

Vertex announces final results from Phase 3 REALIZE study against HCV

Vertex Pharmaceuticals Incorporated today announced final results from its pivotal Phase 3 REALIZE study that evaluated people with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon and ribavirin was unsuccessful either because they relapsed, had a partial response or had a null response.

1 Apr 2011

Syndax to present entinostat data against cancer at AACR meeting

Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, today announced 11 posters on entinostat, an oral, highly selective, class I histone deacetylase inhibitor, will be presented at the 102nd Annual American Association for Cancer Research meeting April 2 to April 6 in Orlando, FL.

1 Apr 2011

Watson, GeneraMedix receive FDA approval for Nulecit to treat iron deficiency anemia

Watson Pharmaceuticals, Inc. today announced that it is initiating launch activities of Nulecit, following FDA approval of GeneraMedix Inc.'s, Abbreviated New Drug Application.

1 Apr 2011

Positive results from Intercept OCA Phase II trial in patients with PBC

Intercept Pharmaceuticals, Inc., today announced positive results from a 59 patient, placebo controlled, double-blind Phase II clinical trial of obeticholic acid given as monotherapy to patients with primary biliary cirrhosis.

1 Apr 2011

Anavex screening volunteers for phase I, first-in-human clinical study in Alzheimer’s

Anavex Life Sciences Corp. today announced screening of the first healthy volunteers for the Phase I clinical study of ANAVEX 2-73, its lead compound for the treatment of Alzheimer’s disease. ANAVEX 2-73 is the first of a new class of wholly-owned, oral, disease-modifying compounds, which act through sigma-1 receptor agonist as well as muscarinic cholinergic effects and up-regulation of Bcl-2.

31 Mar 2011

Vanda to initiate tasimelteon Phase IIb/III clinical trial in Major Depressive Disorder

Vanda Pharmaceuticals Inc. today announced its plans to initiate a Phase IIb/III clinical trial of tasimelteon in patients with Major Depressive Disorder (MDD). The trial is expected to begin during the second half of 2011. Tasimelteon is currently being evaluated in Phase III clinical trials for the treatment of Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals without light perception.

31 Mar 2011

Placebo News and Research

Avanir files IND for NUEDEXTA/AVP-923 Phase II clinical trial for central neuropathic pain in MS patients

Abbott and Enanta's ABT-450/r Phase 2 study results against HCV presented at EASL meeting

BMY announces BMS-790052 plus PEG-Interferon alfa and RBV Phase II trial results against HCV

Positive results from GDC-0449 Phase II data against basal cell nevus syndrome

Boehringer Ingelheim's BI 201335 new data against HCV highlighted at EASL meeting

Thalidomide provides new hope for patients with difficult to treat liver cancer

Boehringer Ingelheim advances into Phase 3 clinical trial of BI 201335

Results of Boehringer Ingelheim's BI 201335 study presented at Annual Meeting of EASL

APEX-PD Phase III clinical study data to be presented at American Academy of Neurology Conference

Obeticholic Acid safe and effective against Primary Biliary Cirrhosis

Novartis, Intercell to initiate Pseudomonas vaccine trial in ventilated ICU patients

Tibotec presents TMC435 phase 2b study interim results against HCV at EASL meeting

CorMedix reports encouraging interim results from CRMD001 phase II study in Contrast Induced Acute Kidney Injury

New data confirms antiviral activity of fluvastatin in patients with HCV

Vertex announces final results from Phase 3 REALIZE study against HCV

Syndax to present entinostat data against cancer at AACR meeting

Watson, GeneraMedix receive FDA approval for Nulecit to treat iron deficiency anemia

Positive results from Intercept OCA Phase II trial in patients with PBC

Anavex screening volunteers for phase I, first-in-human clinical study in Alzheimer’s

Vanda to initiate tasimelteon Phase IIb/III clinical trial in Major Depressive Disorder

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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