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AVANIR's NUEDEXTA for pseudobulbar affect now available by prescription

AVANIR Pharmaceuticals, Inc. today announced that NUEDEXTA™ (dextromethorphan hydrobromide and quinidine sulfate) is now available by prescription in the United States. NUEDEXTA is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for pseudobulbar affect (PBA).

1 Feb 2011

MAP Pharmaceuticals, Allergan collaborate for LEVADEX to treat acute migraine in adults

Allergan, and MAP Pharmaceuticals, today announced a collaboration within the United States for LEVADEX, a self-administered, orally inhaled therapy that has completed Phase III clinical development for the treatment of acute migraine in adults.

31 Jan 2011

Maxygen initiates Phase I study to evaluate CTLA4-Ig therapeutic for treatment of rheumatoid arthritis

Maxygen, a biotechnology company focused on the development of improved protein drugs, today announced the initiation of a Phase I clinical study to evaluate a next-generation CTLA4-Ig therapeutic that is being developed by Perseid Therapeutics LLC, Maxygen's majority-owned subsidiary, in collaboration with Astellas Pharma Inc. for the treatment of rheumatoid arthritis and potentially other autoimmune indications.

31 Jan 2011

GATTEX Phase 3 pivotal study reaches primary efficacy endpoint of reducing PN in patients with SBS

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced that its Phase 3 pivotal study of GATTEX met the primary efficacy endpoint of reducing parenteral nutrition dependence in patients with adult short bowel syndrome.

31 Jan 2011

Phase III study shows tapentadol ER relieves chronic pain associated with DPN

New research has been published indicating that patients suffering from a painful complication of diabetes may experience a significant improvement in their pain as measured by a pain intensity scale when using an investigational pain medication.

29 Jan 2011

Exposure to infections in early childhood can protect child from eczema later in life: Study

Exposure to worm infections in the womb may protect a newborn infant from developing eczema, a study funded by the Wellcome Trust suggests. A large trial in Uganda showed that treating a pregnant woman for worm infections increased her child's chances of developing the allergic skin disease.

29 Jan 2011

FDA approves GRALISE Tablets for treatment of PHN

Depomed, Inc. today announced that US FDA has approved GRALISE (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia, which is pain following healing of the rash associated with shingles.

29 Jan 2011

Phase II trial finds fostamatinib ineffective in RA patients not responsive to biologic agents

In a previous study, rheumatoid arthritis (RA) patients who failed to respond to methotrexate were shown to experience positive results with fostamatinib disodium (R788), an oral spleen tyrosine kinase (Syk) inhibitor that is thought to block immune cell signaling involved with bone and cartilage destruction. In the current study, RA patients who failed to respond to biologic agents were studied.

28 Jan 2011

CSL Behring receives marketing approval for HAE drug Berinert in Israel

CSL Behring announced today it has been granted national marketing authorization in Israel to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. With this most recent approval, Berinert is now licensed in 30 countries, including Europe, Japan, North America, South America and Australia.

28 Jan 2011

Phase III study affirms safety and efficacy of Cumberland's Caldolor for post-operative pain

Cumberland Pharmaceuticals Inc. today announced the publication of data affirming the safety and efficacy of Caldolor® (ibuprofen) Injection in treating post-operative pain in hospitalized patients. A Phase III study published in the peer-reviewed journal Pain Practice concluded that IV ibuprofen significantly reduced both morphine use and self-reported pain intensity in patients recovering from abdominal hysterectomy compared to morphine alone.

27 Jan 2011

AB Science initiates recruitment in masitinib phase 3 study in severe persistent asthma

AB Science SA, a pharmaceutical company specialising in the research, development and commercialisation of protein kinase inhibitors (PKIs), announced today the recruitment of the first patient in the phase 3 study evaluating masitinib in severe persistent asthma.

27 Jan 2011

Diamyd Medical reports first quarter group total net sales of MSEK 144.5

Diamyd completed screening for US Phase III study in type 1 diabetes. The screening of patients for the US Phase III study, DiaPrevent, was completed, ending the recruitment campaign. More than 310 recently diagnosed type 1 diabetes patients between 10 and 20 years of age had, at the completion of screening, been enrolled in the study and received their first injection of the antigen-based therapy Diamyd® or placebo.

25 Jan 2011

Researchers show shunt operation can help patients with dementia

Researchers from the University of Gothenburg and Sahlgrenska University Hospital are the first in the world to show that an operation can help patients with dementia caused by white matter changes and hydrocephalus.

25 Jan 2011

Eisai to seek marketing authorization for perampanel in the U.S. and EU

Eisai announced today that it will submit Marketing Authorization Applications in the United States and the European Union for the investigational compound perampanel (E2007) based on the results of three Phase III pivotal studies. Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai for adjunctive treatment of partial onset seizures in patients with epilepsy.

25 Jan 2011

Eisai's eritoran ACCESS study in severe sepsis does not meet primary endpoint

Based on the preliminary findings from the ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial, Eisai Inc. announced today that the company will not submit marketing authorization applications to regulatory authorities in the United States, the European Union and Japan by the end of the fiscal year (March 31, 2011), as previously planned.

25 Jan 2011

Diamyd Medical to report European Phase III trial results for type 1 diabetes

Diamyd Medical's President and CEO Elisabeth Lindner states in the CEO comments in today's quarterly report that the Company expects to begin reporting the results from the European Phase III trial in type 1 diabetes as planned in late spring 2011.

25 Jan 2011

Promising results from TheraTears Nutrition pilot trial in dry eye patients

Advanced Vision Research, Inc. today announced the publication in the journal Cornea of promising results from a pilot trial of dry eye patients taking TheraTears® Nutrition. The study demonstrated a reduction in dry eye symptoms and an increase in tear volume and tear flow for those patients taking TheraTears® Nutrition, an optimized blend of medical grade essential omega-3 oils, including eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and flaxseed oil.

25 Jan 2011

Alexza's AZ-004 Phase 3 study in agitated patients with schizophrenia published in British Journal of Psychiatry

Alexza Pharmaceuticals, Inc. announced today that the British Journal of Psychiatry, a publication of the Royal College of Psychiatrists, has published the results of the pivotal Phase 3 study evaluating AZ-004 (inhaled or Staccato® loxapine) for the rapid treatment of agitation in patients with schizophrenia, in its January 2011 edition (198:51-58).

24 Jan 2011

Northwest Biotherapeutics resumes enrollment in DCVax Phase II clinical trial for GBM brain cancer

Northwest Biotherapeutics announced today that the Company is resuming enrollment of additional new patients into its ongoing 240-patient, double blind, randomized, placebo controlled Phase II clinical trial of DCVax for Glioblastoma multiforme brain cancer.

24 Jan 2011

FDA approves Clinical Data's Viibryd for major depressive disorder

Clinical Data, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD).

24 Jan 2011

Placebo News and Research

AVANIR's NUEDEXTA for pseudobulbar affect now available by prescription

MAP Pharmaceuticals, Allergan collaborate for LEVADEX to treat acute migraine in adults

Maxygen initiates Phase I study to evaluate CTLA4-Ig therapeutic for treatment of rheumatoid arthritis

GATTEX Phase 3 pivotal study reaches primary efficacy endpoint of reducing PN in patients with SBS

Phase III study shows tapentadol ER relieves chronic pain associated with DPN

Exposure to infections in early childhood can protect child from eczema later in life: Study

FDA approves GRALISE Tablets for treatment of PHN

Phase II trial finds fostamatinib ineffective in RA patients not responsive to biologic agents

CSL Behring receives marketing approval for HAE drug Berinert in Israel

Phase III study affirms safety and efficacy of Cumberland's Caldolor for post-operative pain

AB Science initiates recruitment in masitinib phase 3 study in severe persistent asthma

Diamyd Medical reports first quarter group total net sales of MSEK 144.5

Researchers show shunt operation can help patients with dementia

Eisai to seek marketing authorization for perampanel in the U.S. and EU

Eisai's eritoran ACCESS study in severe sepsis does not meet primary endpoint

Diamyd Medical to report European Phase III trial results for type 1 diabetes

Promising results from TheraTears Nutrition pilot trial in dry eye patients

Alexza's AZ-004 Phase 3 study in agitated patients with schizophrenia published in British Journal of Psychiatry

Northwest Biotherapeutics resumes enrollment in DCVax Phase II clinical trial for GBM brain cancer

FDA approves Clinical Data's Viibryd for major depressive disorder

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