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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

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

Immune Network, a company in the business of development and commercialization of immune therapies, announced today that its newly acquired business, Immunitor, has published interim data from the ongoing Phase IIb imm01 clinical trial of V5 in tuberculosis conducted at its second site in Ukraine.

24 Jan 2011

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

R-Tech Ueno, is pleased to announce that the Phase 2a clinical study of RK-023 to treat androgenetic alopecia was completed by January 21, 2011.

24 Jan 2011

SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

Scientists ignore relevant drug clinical trials when conducting new research on same topic

The vast majority of already published and relevant clinical trials of a given drug, device or procedure are routinely ignored by scientists conducting new research on the same topic, a new Johns Hopkins study suggests.

24 Jan 2011

EMA CHMP issues negative opinion against Biogen Idec's FAMPYRA for multiple sclerosis

Biogen Idec announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion recommending against approval of FAMPYRA to improve walking ability in adult patients with multiple sclerosis (MS) in the European Union. Biogen Idec intends to appeal this opinion and request a re-examination of the decision by the CHMP.

21 Jan 2011

Major breakthrough: Genome-based medicine for treatment of alcoholism

For the first time in alcohol addiction research, UVA investigators have successfully treated alcohol-dependent individuals with medication that is tailored specifically to match their genetic profile.

21 Jan 2011

Placebo News and Research

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

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

SuppreMol completes successful pre-IND meeting with U.S. FDA

Scientists ignore relevant drug clinical trials when conducting new research on same topic

EMA CHMP issues negative opinion against Biogen Idec's FAMPYRA for multiple sclerosis

Major breakthrough: Genome-based medicine for treatment of alcoholism

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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