Headache News and Research

Latest Headache News and Research

CHMP recommends approval of Centralized Marketing Authorization for Cinryze

ViroPharma Incorporated today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion at its plenary meeting in March 2011 recommending approval of a Centralized Marketing Authorization for Cinryze (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks.

19 Mar 2011

BioMarin announces preliminary results from ADAPT in patients suffering from PKU

BioMarin Pharmaceutical Inc. announced today preliminary results from ADAPT (A Diversified Approach for PKU Treatment) in an abstract (Abstract #91, Mental Health Screening in Phenylketoniuria Clinic) presented by Barbara Burton, MD at the 2011 annual American College of Medical Genetics conference in Vancouver, Canada.

19 Mar 2011

Gadavist approved by FDA for use in central nervous system MRI scans

The U.S. Food and Drug Administration approved Gadavist (gadobutrol), a gadolinium-based contrast agent, for use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system.

16 Mar 2011

Bayer receives FDA approval for Gadavist Injection

Bayer HealthCare Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration has approved Gadavist Injection, a macrocyclic gadolinium-based contrast agent, for intravenous use in diagnostic magnetic resonance imaging in adults and children to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

14 Mar 2011

Genentech announces positive outcomes from Lucentis Phase III trial against DME

Genentech, a member of the Roche Group, today announced that two-year results from a pivotal Phase III trial showed patients with diabetic macular edema who received Lucentis experienced rapid and sustained improvement in vision compared to those who received a placebo injection.

11 Mar 2011

Researchers develop web-based approach to solve personal health assessment problem

Health literacy is a prerequisite for well being in the developed world with five out of five ailments being treatable by patients themselves given access to appropriate information.

11 Mar 2011

Novartis new MS treatment receives Notice of Compliance in Canada

Novartis Pharmaceuticals Canada Inc. announced today that its new MS treatment, Gilenya, has received Notice of Compliance in Canada.

10 Mar 2011

Positive results from exenatide phase 2 study in patients with type 2 diabetes

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes.

10 Mar 2011

FDA approves BENLYSTA for active, autoantibody-positive systemic lupus erythematosus

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced that the U.S. Food and Drug Administration has approved BENLYSTA® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

10 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

Novartis QAB149 receives FDA Pulmonary-Allergy Advisory Committee approval for COPD

An advisory committee recommended today that the Food and Drug Administration (FDA) approve QAB149 (indacaterol) 75 mcg in the US as a once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

9 Mar 2011

Treatment with sildenafil significantly reduces RP in patients with scleroderma

Researchers in Europe reported that treatment with modified-release sildenafil significantly reduced the frequency of attacks of Raynaud's phenomenon in patients with limited cutaneous systemic sclerosis, also known as scleroderma.

8 Mar 2011

Recent rituximab trial with TNF inhibitors reports no new safety risks in patients with RA

A recent trial of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis found the safety profile to be consistent with other RA trials with TNF inhibitors.

8 Mar 2011

FDA approves change to prescribing information for Gilead Sciences' Letairis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved a change to the prescribing information for Letairis (ambrisentan 5 mg and 10 mg tablets), the company's once-daily treatment to improve exercise ability and delay clinical worsening in pulmonary arterial hypertension (PAH, WHO Group 1) patients with predominantly WHO Functional Class II-III symptoms.

5 Mar 2011

Eisai receives FDA approval for BANZEL Oral Suspension to treat seizures linked with LGS

Eisai Inc. today announced that the U.S. Food and Drug Administration has approved BANZEL Oral Suspension, 40 mg/mL, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

3 Mar 2011

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Vertex Pharmaceuticals Incorporated announced today interim results from an ongoing, two-part, Phase 2 study evaluating telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone in people who are infected with both genotype 1 hepatitis C virus and human immunodeficiency virus, also known as HCV-HIV co-infection.

3 Mar 2011

Omeros identifies orphan GPCR compounds associated to pancreatic cancer, cognitive disorders

Omeros Corporation today announced that it has identified compounds that interact selectively with two orphan G protein-coupled receptors linked to pancreatic cancer and cognitive disorders.

3 Mar 2011

Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

Baxter International Inc. announced today the approval of a European repeat mutual recognition procedure (rMRP) by the Austrian Agency for Health and Food Safety for Baxter's PREFLUCEL seasonal influenza vaccine. The 13 participating European Union countries, including Germany, Spain, United Kingdom and Nordic countries, will formally implement the license on a national level to make PREFLUCEL available for the 2011-12 influenza season.

From Baxter International Inc. 2 Mar 2011

FDA approves roflumilast to treat COPD

The U.S. Food and Drug Administration approved roflumilast, a pill taken daily to decrease the frequency of flare-ups or worsening of symptoms from severe chronic obstructive pulmonary disease.

1 Mar 2011

New drug approved for COPD by the FDA

The U.S. FDA has approved a new treatment for people with worsening symptoms of severe chronic obstructive pulmonary disease (COPD). COPD affects smokers and the elderly and leads to severe difficulty in breathing, chronic cough and excessive mucus production. An exacerbation can last up to several weeks and result in a decline in lung function and increased risk of death, and it may be associated with severe anxiety, the FDA says.

1 Mar 2011

Headache News and Research

Latest Headache News and Research

CHMP recommends approval of Centralized Marketing Authorization for Cinryze

BioMarin announces preliminary results from ADAPT in patients suffering from PKU

Gadavist approved by FDA for use in central nervous system MRI scans

Bayer receives FDA approval for Gadavist Injection

Genentech announces positive outcomes from Lucentis Phase III trial against DME

Researchers develop web-based approach to solve personal health assessment problem

Novartis new MS treatment receives Notice of Compliance in Canada

Positive results from exenatide phase 2 study in patients with type 2 diabetes

FDA approves BENLYSTA for active, autoantibody-positive systemic lupus erythematosus

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Novartis QAB149 receives FDA Pulmonary-Allergy Advisory Committee approval for COPD

Treatment with sildenafil significantly reduces RP in patients with scleroderma

Recent rituximab trial with TNF inhibitors reports no new safety risks in patients with RA

FDA approves change to prescribing information for Gilead Sciences' Letairis

Eisai receives FDA approval for BANZEL Oral Suspension to treat seizures linked with LGS

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Omeros identifies orphan GPCR compounds associated to pancreatic cancer, cognitive disorders

Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

FDA approves roflumilast to treat COPD

New drug approved for COPD by the FDA

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Headache News and Research

Latest Headache News and Research

CellVoyant's AI-Powered Vision for the Future of Cell Therapy

Scalable, Smart, and Accessible: The Future of Lab Automation

Healthy Beginnings, Hopeful Futures: A Conversation with WHO’s Dr. Allotey

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