Headache News and Research

Latest Headache News and Research

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.

3 Sep 2010

Botox maker agrees to pay $600 million for misbranding

The Associated Press: "Allergan Inc., the maker of wrinkle-smoothing Botox, has agreed to pay $600 million to settle a yearslong federal investigation into its marketing of the top-selling, botulin-based drug. The Justice Department and the company said Wednesday in a statement it will plead guilty to one misdemeanor charge of 'misbranding,' in which the company's marketing led physicians to use Botox for unapproved uses. Those included the treatment of headache, pain, spasticity and cerebral palsy in children.

3 Sep 2010

Inhibitex completes INX-189 Phase1a trial for HCV

Inhibitex, Inc., announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting.

2 Sep 2010

Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic osteoarthritis knee pain have been published by Clinical Drug Investigation.

31 Aug 2010

FDA approves additional strengths of SOLODYN for inflammatory lesions treatment

Medicis today announced that the U.S. Food and Drug Administration (FDA) has approved additional strengths of SOLODYN (minocycline HCl, USP) Extended Release Tablets in 55 mg, 80 mg and 105 mg dosages for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

30 Aug 2010

Shire receives European marketing approval for VPRIV therapy to treat type 1 Gaucher disease

Shire, the global specialty biopharmaceutical company, announced today that the European Commission has granted marketing authorisation for VPRIV(R) (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease.

27 Aug 2010

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.

27 Aug 2010

FDA accepts Sanofi Pasteur's Menactra vaccine sBLA for active immunization of infants and toddlers

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for use of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for active immunization of infants and toddlers for the prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135.

26 Aug 2010

Department of Health reports 2010's first human case of West Nile virus in Pennsylvania

The Department of Health today reported this year's first human case of West Nile virus in Pennsylvania. The individual is a 69-year-old man from Philadelphia County.

26 Aug 2010

Biogen to publish data on two-step assay for anti-JC virus antibody detection

Biogen Idec and Elan Corporation, plc today announced data has been published in the Annals of Neurology on an investigational, two-step assay to detect anti-JC virus (JCV) antibodies in human serum and plasma

26 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Migraine with aura increases risk of heart disease: Research

Individuals who suffer from migraines with aura (temporary visual or sensory disturbances before or during a migraine headache) are at a higher risk of dying from heart disease or stroke.

25 Aug 2010

Eisai's Phase III trial of Perampanel for epilepsy shows positive results

The double-blind, placebo-controlled, parallel-group study (Study 306) showed that perampanel was well-tolerated and effective in reducing median seizure frequency and increasing responder rates, the primary outcome measures in the United States and European Union, respectively. The findings were highly statistically significant in 4 mg and 8 mg doses compared to placebo.

25 Aug 2010

Baxter announces definitive agreement with Kamada for GLASSIA alpha1-proteinase inhibitor

Baxter International Inc. today announced a definitive agreement with Kamada Ltd. for exclusive commercial rights to GLASSIA™ [Alpha 1-Proteinase Inhibitor (Human)], the first and only liquid alpha1-proteinase inhibitor, in the United States, Australia, New Zealand and Canada.

From Baxter International Inc. 24 Aug 2010

Multidisciplinary approach to treat neck and back pain caused by accidents, injuries

Advanced Spine and Headache Center is pleased to announce their expansion into a multidisciplinary approach for the treatment of neck and back pain caused by an auto accident, sports injury, or work related injury. "Our main objective was to integrate physical medicine, chiropractic, physical and massage therapy, and family medicine under one location," said founder Dr. Alex Meltser.

23 Aug 2010

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Genzyme Corporation announced today that the two-year follow-up results from the phase 2 clinical trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood. The results have been pre-published on the journal's website and are available to subscribers.

23 Aug 2010

Novo Nordisk reaches exclusive agreement to market Vagifem 10 mcg

Novo Nordisk Inc. today announced that it has signed an exclusive agreement with Upsher-Smith Laboratories, Inc. to market Vagifem (estradiol vaginal tablets) 10 mcg. Under the terms of the agreement, Upsher-Smith will exclusively market Vagifem 10 mcg to physicians in the U.S. beginning August 2 through the company's existing field sales force.

23 Aug 2010

FDA approves Alexion's Rhode Island manufacturing facility as commercial supply source for Soliris

Alexion Pharmaceuticals, Inc. today announced that the US Food and Drug Administration (FDA) has approved Alexion's Rhode Island manufacturing facility (ARIMF) in Smithfield, Rhode Island as a second source of commercial supply for Soliris® (eculizumab).

23 Aug 2010

FDA warns of typhoid fever through frozen mamey fruit pulp

The U.S. Food and Drug Administration is warning consumers not to eat frozen mamey fruit pulp sold under the La Nuestra brand by Montalvan Sales Inc. Ontario, Calif., or the Goya brand by Goya Foods Inc. Secaucus, N.J.

21 Aug 2010

Headache News and Research

Latest Headache News and Research

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Botox maker agrees to pay $600 million for misbranding

Inhibitex completes INX-189 Phase1a trial for HCV

Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

FDA approves additional strengths of SOLODYN for inflammatory lesions treatment

Shire receives European marketing approval for VPRIV therapy to treat type 1 Gaucher disease

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

FDA accepts Sanofi Pasteur's Menactra vaccine sBLA for active immunization of infants and toddlers

Department of Health reports 2010's first human case of West Nile virus in Pennsylvania

Biogen to publish data on two-step assay for anti-JC virus antibody detection

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Migraine with aura increases risk of heart disease: Research

Eisai's Phase III trial of Perampanel for epilepsy shows positive results

Baxter announces definitive agreement with Kamada for GLASSIA alpha1-proteinase inhibitor

Multidisciplinary approach to treat neck and back pain caused by accidents, injuries

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Novo Nordisk reaches exclusive agreement to market Vagifem 10 mcg

FDA approves Alexion's Rhode Island manufacturing facility as commercial supply source for Soliris

FDA warns of typhoid fever through frozen mamey fruit pulp

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

Headache News and Research

Latest Headache News and Research

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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