Headache News and Research

Latest Headache News and Research

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

FDA Advisory Committee votes in favor of expanding pain indications for Eli Lilly's Cymbalta

The U.S. Food and Drug Administration (FDA) Anesthetic and Life Support Drugs Advisory Committee voted 8-6 in favor of expanding the pain indications for Eli Lilly and Company's (NYSE: LLY) Cymbalta® (duloxetine HCl) to a broader pain population that will be further defined by the FDA, if approved.

20 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA, is also the first and only SCIg in the U.S. that may be stored at room temperature.

19 Aug 2010

Rush University Medical Center tests new drug therapy for West Nile fever

Neurological and infectious disease experts at Rush University Medical Center are testing a new drug therapy for the treatment of individuals with West Nile fever or suspected central nervous system infection due to the West Nile virus. Rush is the only site in the Midwest enrolling patients into the $50 million dollar, NIH-funded, Phase II clinical trial called PARADIGM.

18 Aug 2010

Physician recommends vaccination for Meningitis before children start school

Freshmen all across the nation have begun packing in preparation for college. Along with their laptops, notebooks, pens and binders, there is one more essential item they need - a meningitis vaccination. "If a student hasn't gotten a meningitis vaccination, they absolutely should get one before they start school," said Dr. Michael Koller, associate professor of medicine, division of general internal medicine, Loyola University Chicago Stritch School of Medicine, Maywood. "Meningitis is not a common disease but it can be tragic."

18 Aug 2010

Watson to launch ella emergency contraceptive in fourth-quarter 2010

Watson Pharmaceuticals, Inc., today announced that it intends to launch ella® (ulipristal acetate), a novel oral emergency contraceptive, in the fourth quarter of 2010. Watson's announcement follows the approval of ella® by the FDA as safe and effective in preventing unintended pregnancy for up to 120 hours – or five days – post-unprotected intercourse (UPI) or contraceptive failure.

16 Aug 2010

Headache News and Research

Latest Headache News and Research

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

FDA Advisory Committee votes in favor of expanding pain indications for Eli Lilly's Cymbalta

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

FDA approves CSL Behring's sBLA to extend shelf life of Hizentra from 18 to 24 months

Rush University Medical Center tests new drug therapy for West Nile fever

Physician recommends vaccination for Meningitis before children start school

Watson to launch ella emergency contraceptive in fourth-quarter 2010

How microRNA is transforming science: From discovery to diagnostics

Advancing benzodiazepine detection

The Surgeon-Scientist Pioneering Regenerative Engineering

Headache News and Research

Latest Headache News and Research

How microRNA is transforming science: From discovery to diagnostics

Advancing benzodiazepine detection

The Surgeon-Scientist Pioneering Regenerative Engineering

Newsletters you may be interested in