Headache News and Research

Latest Headache News and Research

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

FDA approves ellaOne for emergency contraception

HRA Pharma announced today that the US Food and Drug Administration (FDA) granted approval for ella(R) (ulipristal acetate) as a prescription-only emergency contraceptive indicated for use within 120 hours (five days) of unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.

16 Aug 2010

Lamictal can cause aseptic meningitis: FDA

The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.The agency is working with the drug's manufacturer, GlaxoSmithKline, to update the prescribing information and patient medication guide to include this risk.

13 Aug 2010

Tamir Biotechnology's three compounds effective show potential for yellow fever

Tamir Biotechnology, Inc.(formerly Alfacell Corporation) announced today that scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID) confirmed that testing of three of our company's compounds showed in vitro results rarely seen before by the U.S. government for yellow fever.

11 Aug 2010

Trigemina reports positive results from TI-001 Phase IIa clinical trial for Chronic Daily Headache

Trigemina, Inc., a Mountain View, CA based pharmaceutical company, reports positive results from its Phase IIa proof-of-concept clinical trial for TI-001 in Chronic Daily Headache. The trial is a collaborative effort between Trigemina and Dr. Egilius Spierings of MedVadis Research Corporation located outside of Boston, and compares intranasal TI-001 with placebo in patients suffering from CDH.

11 Aug 2010

NovoSeven RT in 8 mg vial for hemophilia A or B with inhibitors receives FDA approval

Novo Nordisk announced today that the U.S. Food and Drug Administration has approved NovoSeven® RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8 mg vial size, making the hemophilia A or B with inhibitors treatment available in 1, 2, 5 and 8 mg vials. The 8 mg vial allows a rapid initiation and administration of this medication for those patients who need a larger dose. In addition, FDA has also approved the extension of shelf life for all vial sizes from 24 months to 36 months at room temperature (at or below 77 degrees Fahrenheit).

11 Aug 2010

Labopharm launches antidepressant OLEPTRO for major depressive disorder in U.S.

Labopharm Inc. today announced that OLEPTRO(TM) (trazodone hydrochloride extended-release tablets), a novel once-daily formulation of the antidepressant trazodone, has been launched in the United States by its joint venture with Gruppo Angelini, Angelini Labopharm. OLEPTRO(TM) is indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of OLEPTRO(TM) has been established in a trial of outpatients with MDD as well as in trials with the immediate release formulation of trazodone.

11 Aug 2010

Vertex reports results from Phase 3 ILLUMINATE study of telaprevir-based therapy for hepatitis C

Vertex Pharmaceuticals Incorporated today announced results from the Phase 3 ILLUMINATE study, which was designed to evaluate whether there was any benefit to extending therapy from 24 to 48 weeks in people whose hepatitis C virus (HCV) was undetectable at weeks 4 and 12 of treatment (extended rapid viral response or eRVR).

10 Aug 2010

Three-year efficacy data on STELARA for psoriasis presented at American Academy of Dermatology meeting

New study findings showed that a majority of patients with moderate to severe plaque psoriasis who had a previous response to STELARA® (ustekinumab) sustained a clinical response for up to three years with continued treatment regardless of their body weight. Investigators also presented findings from an integrated safety analysis that included data from one Phase 2 and three Phase 3 trials in which treatment with STELARA demonstrated a favorable benefit-risk profile for up to three years of treatment, consistent with previous analyses.

10 Aug 2010

Endo to acquire Penwest for $5.00 per share

Endo Pharmaceuticals today announced actions designed to advance the company's leadership and growth in pain management, including an agreement to acquire all outstanding shares of Penwest Pharmaceuticals for $5.00 in cash per share, or an estimated enterprise value of approximately $144 million at the time of deal close. Penwest has been working with Endo since 1997 on the development and commercialization of OPANA® ER and receives a royalty stream on net sales of the product.

10 Aug 2010

NIH begins human clinical testing for dengue virus vaccine

After more than a decade of development at the National Institutes of Health, a vaccine to prevent infection by the mosquito-borne dengue virus has begun human clinical testing. The vaccine was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) and is undergoing clinical study at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

10 Aug 2010

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.

9 Aug 2010

Department of Agriculture advises consumers to discard Jersey Hollow Farm's raw milk

The Department of Agriculture today advised consumers who purchased raw milk from Norman Z. and Edith B. Sauder, of Jersey Hollow Farm in Kutztown, Berks County, to discard the product immediately because of potential bacterial contamination.

7 Aug 2010

ViroPharma announces data on safety, efficacy of Cinryze to treat acute angioedema attacks

ViroPharma Incorporated today announced that data from Phase 3 studies of Cinryze (C1 esterase inhibitor [human]) have been published in the August 5, 2010 issue of the New England Journal of Medicine. The paper entitled Nanofiltered C1 Inhibitor Concentrate for Treatment of Hereditary Angioedema by Dr. Bruce L. Zuraw et al. describes the safety and efficacy of Cinryze in treating and preventing attacks of hereditary angioedema. Cinryze is the first and only FDA-approved C1 esterase inhibitor therapy indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), a rare, debilitating and potentially fatal disease; it is not approved by the FDA to treat acute angioedema attacks.

6 Aug 2010

Dyax announces first Phase 3 trial results of KALBITOR for acute HAE

Dyax Corp. announced today that results from EDEMA3, the Company's first Phase 3 trial evaluating KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema, were published in the August issue of The New England Journal of Medicine. KALBITOR, discovered and developed by Dyax, is available in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older.

6 Aug 2010

Headache News and Research

Latest Headache News and Research

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

FDA approves ellaOne for emergency contraception

Lamictal can cause aseptic meningitis: FDA

Tamir Biotechnology's three compounds effective show potential for yellow fever

Trigemina reports positive results from TI-001 Phase IIa clinical trial for Chronic Daily Headache

NovoSeven RT in 8 mg vial for hemophilia A or B with inhibitors receives FDA approval

Labopharm launches antidepressant OLEPTRO for major depressive disorder in U.S.

Vertex reports results from Phase 3 ILLUMINATE study of telaprevir-based therapy for hepatitis C

Three-year efficacy data on STELARA for psoriasis presented at American Academy of Dermatology meeting

Endo to acquire Penwest for $5.00 per share

NIH begins human clinical testing for dengue virus vaccine

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Department of Agriculture advises consumers to discard Jersey Hollow Farm's raw milk

ViroPharma announces data on safety, efficacy of Cinryze to treat acute angioedema attacks

Dyax announces first Phase 3 trial results of KALBITOR for acute HAE

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Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

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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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