Headache News and Research

Latest Headache News and Research

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

Vyvanse Capsules CII demonstrates significant improvement in adults with ADHD: Phase 3b study

Shire plc, the global specialty biopharmaceutical company, today announced that a Phase 3b study published in Behavioral and Brain Functions found adults with Attention Deficit Hyperactivity Disorder who took once-daily Vyvanse (lisdexamfetamine dimesylate) Capsules CII demonstrated significant improvement in attention.

6 Aug 2010

TEMPO study recommends early administration of Azilect in PD patients

Teva Pharmaceutical Industries Ltd. and H. Lundbeck A/S (Lundbeck) today announced newly published long-term data on Azilect(rasagiline tablets) from the TEMPO study and its open-label extension. The findings confirm the long-term efficacy, safety and tolerability of Azilect® in patients with Parkinson's disease (PD) and further demonstrate the benefits obtained with early treatment initiation. The data was published in the June 2010 issue of the International Journal of Neuroscience.

6 Aug 2010

YM concludes dose-escalation in CYT387 Phase I/II clinical trial for myelofibrosis

YM BioSciences Inc., announced the conclusion of dose-escalation in the Phase I portion of its Phase I/II clinical trial of CYT387 at Mayo Clinic in patients with myelofibrosis. In total, 21 patients were treated in Phase I, with no voluntary withdrawals reported. CYT387 has shown significant activity in reducing spleen size and controlling constitutional symptoms in these patients.

5 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

Long-term exposure to valproate leads to bone loss: Study

Scientists are reporting a possible explanation for the bone loss that may occur following long-term use of a medicine widely used to treat epilepsy, bipolar disorder, and other conditions. The drug, valproate, appears to reduce the formation of two key proteins important for bone strength, they said. Their study, which offers a solution to a long-standing mystery, appears in ACS' monthly Journal of Proteome Research.

5 Aug 2010

Contrave added to diet and exercise regimen can induce significant weight loss

Orexigen Therapeutics, Inc. announced the online publication of results from its COR-BMOD trial of Contrave (naltrexone SR/bupropion SR) in the journal Obesity. The COR-BMOD trial evaluated intensive behavior modification plus Contrave32 (32mg naltrexone sustained release (SR)/360mg bupropion SR) compared to BMOD plus placebo, in 793 overweight or obese patients.

4 Aug 2010

Headache News and Research

Latest Headache News and Research

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

Vyvanse Capsules CII demonstrates significant improvement in adults with ADHD: Phase 3b study

TEMPO study recommends early administration of Azilect in PD patients

YM concludes dose-escalation in CYT387 Phase I/II clinical trial for myelofibrosis

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Long-term exposure to valproate leads to bone loss: Study

Contrave added to diet and exercise regimen can induce significant weight loss

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