Headache News and Research

Latest Headache News and Research

Xeomin receives approval for post-stroke spasticity of upper limb in European countries

Today, Merz Pharmaceuticals announced Xeomin®, the first botulinum toxin type A free from complexing proteins has been granted an extension of indication for post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults in various European countries.

19 Nov 2009

Once-a-day dosing clinical study of udenafil for erectile dysfunction completed

Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced today that it has completed a 240 patient once-a-day dosing clinical study of udenafil, its new long acting phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED).

19 Nov 2009

Millennium commences Phase I clinical trial for its second-generation proteasome inhibitor

Millennium: The Takeda Oncology Company today announced it has further expanded its protein homeostasis program with the initiation of a Phase I clinical trial for an oral formulation of MLN9708, the Company’s second-generation proteasome inhibitor. An intravenous formulation of MLN9708 entered clinical trials in March.

18 Nov 2009

Clinical Data commences patient enrollment in Stedivaze Phase III trial

Clinical Data, Inc. today announced that it has enrolled the first patient in its initial Phase III trial of Stedivaze™, a potential best-in-class vasodilator for use in cardiac stress testing. The study will evaluate the safety and efficacy of Stedivaze (apadenoson) for use as a pharmacologic stress agent in myocardial perfusion imaging (MPI), a method for detecting defects in the blood supply to the heart.

18 Nov 2009

Positive results from REVIVE, a phase 3 pivotal study of avanafil announced

VIVUS, Inc. today announced positive results from REVIVE (TA-301), a phase 3 pivotal study evaluating the safety and efficacy of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED), in 646 patients.

18 Nov 2009

Entellus Medical completes its Series D financing totaling $30MM

Entellus Medical, the Minnesota-based developer of novel, less invasive treatments for chronic conditions of sinusitis, has completed its Series D financing totaling $30MM. The Series D round was led by new investor Essex Woodlands Health Ventures and supported by existing investors Split Rock Partners and SV Life Sciences.

17 Nov 2009

Shire publishes new study results on INTUNIV Extended-Release Tablets

Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone.

17 Nov 2009

Genentech submits sBLAs to the FDA for Avastin

Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). One sBLA is based on the Phase III study AVADO that investigated Avastin in combination with docetaxel chemotherapy.

17 Nov 2009

Migraine headaches linked with increased risk of common kind of stroke

Pooling results from 21 studies, involving 622,381 men and women, researchers at Johns Hopkins have affirmed that migraine headaches are associated with more than twofold higher chances of the most common kind of stroke: those occurring when blood supply to the brain is suddenly cut off by the buildup of plaque or a blood clot.

16 Nov 2009

FDA approves Lysteda for treating menorrhagia

Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S. Food and Drug Administration (FDA) approval for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia.

16 Nov 2009

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Alkermes, Inc. today announced positive preliminary results from a phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002).

16 Nov 2009

Positive results from Winston Laboratories' Civamide Patch trial

Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. today announced positive top-line results from Study WL1001-04-03, a Phase II clinical trial evaluating the safety and efficacy of the company's patch formulation of Civamide, a novel TRPV-1 receptor modulator in the treatment of post-herpetic neuralgia (PHN).

16 Nov 2009

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse-. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

16 Nov 2009

Shire announces findings from Phase 3 study data with Vyvanse

Shire plc, the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

13 Nov 2009

Transcept Pharmaceuticals reports financial results for the third quarter of 2009

Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience, today announced financial results for the three and nine months ended September 30, 2009.

13 Nov 2009

Exposure to deadly bacteria can result in stillbirths

A new study shows the risk for severe effects of exposure to Listeria monocytogenes among susceptible populations may occur at doses lower than suggested by previous studies.

13 Nov 2009

Tobira Therapeutics presents data on TBR-652 at the European AIDS Conference

Tobira Therapeutics, a clinical stage biotechnology company committed to research and product discovery for the treatment of life-threatening and life-altering infectious diseases, today announced pharmacokinetic data and results from two double-blind, placebo-controlled studies of TBR-652 in eighty-four healthy volunteers.

12 Nov 2009

FDA approves CSL Biotherapies' seasonal flu vaccine, Afluria for children

CSL Biotherapies, a subsidiary of CSL Limited, one of the world’s leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s application for accelerated approval of its seasonal flu vaccine, Afluria® (Influenza Virus Vaccine) for use in the pediatric population aged 6 months and older.

12 Nov 2009

Data on Alexion Pharmaceuticals' Soliris to be presented at the ASH meeting

Alexion Pharmaceuticals, Inc. today announced that researchers are scheduled to present data relating to Soliris® (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) during the 51st Annual Meeting of the American Society of Hematology (ASH), to be held December 5 – 8, 2009 at the Ernst N. Morial Convention Center in New Orleans.

11 Nov 2009

Prostatitis is a psychoneuromuscular condition: Study

In the November 2009 issue of the Journal of Urology, Stanford Medical School researcher Dr. Rodney Anderson and researchers at the National Center for Pelvic Pain Research, in a new study, demonstrated a high correlation between the location of painful trigger points inside the pelvic floor muscles of men with chronic prostatitis and the location in the body where they routinely complain of pain.

10 Nov 2009