Headache News and Research

Latest Headache News and Research

Lysteda tablets to treat menorrhagia approved by the FDA

The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

24 Nov 2009

Health debate bears down on senators

"As one of the few senators undecided on healthcare reform, Arkansas Democrat Blanche Lincoln faces a huge headache. Liberals attack her as an obstructionist, even though she cast a key vote keeping the effort alive. Republicans are lining up to run against her -- seven, so far, and counting. The voters here at home seem conflicted, if not downright confused.

23 Nov 2009

First Edition: November 23, 2009

Today's headlines indicate that even after Senate Majority Leader Harry Reid found victory Saturday night with the first health bill test vote, his measure is likely to be the subject of an even more intense debate as the measure moves forward.

23 Nov 2009

Evidence does not connect H1N1 vaccine to patient deaths, WHO says

The deaths of 41 people from six countries who had received the H1N1 (swine flu) vaccine were not directly linked to the vaccine, the WHO said Thursday, the Associated Press/MSNBC reports (11/19).

20 Nov 2009

Pfizer’s Revatio Injection receives FDA approval

Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.

20 Nov 2009

EMEA's CHMP recommends approval of Merck's ELONVA

Merck & Co., Inc. today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA® (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.

20 Nov 2009

FDA issues complete response for Rituxan, a drug for treating chronic lymphocytic leukemia

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies’ applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL).

19 Nov 2009

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