Headache News and Research

Latest Headache News and Research

Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

Genentech, Inc., a wholly-owned member of the Roche Group, today announced two-year results from a Phase III study, which showed that people with rheumatoid arthritis (RA) who received either a 4 mg/kg or 8 mg/kg dose of ACTEMRA® (tocilizumab), in combination with methotrexate, had no progression of joint damage, (75 and 83 percent, respectively, as assessed by radiograph) compared with people who received methotrexate alone (66 percent).

19 Oct 2009

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

19 Oct 2009

Rituxan's sBLA receives a Complete Response from the FDA

Genentech, Inc. a wholly-owned member of the Roche Group, and Biogen Idec announced today that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX.

19 Oct 2009

FDA grants marketing approval for Elitek

Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

19 Oct 2009

Migraine can stimulate alcohol-induced headache

Migraine sufferers, beware. You may be more prone to an alcohol-induced headache after a night of drinking, according to researchers from the Jefferson Headache Center.

19 Oct 2009

FDA approves Gardasil vaccine usage in boys and men for preventing genital warts

The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

19 Oct 2009

CVS Caremark's seasonal flu shot clinics to run through October 22

CVS/pharmacy announced today that its seasonal flu shot clinics will run through October 22, in light of manufacturer delays in delivery of seasonal flu vaccine affecting all health care providers. However, MinuteClinic will continue to administer seasonal flu vaccines at its 500 locations in 25 states throughout the flu season with the supply of vaccine replenished as frequently as possible.

19 Oct 2009

GlaxoSmithKline receives FDA approval for cervical cancer vaccine

GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

19 Oct 2009

Study shows type 2 diabetes patients treated with ACTOplus met experience blood sugar reduction

A study, published online in the journal Current Medical Research and Opinion, showed that a greater percentage of patients with type 2 diabetes treated with the fixed-dose combination ACTOplus met® (pioglitazone HCl and metformin HCl) as initial therapy reached the study goal of hemoglobin A1c (HbA1c) of less than or equal to 7 percent compared to either component alone.

15 Oct 2009

AVANIR Pharmaceuticals announces results of Zenvia double-blind Phase III STAR trial

AVANIR Pharmaceuticals, Inc. today announced detailed results from the confirmatory double-blind Phase III STAR trial evaluating two doses of the investigational drug Zenvia™ (dextromethorphan/quinidine) compared to placebo in the treatment of pseudobulbar affect (PBA) in patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS).

14 Oct 2009

Meda Pharmaceuticals introduces Onsolis for treating breakthrough cancer pain

Meda Pharmaceuticals Inc. today announced the launch of Onsolis(TM)(fentanyl buccal soluble film) in the U.S. for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

13 Oct 2009

FDA grants marketing approval for CSL Behring's Berinert C1-Esterase Inhibitor

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Berinert® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE), a rare and serious genetic disorder, in adult and adolescent patients. Berinert is the first and only therapy approved for this indication in the U.S.

12 Oct 2009

FDA approves Berinert for the treatment of hereditary angioedema

The U.S. Food and Drug Administration today approved Berinert, the first treatment for acute abdominal attacks and facial swelling associated with a rare and potentially life-threatening genetic disease called hereditary angioedema (HAE).

12 Oct 2009

CREON Delayed-Release Capsules improves fat absorption in patients with Cystic Fibrosis

Solvay Pharmaceuticals, Inc. announced that Phase III data published in the Journal of Cystic Fibrosis showed that CREON® (pancrelipase) Delayed-Release Capsules, the most prescribed pancreatic enzyme replacement therapy (PERT) in the United States, significantly improves a key measure of fat absorption in patients with CF who suffer from exocrine pancreatic insufficiency (EPI).

9 Oct 2009

FDA Advisory Committee approves use of Selzentry tablets in combination with HIV therapy

Pfizer Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee voted (10 to 4) to recommend the approval of Selzentry (maraviroc) tablets for use in treatment-naïve adult patients with CCR5-tropic HIV-1 virus as part of combination therapy.

9 Oct 2009

FDA files complaint against Rel's Foods for selling adulterated food products

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop the company from manufacturing, producing, and selling adulterated food products.

9 Oct 2009

BioDelivery Sciences' partner Meda to launch ONSOLIS for managing breakthrough pain

BioDelivery Sciences International, Inc. announced that its commercial partner Meda will launch the FDA-approved ONSOLIS (fentanyl buccal soluble film) next week for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

8 Oct 2009

APP Pharmaceuticals receives FDA approval to market Sumatriptan Succinate Injection

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Sumatriptan Succinate Injection, USP, in two dosage strengths.

8 Oct 2009

WHO emphasizes H1N1 vaccine safety

The WHO on Tuesday continued to express confidence in the H1N1 (swine flu) vaccine as few mild adverse effects have been reported by patients participating in China's vaccine campaign, the Associated Press reports. Out of the 39,000 people in China who received the H1N1 vaccine, four reported experiencing side effects such as muscle cramps and headache, according to WHO spokesman Gregory Hartl (Higgins, 10/6).

8 Oct 2009

FDA approves Daiichi Sankyo's sNDA for Welchol

Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy.

7 Oct 2009