Headache News and Research

Latest Headache News and Research

Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental new drug application

Cephalon, Inc. today announced the company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application for NUVIGIL® (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.

30 Mar 2010

Norovirus outbreak associated with oysters: FDA and Mississippi, Louisiana public health agencies issue warning

The U.S. Food and Drug Administration is working with state health officials from Mississippi and Louisiana to notify consumers, food service operators and retailers nationwide about an outbreak of norovirus associated with oysters recently harvested from an area near Port Sulphur, La. known as Area 7. The oysters were sold or distributed nationwide.

27 Mar 2010

FDA: Outbreak of campylobacteriosis linked to drinking raw milk

The U.S. Food and Drug Administration, along with several state agencies, is alerting consumers to an outbreak of campylobacteriosis associated with drinking raw milk. At least 12 confirmed illnesses have been recently reported in Michigan. Symptoms of campylobacteriosis include diarrhea, abdominal pain and fever.

27 Mar 2010

Medtronic announces enrollment of first European patients in randomized controlled trial of ITB Therapy

Medtronic, Inc. today announced the enrollment of the first European patients in the largest randomized controlled trial to date to investigate the benefits of ITB Therapy(R) (Intrathecal Baclofen) in post-stroke patients affected by spasticity. The announcement comes as the World Congress for Neurorehabilitation is taking place in Vienna, Austria.

26 Mar 2010

Researchers identify link between socioeconomic status and common disease symptoms

Researchers have identified the link between socioeconomic status and common symptoms of disease, prompting new questions about the causal connections between them.

26 Mar 2010

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Shire plc, the global specialty biopharmaceutical company, today presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase alfa for injection), from imiglucerase, as well as an interim analysis of safety data from an ongoing multicenter open-label treatment protocol (HGT-GCB-058) implemented to provide VPRIV to patients affected by the continuing shortage of imiglucerase.

26 Mar 2010

Mexican-American women les likely to use emergency medical services for stroke symptoms

Mexican Americans are 40 percent less likely than non-Hispanic whites to call 9-1-1 and be taken to the hospital via ambulance for stroke - resulting in medical treatment delays - according to a new study reported in Stroke: Journal of the American Heart Association.

26 Mar 2010

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved once-daily Mirapex ER® (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease, which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure.

26 Mar 2010

AVASTIN receives Health Canada approval for patients with GBM

Roche Canada announced today that Health Canada has approved AVASTIN(R) (bevacizumab), as a single agent, for the treatment of patients with glioblastoma multiforme, the most aggressive primary malignant brain tumour, after relapse or disease progression, following prior therapy.

26 Mar 2010

Biogen Idec and Elan begin comparative trial of MS treatments

Biogen Idec and Elan Corporation, plc (NYSE: ELN) today announced enrollment of the first patient in a global Phase IIIb, randomized, rater-blinded, active-controlled study designed to evaluate switching to TYSABRI® (natalizumab) from Copaxone® (glatiramer acetate) or Rebif® (interferon beta-1a) in patients with relapsing remitting multiple sclerosis.

25 Mar 2010

EMA accepts MAA filing of ViroPharma's Cinryze for HAE

ViroPharma Incorporated today announced that the European Medicines Agency (EMA) has accepted the filing of its Marketing Authorization Application for Cinryze for acute treatment and prophylaxis against hereditary angioedema, which was submitted through the centralized procedure in March 2010. ViroPharma is seeking European approval for both prevention and treatment of acute attacks of hereditary angioedema.

25 Mar 2010

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration has granted marketing approval for XIFAXAN 550 mg tablets for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments. This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.

25 Mar 2010

Xifaxan drug receives FDA approval

The U.S. Food and Drug Administration today approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease.

25 Mar 2010

Republicans rally around repeal effort

The Christian Science Monitor: "Sen. Jim DeMint of South Carolina is already set to introduce legislation repealing the legislation that President Obama will sign on Tuesday. Sen. John McCain (R) of Arizona, caught in a tough GOP primary battle for reelection, is arguing in a fundraising appeal that he should stay in the Senate to lead the fight for repeal."

24 Mar 2010

First Edition: March 23, 2010

Today's headlines cover a range of topics related to the newly passed health overhaul bill, from the surrounding opposition and next steps to some of its policy implications.

23 Mar 2010

LFA seeks grant proposals from researchers and investigators to help advance in lupus research

The Lupus Foundation of America seeks grant proposals from researchers and investigators to help advance the science and understanding of pediatric lupus, reproductive health issues in people with lupus, and neuropsychiatric lupus, which affects the brain and peripheral nervous system.

23 Mar 2010

Acorda Therapeutics submits applications to extend patent protection for AMPYRA to USPTO

Acorda Therapeutics, Inc. today announced that the Company has submitted applications to extend patent protection for AMPYRA™ (dalfampridine) Extended Release Tablets, 10 mg to the United States Patent and Trademark Office.

22 Mar 2010

ViroPharma to present Cinryze data at Southern European Allergy Society congress

ViroPharma Incorporated today announced the presentation of two abstracts relating to Cinryze™ (C1 esterase inhibitor [human]) therapy at the First International Congress of the Southern European Allergy Society in Florence, Italy.

19 Mar 2010

ViroPharma launches 'Ryze Above' for patients with HAE enrolled in CINRYZESolutions support program

ViroPharma Incorporated today announced the launch of 'Ryze Above' (www.ryzeabove.com), an exclusive patient resources program within the company's patient support program, CINRYZESolutions®. The Ryze Above program was created for HAE patients prescribed Cinryze, the first and only drug specifically approved to help prevent swelling and/or painful attacks in teenagers and adults with HAE.

19 Mar 2010

ONGLYZA-metformin combination: FDA accepts NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.

17 Mar 2010

Headache News and Research

Latest Headache News and Research

Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental new drug application

Norovirus outbreak associated with oysters: FDA and Mississippi, Louisiana public health agencies issue warning

FDA: Outbreak of campylobacteriosis linked to drinking raw milk

Medtronic announces enrollment of first European patients in randomized controlled trial of ITB Therapy

Researchers identify link between socioeconomic status and common disease symptoms

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Mexican-American women les likely to use emergency medical services for stroke symptoms

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

AVASTIN receives Health Canada approval for patients with GBM

Biogen Idec and Elan begin comparative trial of MS treatments

EMA accepts MAA filing of ViroPharma's Cinryze for HAE

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Xifaxan drug receives FDA approval

Republicans rally around repeal effort

First Edition: March 23, 2010

LFA seeks grant proposals from researchers and investigators to help advance in lupus research

Acorda Therapeutics submits applications to extend patent protection for AMPYRA to USPTO

ViroPharma to present Cinryze data at Southern European Allergy Society congress

ViroPharma launches 'Ryze Above' for patients with HAE enrolled in CINRYZESolutions support program

ONGLYZA-metformin combination: FDA accepts NDA for review

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

Headache News and Research

Latest Headache News and Research

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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