Headache News and Research

Latest Headache News and Research

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

Genentech submits ACTEMRA sBLA to FDA

Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for ACTEMRA® (tocilizumab) for the prevention of structural joint damage (as assessed by radiograph) and improvement in physical function in adults with moderately to severely active rheumatoid arthritis (RA).

17 Mar 2010

NDA for BYDUREON: FDA issues complete response letter

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for BYDUREON™ (exenatide for extended-release injectable suspension).

15 Mar 2010

Post-marketing safety studies for LABAs: AstraZeneca confident of SYMBICORT in treatment of asthma

On March 10-11, 2010, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) -- including the Pulmonary-Allergy Drugs and the Drug Safety and Risk Management Advisory Committees -- discussed the design of post-marketing safety studies for long-acting beta-agonist (LABA)-containing products in the U.S., including SYMBICORT® (budesonide/formoterol fumarate dihydrate).

12 Mar 2010

AED Vimpat demonstrates fewer partial-onset seizures in adults with epilepsy

UCB today announced that the antiepileptic drug (AED) Vimpat- (lacosamide) (C-V) demonstrated significantly fewer partial-onset seizures versus placebo in adults living with epilepsy, according to a Phase III clinical study published online in Epilepsia.

12 Mar 2010

Phase III clinical study: Vimpat demonstrates fewer partial-onset seizures versus placebo in adults with epilepsy

UCB today announced that the antiepileptic drug (AED) Vimpat® (lacosamide) (C-V) demonstrated significantly fewer partial-onset seizures versus placebo in adults living with epilepsy, according to a Phase III clinical study published online in Epilepsia.

12 Mar 2010

Genentech announces topline results from Phase III trial of Avastin

Genentech, Inc., a wholly owned member of the Roche Group, announced today the topline results of a Phase III trial led by the U.S. Cancer and Leukemia Group B (CALGB) and sponsored by the National Cancer Institute investigating the use of Avastin® (bevacizumab) in combination with docetaxel chemotherapy and prednisone in men with late stage prostate cancer (hormone-refractory / HRPC).

12 Mar 2010

Traumatic brain injuries may lead to life-threatening complications

One of the most common questions I am asked after someone hits their head is, "How serious is this bump on my head and should I make an appointment?" Head injuries are the result of trauma to the scalp, skull or brain. Concussion, the most common type of traumatic brain injury (TBI), is an injury that occurs after a blow to the head and results in a temporary loss of consciousness.

12 Mar 2010