Headache News and Research

Latest Headache News and Research

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

Baxter International, DVC present Phase III clinical efficacy data for PREFLUCEL

Baxter International Inc., in conjunction with DynPort Vaccine Company LLC, a CSC Company, today presented Phase III study data measuring the clinical efficacy for PREFLUCEL, a trivalent seasonal influenza candidate vaccine. PREFLUCEL is made using Baxter’s Vero cell culture platform and does not contain an adjuvant or preservatives. The data were presented at the International Congress on Infectious Disease (ICID) in Miami, Florida.

From Baxter International Inc. 12 Mar 2010

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

Watson Pharmaceuticals, Inc., today announced the U.S. Food and Drug Administration approval of TRELSTAR® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTAR®, a proven, simple and effective palliative treatment of advanced prostate cancer.

11 Mar 2010

Injured nerves may cause severe pain in patients with sickle cell disease

Researchers at the University of Illinois at Chicago have discovered the pain caused by sickle cell disease may not occur solely from damaged tissues, but also from injured nerves.

11 Mar 2010

Bristol-Myers Squibb, AstraZeneca commence SAVOR-TIMI 53 trial of ONGLYZA for type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial, a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors.

10 Mar 2010

FDA approves BOTOX for treatment of increased muscle stiffness in adults with upper limb spasticity

Allergan, Inc. today announced that the United States Food and Drug Administration has approved BOTOX® (onabotulinumtoxinA) for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity.

9 Mar 2010

Orexigen Therapeutics reports net loss of $15.0M for three months ended December 31, 2009

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the three months and year ended December 31, 2009.

9 Mar 2010

Data evaluating safety, efficacy of STELARA and REMICADE in patients with plaque psoriasis to be presented

Data evaluating the efficacy and safety of STELARA™ (ustekinumab) and REMICADE® (infliximab) in patients with plaque psoriasis who had an inadequate response to Enbrel® (etanercept) will be presented at the 68th Annual Meeting of the American Academy of Dermatology (AAD) in Miami, Fla., from March 5-9, 2010.

5 Mar 2010

FDA approves CSL Behring's Hizentra for PI

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for HizentraTM, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI). A once weekly immunoglobulin (Ig) replacement therapy, Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body.

4 Mar 2010

Columbia Laboratories to sell progesterone related assets and 11.2M shares to Watson Pharmaceuticals

Columbia Laboratories, Inc. has entered into a definitive agreement to sell substantially all of its progesterone related assets and 11.2 million shares of common stock to Watson Pharmaceuticals, Inc. for a $47 million upfront payment plus royalties of 10 to 20 percent of annual net sales of certain progesterone products. Additional payments up to $45.5 million can be earned by the successful completion of clinical development milestones in the ongoing PREGNANT Study, regulatory filings, receipt of regulatory approvals and product launches.

4 Mar 2010

Watson Pharmaceuticals to acquire U.S. rights to Columbia's bioadhesive progesterone gel products

Watson Pharmaceuticals, Inc. today announced an agreement to expand their Women's Health brand product portfolio with the acquisition of the exclusive U.S. rights to Columbia Laboratories, Inc.'s bioadhesive progesterone gel products currently marketed under the trade names CRINONE® and PROCHIEVE® for the indications of infertility and secondary amenorrhea.

4 Mar 2010

Allergan celebrates 20th anniversary of BOTOX in Canada

Twenty years ago, the first approved use of BOTOX(R) (botulinum toxin type A), a neurotoxin widely used to treat several life altering medical conditions, was granted in Canada. As part of the 20th anniversary celebrations, healthcare professionals from coast to coast reflect upon the discovery, science and evolution of a therapy that has impacted the lives of millions of patients worldwide.

3 Mar 2010

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Data from two Phase III studies of Merck’s investigational fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) were presented by researchers today in two poster presentations at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

3 Mar 2010

Data demonstrating effectiveness of KALBITOR to treat acute HAE presented at AAAAI 2010 Annual Meeting

Data demonstrating the effectiveness of KALBITOR (ecallantide) to treat hereditary angioedema (HAE) acute attacks by primary attack location were provided in an oral presentation yesterday at the American Academy of Allergy, Asthma and Immunology 2010 Annual Meeting in New Orleans.

3 Mar 2010

Headache News and Research

Latest Headache News and Research

Genentech submits ACTEMRA sBLA to FDA

NDA for BYDUREON: FDA issues complete response letter

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

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

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

Genentech announces topline results from Phase III trial of Avastin

Traumatic brain injuries may lead to life-threatening complications

Baxter International, DVC present Phase III clinical efficacy data for PREFLUCEL

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

Injured nerves may cause severe pain in patients with sickle cell disease

Bristol-Myers Squibb, AstraZeneca commence SAVOR-TIMI 53 trial of ONGLYZA for type 2 diabetes

FDA approves BOTOX for treatment of increased muscle stiffness in adults with upper limb spasticity

Orexigen Therapeutics reports net loss of $15.0M for three months ended December 31, 2009

Data evaluating safety, efficacy of STELARA and REMICADE in patients with plaque psoriasis to be presented

FDA approves CSL Behring's Hizentra for PI

Columbia Laboratories to sell progesterone related assets and 11.2M shares to Watson Pharmaceuticals

Watson Pharmaceuticals to acquire U.S. rights to Columbia's bioadhesive progesterone gel products

Allergan celebrates 20th anniversary of BOTOX in Canada

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Data demonstrating effectiveness of KALBITOR to treat acute HAE presented at AAAAI 2010 Annual Meeting

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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