Headache News and Research

Latest Headache News and Research

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.

29 Dec 2010

Hangover tips for the festive season!

A bad hangover usually comes with a variety of symptoms like headaches, fatigue, upset stomach, sweating, nausea, bad taste in the mouth excessive thirst, sensitivity to light etc. This is mainly due to the diuretic effects of alcohol that leaves one dehydrated.

28 Dec 2010

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

Cephalon, Inc. today announced that the company received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV] for the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA.

28 Dec 2010

MigreLief releases safe, proven effective supplement for children with migraines

MigreLief, the first name in migraine prevention, releases a safe and proven effective supplement for children of all ages: Children's MigreLief.

24 Dec 2010

Zogenix announces underwriters partial exercise of over-allotment option in initial public offering

Zogenix, Inc. announced today that the underwriters of its recently completed initial public offering of common stock have partially exercised their option to purchase shares of common stock from Zogenix to cover over-allotments. The sale of additional shares is expected to close on December 27, 2010.

23 Dec 2010

USAID official discusses agency's efforts to address cholera in Haiti

A USAID official said Tuesday that potential violence following the release of Haiti's final presidential election results could interfere with efforts to contain the country's cholera epidemic, CBC News reports. "What we all worry about is if there is violence again and it disrupts for a couple of days," said Mark Ward, acting director of USAID's Office of U.S. Foreign Disaster Assistance. "That's my biggest headache right now," he added.

23 Dec 2010

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.

23 Dec 2010

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

FDA approves Gardasil for prevention of anal cancer

The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

23 Dec 2010

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

23 Dec 2010

FDA joins Abbott Diabetes Careto to recall 359 glucose test strips

The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Both scenarios pose risks to a patient's health.

22 Dec 2010

Biogen Idec, Elan propose updated product labeling for TYSABRI to FDA and EMA

Biogen Idec and Elan Corporation, plc announced that the companies have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics.

22 Dec 2010

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), and duetact® (pioglitazone HCl and glimepiride).

22 Dec 2010

Chronic fatigue syndrome not linked to virus

The latest research from the University College London, the Wellcome Trust Sanger Institute, and University of Oxford, England suggests that chronic fatigue syndrome (CFS) is not caused by the virus XMRV (xenotropic murine leukemia virus-related virus). The team says that earlier research that linked the virus to CFS was faulty because of contamination of mouse cell DNA samples in the laboratory.

21 Dec 2010

Genentech confirms EMA, FDA updates on Avastin for metastatic breast cancer

Genentech, a member of the Roche Group, confirmed that following the reviews of Avastin® (bevacizumab) in metastatic breast cancer by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), the following regulatory announcements were made by the individual health authorities:

17 Dec 2010

Bayer's SAFYRAL oral contraceptive receives FDA approval

Bayer HealthCare Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive (OC), SAFYRAL™ (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets). In women who choose an OC for birth control, SAFYRAL raises folate levels for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking SAFYRAL or shortly after discontinuing it.

17 Dec 2010

GTx announces Capesaris proof of concept clinical trail in men with advanced prostate cancer

BETHESDA, Md.,GTx, Inc. this weekend presented results of the Capesaris™ (GTx-758) proof of concept pharmacokinetic-pharmacodynamic (PK/PD) clinical trial at the Annual Meeting of the Society of Urologic Oncology.

14 Dec 2010

Top-line results from Inhibitex's FV-100 Phase II clinical trial for treatment of shingles

Inhibitex, Inc. today reported top-line safety and efficacy data from its Phase II clinical trial of FV-100, an oral antiviral compound being developed to treat herpes zoster, more commonly referred to as shingles. The study was the first clinical trial to assess the antiviral activity of FV-100, included 350 shingles patients and compared two once-daily doses of FV-100 (200 mg and 400 mg) to an active control, valacyclovir, one of the most commonly-used antiviral drugs to treat shingles.

14 Dec 2010

Zogenix's SUMAVEL DosePro Needle-free Delivery System wins 2010 Most Innovative Product award

Zogenix, Inc. today announced that CONNECT, a regional San Diego nonprofit organization, selected SUMAVEL® DosePro™ (sumatriptan injection) Needle-free Delivery System as a 2010 Most Innovative Product (MIP) winner at the MIP Awards Luncheon on December 10, 2010.

13 Dec 2010

Talecris initiates clinical trial to evaluate 2 doses of PROLASTIN-C for emphysema due to AAT deficiency

Talecris Biotherapeutics, Inc. announced today the initiation of a clinical trial evaluating the safety and the pharmacokinetic profile of two doses of PROLASTIN®-C (Alpha(1)-Proteinase Inhibitor [Human]) (A1PI), a therapy indicated for chronic augmentation and maintenance in adults with emphysema due to alpha(1)-antitrypsin (AAT) deficiency. AAT deficiency is a rare, genetic disorder in which low levels of the alpha(1) protein circulating in the lungs can increase an individual's risk of developing emphysema.

10 Dec 2010

Headache News and Research

Latest Headache News and Research

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

Hangover tips for the festive season!

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

MigreLief releases safe, proven effective supplement for children with migraines

Zogenix announces underwriters partial exercise of over-allotment option in initial public offering

USAID official discusses agency's efforts to address cholera in Haiti

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

FDA approves Gardasil for prevention of anal cancer

FDA approves Novartis' Amturnide for treatment of high blood pressure

FDA joins Abbott Diabetes Careto to recall 359 glucose test strips

Biogen Idec, Elan propose updated product labeling for TYSABRI to FDA and EMA

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Chronic fatigue syndrome not linked to virus

Genentech confirms EMA, FDA updates on Avastin for metastatic breast cancer

Bayer's SAFYRAL oral contraceptive receives FDA approval

GTx announces Capesaris proof of concept clinical trail in men with advanced prostate cancer

Top-line results from Inhibitex's FV-100 Phase II clinical trial for treatment of shingles

Zogenix's SUMAVEL DosePro Needle-free Delivery System wins 2010 Most Innovative Product award

Talecris initiates clinical trial to evaluate 2 doses of PROLASTIN-C for emphysema due to AAT deficiency

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

Headache News and Research

Latest Headache News and Research

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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