Nausea News and Research

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Nausea is the sensation of unease and discomfort in the upper stomach and head with an urge to vomit. An attack of nausea is known as a qualm.

Ready-to-Use Cardene I.V. lowers acutely elevated blood pressure: CLUE study

Results from the CLUE study, a head-to-head comparison between Ready-to-Use Cardene I.V. (nicardipine) and labetalol in the emergency room, showed that Ready-to-Use Cardene I.V. lowers acutely elevated blood pressure more effectively than labetalol. These data were presented today at the annual meeting of the American College of Emergency Physicians (ACEP) in Las Vegas, Nevada.

29 Sep 2010

Intrauterine devices for treatment of endometrial cancer

Intrauterine devices, originally developed as contraceptives, can also be used to treat and cure cancer of the endometrium according to new research published online in the cancer journal, Annals of Oncology today (Wednesday 29 September). The finding opens the way for young women with the disease, which affects the lining of the womb, to be treated without the need for a hysterectomy, thus preserving their fertility until they have had all the children they want.

29 Sep 2010

Further trials needed to determine clinical application of Abatacept in SLE

Results from a 12-month multi-center clinical trial did not show therapeutic benefit of abatacept over placebo in patients with non-life threatening systemic lupus erythematosus (SLE). Abatacept failed to prevent new disease flares in SLE patients tapered from corticosteroids in an analysis where mild, moderate and severe disease flares were evaluated together. Full details of the phase IIb clinical trial are published in the October issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology (ACR).

29 Sep 2010

PGIC analysis indicates tapentadol ER tablets provide significant improvement in pain intensity

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic low back pain have been published online by Expert Opinion on Pharmacotherapy. In addition, this study compared oxycodone controlled-release (CR) to placebo as an active control.

28 Sep 2010

Bayer’s new oral contraceptive receives FDA approval

Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration has approved a new oral contraceptive, Beyaz (drospirenone / ethinyl estradiol / levomefolate calcium tablets and levomefolate calcium tablets).

28 Sep 2010

Pfizer ceases SUN 1120 Phase 3 trial of SUTENT in men with CRPC

Pfizer Inc. announced today the discontinuation of the SUN 1120 Phase 3 trial evaluating SUTENT (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer that had progressed despite treatment with a docetaxel-based chemotherapy regimen. During a scheduled interim analysis, an independent Data Monitoring Committee found that the combination of sunitinib with prednisone was unlikely to improve overall survival when compared to prednisone alone.

28 Sep 2010

Scientists identify gene associated with common migraines

An international study led by scientists at Universit- de Montr-al and University of Oxford, has identified a gene associated with common migraines. Their findings show that a mutation in the KCNK18 gene inhibits the function of a protein called TRESK. TRESK normally plays a key role in nerve cell communication. Published today in Nature Medicine, this study may have implications for people who suffer from recurrent headaches, which include more than six million Canadians.

28 Sep 2010

FDA approves Beyaz tablets to increase folate level in women

The U.S. Food and Drug Administration today approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).

27 Sep 2010

Astellas Pharma announces Phase IV study results of Lexiscan injection at ASNC session

Today Astellas Pharma US, Inc. announced results of a Phase IV study showing Lexiscan(regadenoson) Injection was comparable to placebo in causing a >15% decrease in forced expiratory volume in one second (FEV1) in subjects with asthma or chronic obstructive pulmonary disease (COPD) who are likely candidates for myocardial perfusion imaging (MPI) studies.

27 Sep 2010

Takeda underscores commitment to ACTOS following FDA and EMA announcements for rosiglitazone

Following today’s announcements by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for rosiglitazone in the U.S. and Europe, Takeda Pharmaceuticals North America, Inc. and Takeda Pharmaceuticals Europe Limited underscore the company’s commitment to ACTOS® (pioglitazone HCl) and ACTOS-containing medications, and to the millions of people living with type 2 diabetes.

24 Sep 2010

Linagliptin clinical trial data shows positive result for type 2 diabetes treatment

New data from the linagliptin late stage clinical trial programme were presented this week at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD).

23 Sep 2010

FDA and EMA accept regulatory submissions of vandetanib for advanced medullary thyroid cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the investigational drug vandetanib in the treatment of patients with advanced medullary thyroid cancer (MTC). The FDA also granted priority review status for the new drug application and set a Prescription Drug User Fee Act (PDUFA) action date of 7 January 2011.

23 Sep 2010

FDA approves Roche's COBAS AmpliPrep / COBAS TaqMan HBV Test v2.0

Roche Molecular Diagnostics announced today that the U.S. Food & Drug Administration (FDA) has approved the COBAS® AmpliPrep / COBAS® TaqMan® HBV Test v2.0 for use in the United States. The new Roche test provides a fully automated solution for the quantitative detection of hepatitis B virus (HBV) DNA in human plasma or serum for patients on HBV antiviral therapy.

23 Sep 2010

Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

Biogen Idec is committed to improving the lives of people with multiple sclerosis (MS), and no company is doing more for these patients. There has been a desire within the MS community for an oral treatment for a long time, and the approval of Gilenya has made this a reality.

23 Sep 2010

Intarcia Therapeutics presents ITCA 650 phase 2 study results for type 2 diabetes

Intarcia Therapeutics, Inc. presented today final results of a 24-week phase 2 clinical study of ITCA 650 (DUROS continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes at the 46th Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden.

23 Sep 2010

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Progenics Pharmaceuticals, Inc. today announced the completion of the treatment phase of a 1,034-patient, one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation (OIC).

22 Sep 2010

Novartis' SOM230 reduces cortisol levels in Cushing's disease patients

Novartis Pharmaceuticals Corporation announced today that the results of a Phase III study of SOM230 (pasireotide) showed a reduction in cortisol levels in patients with Cushing's disease, a condition in which a benign (non-cancerous) pituitary tumor causes the adrenal glands to produce excess cortisol and can be fatal. Results will be presented at the 14th Congress of the European Neuroendocrine Association (ENEA).

22 Sep 2010

FDA grants Phadia 510(k) clearance for CLIA Moderate Complexity, EliA autoimmune antibody assays

Today Phadia announced that it has received FDA 510(k) clearance for two new, CLIA Moderate Complexity, EliA autoimmune antibody assays. The new assays will provide physicians with additional tools needed to aid in the diagnosis of Celiac disease. The newly available assays, EliA GliadinDP IgA and EliA GliadinDP IgG (deamidated peptides), have proven to be essential, sensitive and specific markers to aid in the diagnosis of celiac disease.

22 Sep 2010

High dose aspirin effective for treatment of severe headache and migraine

An inexpensive, hundred-year-old therapy for pain - aspirin - is effective in high doses for the treatment of severe headache and migraine caused by drug withdrawal, according to a new study by researchers with the UCSF Headache Center. Study participants were administered aspirin through an IV and 25 percent of the time they reported a significant reduction in pain - three points on the 10-point pain scale.

22 Sep 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010

Nausea News and Research

Further Reading

Ready-to-Use Cardene I.V. lowers acutely elevated blood pressure: CLUE study

Intrauterine devices for treatment of endometrial cancer

Further trials needed to determine clinical application of Abatacept in SLE

PGIC analysis indicates tapentadol ER tablets provide significant improvement in pain intensity

Bayer’s new oral contraceptive receives FDA approval

Pfizer ceases SUN 1120 Phase 3 trial of SUTENT in men with CRPC

Scientists identify gene associated with common migraines

FDA approves Beyaz tablets to increase folate level in women

Astellas Pharma announces Phase IV study results of Lexiscan injection at ASNC session

Takeda underscores commitment to ACTOS following FDA and EMA announcements for rosiglitazone

Linagliptin clinical trial data shows positive result for type 2 diabetes treatment

FDA and EMA accept regulatory submissions of vandetanib for advanced medullary thyroid cancer

FDA approves Roche's COBAS AmpliPrep / COBAS TaqMan HBV Test v2.0

Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

Intarcia Therapeutics presents ITCA 650 phase 2 study results for type 2 diabetes

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Novartis' SOM230 reduces cortisol levels in Cushing's disease patients

FDA grants Phadia 510(k) clearance for CLIA Moderate Complexity, EliA autoimmune antibody assays

High dose aspirin effective for treatment of severe headache and migraine

Annals of Internal Medicine publishes GRACE study data on HIV therapy

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