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.

Gastrointestinal tract disorders GERD and IBS interlinked

Gastroesophageal reflux disorder (GERD) and irritable bowel syndrome (IBS) are two very common disorders affecting the gastrointestinal tract. About 10% of the population experience daily discomfort from reflux of gastric contents into the esophagus. More than 10% of the population experience abdominal pain and disturbed bowel movement because of irritable bowel syndrome.

2 Apr 2010

UK NICE recommends Eli Lilly's ALIMTA as maintenance therapy for nonsquamous NSCLC

Eli Lilly and Company announced today that its chemotherapy ALIMTA® (pemetrexed for injection) received a positive "Final Appraisal Determination" from the United Kingdom's National Institute for Health and Clinical Excellence (NICE).

2 Apr 2010

AMAG Pharmaceuticals, Takeda Pharmaceutical announce Feraheme collaboration

AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today jointly announced that the companies have entered into a license, development and commercialization agreement related to Feraheme® (ferumoxytol) Injection for intravenous (IV) use in all therapeutic indications.

1 Apr 2010

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc. announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.

1 Apr 2010

Eisai Europe seeks EMA approval of eribulin mesylate for locally advanced or metastatic breast cancer

Eisai Europe Ltd. today announced that it has submitted a marketing authorization application to the European Medicines Agency (EMA) for approval of eribulin mesylate, also known as 'E7389', for the treatment of locally advanced or metastatic breast cancer in Europe. Eribulin mesylate, a non-taxane microtubule dynamics inhibitor, is an investigational chemical compound discovered and developed by Eisai. Regulatory applications for eribulin mesylate have also been submitted in the United States and Japan.

31 Mar 2010

Eisai seeks simultaneous approval of eribulin mesylate in U.S., EU and Japan

Eisai Inc. today announced that it has submitted simultaneous regulatory applications for approval of eribulin mesylate (also known as E7389) for the treatment of locally advanced or metastatic breast cancer to agencies in Japan, the United States and the European Union (EU). Eribulin, a non-taxane microtubule dynamics inhibitor, is an investigational chemical compound discovered and developed by Eisai.

31 Mar 2010

Patients switching to Victoza experience further reductions in A1c and weight loss

Diabetes Care published online the results of the Novo Nordisk LEAD™ 6 extension study, which evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza®. Results show that when added to oral antidiabetes drugs, patients who switched from exenatide to Victoza experienced further reductions in A1c and weight loss.

31 Mar 2010

NICE appraisal committee publishes preliminary recommendation of Multaq for AF

Sanofi-aventis announced today that the National Institute for Health and Clinical Excellence (NICE) in England and Wales, has just published a new appraisal consultation document for Multaq(R) (dronedarone) indicating its intention to recommend Multaq(R) use for the management of patients with atrial fibrillation.

30 Mar 2010

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

Pacemaker in stomach can help treat severe stomach disorders and chronic vomiting

People with severe stomach disorders can sometimes suffer from chronic vomiting. This symptom can be treated with electrical impulses from a pacemaker in the stomach. A new method enables patients who could benefit from this treatment to be identified, and electrical stimulation leads to reduced nausea and fewer days in hospital, shows a study from the Sahlgrenska Academy at the University of Gothenburg, Sweden.

29 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

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

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

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

American Association of Poison Control Centers: K2 herbal marijuana substitute spurred poison calls

K2, an herbal marijuana substitute also known as "spice," is a blend of herbs sprayed with a synthetic marijuana-like drug, and has spurred at least 112 calls to U.S. poison centers since 2009, including 59 calls since March 1, 2010.

25 Mar 2010

Research could pave way for new generation of painkillers

An international group of scientists led by Dr Nikita Gamper of the University's Faculty of Biological Sciences has discovered how two proteins play a key role in the way we feel pain, offering new targets on which drug development can be focused.

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

Bioalliance Pharma's anti-emetic drug Setofilm receives European approval

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced approval for Setofilm® in 16 European countries.

24 Mar 2010

Clinical Data completes NDA submission for vilazodone

Clinical Data, Inc., today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vilazodone for the treatment of major depressive disorder (MDD). Vilazodone is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. The Company expects that the NDA submission, if accepted, will be subject to a standard review.

23 Mar 2010

Nausea News and Research

Further Reading

Gastrointestinal tract disorders GERD and IBS interlinked

UK NICE recommends Eli Lilly's ALIMTA as maintenance therapy for nonsquamous NSCLC

AMAG Pharmaceuticals, Takeda Pharmaceutical announce Feraheme collaboration

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Eisai Europe seeks EMA approval of eribulin mesylate for locally advanced or metastatic breast cancer

Eisai seeks simultaneous approval of eribulin mesylate in U.S., EU and Japan

Patients switching to Victoza experience further reductions in A1c and weight loss

NICE appraisal committee publishes preliminary recommendation of Multaq for AF

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

Pacemaker in stomach can help treat severe stomach disorders and chronic vomiting

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

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

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

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

American Association of Poison Control Centers: K2 herbal marijuana substitute spurred poison calls

Research could pave way for new generation of painkillers

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Xifaxan drug receives FDA approval

Bioalliance Pharma's anti-emetic drug Setofilm receives European approval

Clinical Data completes NDA submission for vilazodone

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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