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.

Shire receives European marketing approval for VPRIV therapy to treat type 1 Gaucher disease

Shire, the global specialty biopharmaceutical company, announced today that the European Commission has granted marketing authorisation for VPRIV(R) (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease.

27 Aug 2010

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.

27 Aug 2010

PLX4032 therapy results in tumor shrinkage in metastatic melanoma patients

A multicenter study has concluded that treatment with a new targeted therapy called PLX4032 (also called RG7204) resulted in significant tumor shrinkage in 80 percent of patients with advanced melanoma.

26 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Tranzyme Pharma to present ulimorelin Phase 2 data at NGM Meeting

Tranzyme Pharma announced today that John Wo, MD, Professor of Medicine, Director, Clinical Research, Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, will present ulimorelin Phase 2 data at this year's Joint International NGM Meeting on Saturday, August 28, 2010.

25 Aug 2010

BioAlliance Pharma launches Oravig drug in the U.S. market

BioAlliance Pharma SA, a company dedicated to the supportive care and treatment of cancer patients, today announces the launch in the United States of Oravig® (known as Loramyc® in Europe) for the treatment of oropharyngeal candidiasis (OPC) in adults by its commercial partner, Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc..

25 Aug 2010

Scientists develop nano-sized vehicle to deliver chemotherapy drugs directly into cancer cells

Chemotherapy, while an effective cancer treatment, also brings debilitating side effects such as nausea, liver toxicity and a battered immune system.Now, a new way to deliver this life-saving therapy to cancer patients getting straight to the source of the disease.

24 Aug 2010

Pfizer reports Progression-Free survival in SUN 1087 combination trial of sunitinib with erlotinib for NSCLC

Pfizer Inc. announced today that the SUN 1087 trial of sunitinib in combination with erlotinib versus erlotinib demonstrated a statistically significant improvement in Progression-Free but not in Overall Survival in patients with previously treated advanced non-small cell lung cancer (NSCLC).

24 Aug 2010

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Genzyme Corporation announced today that the two-year follow-up results from the phase 2 clinical trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood. The results have been pre-published on the journal's website and are available to subscribers.

23 Aug 2010

Novo Nordisk reaches exclusive agreement to market Vagifem 10 mcg

Novo Nordisk Inc. today announced that it has signed an exclusive agreement with Upsher-Smith Laboratories, Inc. to market Vagifem (estradiol vaginal tablets) 10 mcg. Under the terms of the agreement, Upsher-Smith will exclusively market Vagifem 10 mcg to physicians in the U.S. beginning August 2 through the company's existing field sales force.

23 Aug 2010

FDA approves Alexion's Rhode Island manufacturing facility as commercial supply source for Soliris

Alexion Pharmaceuticals, Inc. today announced that the US Food and Drug Administration (FDA) has approved Alexion's Rhode Island manufacturing facility (ARIMF) in Smithfield, Rhode Island as a second source of commercial supply for Soliris® (eculizumab).

23 Aug 2010

Hillandale Farms of Iowa voluntarily recalls shell eggs

Hillandale Farms of Iowa is voluntarily recalling shell eggs because they have the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.

21 Aug 2010

FDA issues update to nationwide Salmonella infected egg recall

Through tracebacks conducted as part of its ongoing investigation into the increase of Salmonella Enteritidis illnesses nationwide, FDA and the State of Minnesota identified Hillandale Farms in Iowa as a second potential source of contaminated shell eggs.

21 Aug 2010

FDA releases statement on urgent nationwide egg recall

Working closely with the Centers for Disease Control and Prevention (CDC) and state public health partners, the FDA reviewed epidemiologic and environmental investigation documents and identified 3 best-case clusters of Salmonella Enteritidis illnesses. Tracebacks revealed Wright County Egg in Iowa as the common shell egg supplier in these clusters.

20 Aug 2010

Research on gut mucosa enables effective drug treatment for irritable bowel syndrome

Irritable bowel syndrome makes life miserable for those affected an estimated ten percent or more of the population. And what irritates many of them even more is that they often are labeled as hypochondriacs, since physical causes for irritable bowel syndrome have never been identified. Now, biologists at the Technische Universitaet Muenchen (TUM) have shed new light on the matter: They have discovered mini-inflammations in the mucosa of the gut, which upset the sensitive balance of the bowel and are accompanied by sensitization of the enteric nervous system.

20 Aug 2010

Palliative care recipients live longer and in less pain, study finds

The New York Times: "In a study that sheds new light on the effects of end-of-life care, doctors have found that patients with terminal lung cancer who began receiving palliative care immediately upon diagnosis not only were happier, more mobile and in less pain as the end neared — but they also lived nearly three months longer.

20 Aug 2010

FDA Advisory Committee votes in favor of expanding pain indications for Eli Lilly's Cymbalta

The U.S. Food and Drug Administration (FDA) Anesthetic and Life Support Drugs Advisory Committee voted 8-6 in favor of expanding the pain indications for Eli Lilly and Company's (NYSE: LLY) Cymbalta® (duloxetine HCl) to a broader pain population that will be further defined by the FDA, if approved.

20 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

Study quantifies risk for gastrointestinal illness due to E. coli bacteria at inland beach

New research shows a clear link between increasing levels of E. coli bacteria in an inland Ohio lake and a greater risk that swimmers in the water will suffer a gastrointestinal illness.

19 Aug 2010

Biogen Idec, Knopp Neurosciences enter license agreement for KNS-760704 ALS drug candidate

Biogen Idec and Knopp Neurosciences today announced they have entered into an exclusive, worldwide license agreement under which Biogen Idec will develop and commercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, and potentially other indications.

18 Aug 2010

Nausea News and Research

Further Reading

Shire receives European marketing approval for VPRIV therapy to treat type 1 Gaucher disease

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

PLX4032 therapy results in tumor shrinkage in metastatic melanoma patients

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Tranzyme Pharma to present ulimorelin Phase 2 data at NGM Meeting

BioAlliance Pharma launches Oravig drug in the U.S. market

Scientists develop nano-sized vehicle to deliver chemotherapy drugs directly into cancer cells

Pfizer reports Progression-Free survival in SUN 1087 combination trial of sunitinib with erlotinib for NSCLC

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Novo Nordisk reaches exclusive agreement to market Vagifem 10 mcg

FDA approves Alexion's Rhode Island manufacturing facility as commercial supply source for Soliris

Hillandale Farms of Iowa voluntarily recalls shell eggs

FDA issues update to nationwide Salmonella infected egg recall

FDA releases statement on urgent nationwide egg recall

Research on gut mucosa enables effective drug treatment for irritable bowel syndrome

Palliative care recipients live longer and in less pain, study finds

FDA Advisory Committee votes in favor of expanding pain indications for Eli Lilly's Cymbalta

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Study quantifies risk for gastrointestinal illness due to E. coli bacteria at inland beach

Biogen Idec, Knopp Neurosciences enter license agreement for KNS-760704 ALS drug candidate

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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