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.

FDA approves SUTENT for treatment of pancreatic NET

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SUTENT® (sunitinib malate) as the first anti-VEGF therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors (NET) in patients with unresectable locally advanced or metastatic disease. Pancreatic NET is a rare cancer reported in two to four people per million annually worldwide.

21 May 2011

Phase 3 open-label study of RELISTOR presented at American Pain Society meeting

Salix Pharmaceuticals, Ltd. today announced findings from two analyses of a Phase 3 open-label study of RELISTOR (methylnaltrexone bromide) presented at the 30th Annual Scientific Meeting of the American Pain Society. The meeting is being held in Austin, TX, on May 19-21, 2011.

21 May 2011

FDA approves Sutent for patients with progressive neuroendocrine cancerous tumors in pancreas

The U.S. Food and Drug Administration today approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic).

21 May 2011

EMA CHMP recommends conditional marketing authorization of FAMPYRA

The Committee for Medicinal Products for Human Use of the European Medicine Agency has recommended conditional marketing authorization of FAMPYRA (prolonged-release fampridine 10 mg tablets) for the improvement of walking in adult patients with multiple sclerosis with walking disability.

20 May 2011

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Amgen today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended a positive opinion for the marketing authorization of XGEVA (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.

20 May 2011

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Merck, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELIS (boceprevir) for the treatment of chronic hepatitis C virus genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

20 May 2011

Abbott appreciates FDA Advisory Committee recommendations to retain Trilipix indication for mixed dyslipidemia

The U.S. Food and Drug Administration today held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of the ACCORD Lipid study as they relate to the use of fenofibric acid (sold as Trilipix in the United States) in combination with a statin in patients with mixed dyslipidemia and at high risk of heart disease.

20 May 2011

Bayer, Onyx to present Nexavar-chemotherapy combination Phase 2b trial data in breast cancer at ASCO 2011

Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. today announced results from a Phase 2b trial evaluating Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic breast cancer previously treated with a bevacizumab-containing regimen, which showed that Nexavar was associated with statistically significant improvements in progression-free survival and time-to-progression.

20 May 2011

$Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma$

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

Onyx Pharmaceuticals, Inc. today announced updated results from the Phase 2b 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. Carfilzomib achieved a clinical benefit rate (CBR) (minimal response or greater) in the study population of 37 percent with a duration of response (DOR) of 8.3 months.

20 May 2011

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

ViroPharma Incorporated today announced initiation of a Phase 2 dose-ranging clinical study to evaluate the safety, tolerability, and efficacy of VP 20621 for prevention of recurrence of Clostridium difficile infection (CDI) in adults previously treated for CDI.

20 May 2011

AstraZeneca announces encouraging results from olaparib phase II study in serous ovarian cancer

AstraZeneca announced today encouraging results from a phase II study in patients with platinum-sensitive relapsed serous ovarian cancer (SOC) who had received maintenance treatment with the investigational drug olaparib, after the completion of chemotherapy.

19 May 2011

USPTO grants four key patents for Alvine's proteases to detect celiac disease

Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, today announced that the United States Patent and Trademark Office has issued four key patents: 7,943,312; 7,928,056; 7,923,532; and 7,910,541, protecting various aspects of Alvine's core technology.

19 May 2011

Allergy towards electricity after chemotherapy

Janice Tunnicliffe, 55 has become allergic to electromagnetic fields and electricity after a course of chemotherapy for bowel cancer. Fortunately, despite the size of the tumor, her cancer had not spread, but it was decided that she should have chemotherapy after the surgery as a precautionary measure.

19 May 2011

Pfizer's axitinib Phase 3 trial in advanced renal cell carcinoma meets primary endpoints

Pfizer Inc. today announced data from the pivotal Phase 3 AXIS 1032 trial, showing that in patients with previously treated advanced renal cell carcinoma, axitinib significantly extended progression-free survival at the 47th Annual American Society of Clinical Oncology meeting in Chicago from June 3-7, 2011.

19 May 2011

New data on personalized approaches for skin, ovarian and lung cancer to be presented at ASCO meeting

Genentech, a member of the Roche Group, today announced that data showing new personalized approaches for people with skin and lung cancer, plus new data with Avastin in ovarian cancer, will be presented at the 47th Annual Meeting of the American Society of Clinical Oncology.

18 May 2011

Amgen announces primary results from XGEVA Phase 3 trial in castrate-resistant prostate cancer

Amgen today announced primary results of a pivotal Phase 3 trial demonstrating that XGEVA significantly increased bone metastasis-free survival for more than four months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone.

18 May 2011

Eli Lilly responds to Amylin's exenatide lawsuit

Eli Lilly and Company has provided additional perspective in response to Amylin Pharmaceuticals, Inc.'s lawsuit filed in the United States District Court for the Southern District of California.

17 May 2011

FDA nod for hepatitis C drug

Merck & Co have finally won the Food and Drugs Administration – FDA’S approval on Friday to sell a new drug considered a major advance against the liver-destroying hepatitis C virus. The drug brand named, Victrelis is expected to help transform treatment of the potentially fatal disease with higher cure rates and shorter courses of therapy for some patients. Merck shares rose 0.6 percent in after-hours trading to $37.33, up from their $37.08 close on the New York Stock Exchange. Approval of Victrelis was widely expected after a FDA advisory panel recommended the drug in an 18-0 vote in April.

17 May 2011

Amylin files lawsuit against Eli Lilly for improper commercialization of exenatide

Amylin Pharmaceuticals, Inc. today announced that it has filed a lawsuit against Eli Lilly and Company in the United States District Court for the Southern District of California, alleging that Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements with Amylin to maximize commercialization of exenatide.

16 May 2011

Positive results from EXPAREL Phase 3 study to be presented at ASCRS Annual Scientific Meeting

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that positive results from its Phase 3 study evaluating EXPAREL in patients following hemorrhoidectomy will be presented at the 2011 American Society of Colon and Rectal Surgeons Annual Scientific Meeting in Vancouver, British Columbia.

16 May 2011

Nausea News and Research

Further Reading

FDA approves SUTENT for treatment of pancreatic NET

Phase 3 open-label study of RELISTOR presented at American Pain Society meeting

FDA approves Sutent for patients with progressive neuroendocrine cancerous tumors in pancreas

EMA CHMP recommends conditional marketing authorization of FAMPYRA

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Abbott appreciates FDA Advisory Committee recommendations to retain Trilipix indication for mixed dyslipidemia

Bayer, Onyx to present Nexavar-chemotherapy combination Phase 2b trial data in breast cancer at ASCO 2011

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

AstraZeneca announces encouraging results from olaparib phase II study in serous ovarian cancer

USPTO grants four key patents for Alvine's proteases to detect celiac disease

Allergy towards electricity after chemotherapy

Pfizer's axitinib Phase 3 trial in advanced renal cell carcinoma meets primary endpoints

New data on personalized approaches for skin, ovarian and lung cancer to be presented at ASCO meeting

Amgen announces primary results from XGEVA Phase 3 trial in castrate-resistant prostate cancer

Eli Lilly responds to Amylin's exenatide lawsuit

FDA nod for hepatitis C drug

Amylin files lawsuit against Eli Lilly for improper commercialization of exenatide

Positive results from EXPAREL Phase 3 study to be presented at ASCRS Annual Scientific Meeting

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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