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 Advisory Committee approves use of Selzentry tablets in combination with HIV therapy

Pfizer Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee voted (10 to 4) to recommend the approval of Selzentry (maraviroc) tablets for use in treatment-naïve adult patients with CCR5-tropic HIV-1 virus as part of combination therapy.

9 Oct 2009

FDA files complaint against Rel's Foods for selling adulterated food products

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop the company from manufacturing, producing, and selling adulterated food products.

9 Oct 2009

BioDelivery Sciences' partner Meda to launch ONSOLIS for managing breakthrough pain

BioDelivery Sciences International, Inc. announced that its commercial partner Meda will launch the FDA-approved ONSOLIS (fentanyl buccal soluble film) next week for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

8 Oct 2009

FDA approves Daiichi Sankyo's sNDA for Welchol

Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy.

7 Oct 2009

Shire publishes efficacy study results of FOSRENOL and Renagel

Shire plc, the global specialty biopharmaceutical company, today announces the publication in Clinical Nephrology of findings from a head-to-head clinical study comparing the efficacy of two non-calcium based phosphate binders, FOSRENOL(R) (lanthanum carbonate) and sevelamer hydrochloride (Genzyme's Renagel(R)) in chronic kidney disease (CKD) patients on haemodialysis.

7 Oct 2009

Opioid drugs may not be effective for osteoarthritis

Should you take opioid drugs for hip and knee pain caused by osteoarthritis? Probably not, suggests a new review of the best research on the subject.

7 Oct 2009

New fruit-flavored protein drinks for nutritionally challenged

The Isopure Company, LLC. announced today the U.S. launch of Isopure Plus - a new line of clear, fruit-flavored protein drinks offering seniors and people with nutritional challenges a great-tasting, easy-to-digest alternative to thick milkshake-like protein formulations.

6 Oct 2009

Schering-Plough receives FDA recommendation approval for PEGINTRON

Schering-Plough Corp. announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma.

6 Oct 2009

FOLOTYN available for commercial sale in the United States

Allos Therapeutics, Inc. today announced that FOLOTYN (pralatrexate injection) is now available for commercial sale in the United States. The U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) on September 24, 2009. This indication is based on overall response rate.

6 Oct 2009

Bristol-Myers Squibb to present new data on BARACLUDE and other compounds at the AASLD 2009

New data on four Bristol-Myers Squibb Company (NYSE:BMY) compounds will be presented at the 60th annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston from October 30 to November 3.

3 Oct 2009

Orexigen's Empatic Phase 2b results demonstrate weight loss

Orexigen Therapeutics, Inc. today announced that its 24-week, Phase 2b trial for Empatic(TM) (bupropion SR/zonisamide SR), the Company's second late stage investigational combination drug for the treatment of obesity, met its primary efficacy endpoint by demonstrating statistically significantly greater weight loss for both Empatic doses compared to monotherapies and placebo.

1 Oct 2009

Health Canada approves VIBATIV for treating complicated skin and skin structure infections

Astellas Pharma Canada, Inc. announced today that Health Canada has approved VIBATIV(TM) (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

1 Oct 2009

Januvia in combination with metformin or taken alone lowers blood sugar

A post-hoc analysis, presented at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD), of data pooled from studies of 104 weeks in duration showed ‘Januvia’ (sitagliptin), when taken alone or in combination with metformin, provided significant blood sugar lowering over two years.

29 Sep 2009

Safety profiles of JANUVIA and JANUMET drugs established through clinical development program

Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients.

28 Sep 2009

Phase 2 clinical trial results of IMO-2055 announced

Idera Pharmaceuticals, Inc., today announced the presentation of final data from a clinical trial evaluating IMO-2055, an agonist of Toll-like Receptor (TLR) 9, as monotherapy in patients with Renal Cell Carcinoma (RCC). The data are being presented during the Eighth International Kidney Cancer Symposium being held in Chicago, September 25-26, 2009.

28 Sep 2009

FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

28 Sep 2009

Pfizer to commence Phase 3 trial of oral c-Met and ALK inhibitor

Pfizer Oncology announced today that it will initiate a global, Phase 3 clinical trial of its investigational oral c-Met and ALK inhibitor, PF-02341066, versus standard of care chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) carrying the ALK (anaplastic lymphoma kinases) fusion gene, who have progressed on one prior treatment with a platinum-based chemotherapy.

26 Sep 2009

Morphotek announces preliminary data from Phase II trial of farletuzumab

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, today announced preliminary data from a Phase II trial evaluating the safety and efficacy of farletuzumab in platinum-sensitive epithelial ovarian cancer subjects experiencing their first relapse. Farletuzumab (MORAb-003) is a humanized monoclonal antibody that targets the Folate Receptor Alpha (FRA).

26 Sep 2009

European CHMP recommends Merck's JANUVIA and JANUMET as add-on to insulin

Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for JANUVIA® tablets and JANUMET® tablets recommending their use as add-on to insulin for the treatment of type 2 diabetes.

26 Sep 2009

European CHMP recommends marketing approval for Sanofi-aventis' Multaq

Sanofi-aventis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Multaq(R) (dronedarone - 400mg Tablets).

26 Sep 2009