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 Theravance's VIBATIV for treating complicated skin and skin structure infections

Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved VIBATIV™ (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.

14 Sep 2009

Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Genzyme Corporation reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab.

14 Sep 2009

AVONEX results in fewer injection site reactions, according to a clinical study

Data from an observational phase IV study of 499 patients entitled The Swiss MS Skin Project show that multiple sclerosis (MS) patients taking AVONEX (interferon beta-1a IM) reported significantly fewer injection site reactions (ISRs) compared to patients on Betaferon- (interferon beta-1b), Copaxone- (glatiramer Acetate) or Rebif - (interferon beta-1a).

13 Sep 2009

Cymbalta maintains reduction in pain for patients with chronic low back pain

New data show patients with chronic low back pain on Cymbalta(R) (duloxetine HCl) maintained reductions in pain for 41 weeks. In patients who initially responded to duloxetine, this maintenance of pain reduction was accompanied by further reduction in pain that was statistically significant as measured by the Brief Pain Inventory (BPI) average pain rating.

11 Sep 2009

Phase 3 trial results of LEVADEX orally inhaled migraine therapy to be presented

MAP Pharmaceuticals, Inc. announced today that it will present analysis of data from the efficacy portion of the first Phase 3 trial of its novel LEVADEX orally inhaled migraine therapy, currently in development, at the 14th Congress of the International Headache Society.

11 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Teva's COPAXONE holds promise for relapsing remitting multiple sclerosis

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today presented data that demonstrated patients treated for 10 and 15 years with COPAXONE® (glatiramer acetate injection) had significant reduction in disease severity. These data, generated from the longest continuous prospective study of any disease modifying therapy in relapsing remitting multiple sclerosis (RRMS), were presented today at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany.

10 Sep 2009

Phase III trial demonstrates rapid efficacy of Zelrix in treating acute migraine

NuPathe Inc., a specialty pharmaceutical company developing innovative products for the treatment of neurological and psychiatric diseases, today announced data from the pivotal Phase III trial of Zelrix™, a novel transdermal patch in clinical development for the treatment of acute migraine. Zelrix combines NuPathe’s proprietary SmartRelief™ iontophoretic transdermal technology with sumatriptan, the most prescribed treatment for acute migraine in the United States.

10 Sep 2009

METOZOLV drug approved for treating gastroesophageal reflux disease

Wilmington Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV ODT (metoclopramide HCl), an orally disintegrating formulation of metoclopramide for the treatment of gastroesophageal reflux disease (GERD) and diabetic gastroparesis.

10 Sep 2009

Merck's GARDASIL receives approval from FDA Advisory Committee

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

10 Sep 2009

Caldolor launched ahead of schedule in U.S. by Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it has successfully implemented the U.S. launch of Caldolor((R)), an intravenous formulation of ibuprofen, designed primarily for use in the hospital setting.

9 Sep 2009

FDA approves Salix' METOZOLV ODT for treating diabetic gastroparesis

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV™ ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. METOZOLV ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy1.

9 Sep 2009

Meda launches EDLUAR in the U.S.

Meda Pharmaceuticals Inc. (Meda) today announced the commercial availability of EDLUAR(TM) (zolpidem tartrate sublingual tablets) in the United States. EDLUAR is indicated for the short-term treatment of insomnia characterized by difficulties with falling asleep. EDLUAR is the first available under-the-tongue formulation of zolpidem tartrate, which is the most prescribed treatment for insomnia. Zolpidem tartrate is also the active ingredient in Ambien(R) oral tablets.

9 Sep 2009

Teva Pharmaceutical Industries to present MS treatment research data

Teva Pharmaceutical Industries Ltd. today announced that new research data furthering the clinical understanding of its diverse multiple sclerosis (MS) treatment franchise will be presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany, September 9-12, 2009.

9 Sep 2009

Study to test efficacy of lapatinib in advanced hepatocellular carcinoma

Use of the molecularly targeted agent lapatinib to delay tumor growth and improve the survival of patients with inoperable hepatocellular carcinoma, or liver cancer, only benefited certain subgroups of patients. While results of this study were largely negative, patients that exhibited toxicity from the drug in the form of a skin rash appeared to have a greater tumor response and longer survival.

9 Sep 2009

DOR's Phase 1/2 clinical trial for prevention of radiation enteritis receives NIH grant

DOR BioPharma, Inc. (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biotechnology company, announced today that the National Institutes of Health (NIH) has awarded DOR a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 1/2 clinical trial evaluating DOR201, a time-release formulation of oral beclomethasone dipropionate (oral BDP), for the prevention of acute radiation enteritis.

8 Sep 2009

Third human clinical trial of LigoCyte's norovirus vaccine started

LigoCyte Pharmaceuticals, Inc. announced today that it has initiated its third human clinical trial of its norovirus vaccine. The Phase I/II study will assess safety and immunogenicity associated with LigoCyte's investigational, nasally-delivered, dry powder vaccine in healthy adults. The study will also assess potential protection against clinical symptoms of norovirus infection by including a live virus challenge of subjects that have received either the vaccine or placebo.

8 Sep 2009

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl).

4 Sep 2009

Biogen Idec's MS franchise to present at the 25th Congress of ECTRIMS

Biogen Idec today announced more than 70 platform and poster presentations from the company’s multiple sclerosis (MS) franchise being presented during the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany.

3 Sep 2009