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.

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

Clinical trial results of sumatriptan published in a journal

NovaDel Pharma Inc. announced that an article titled “Rapid Oral Transmucosal Absorption of Sumatriptan, and Pharmacodynamics in Acute Migraine” was published online on June 22, 2009 in the peer-reviewed journal Headache: The Journal of Head and Face Pain.

3 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

CIF launches campaign by distributing a "Ten Tips "card to help parents easily identify potential life threatening injuries

As high school student-athletes begin the academic year and participate in double-day sports practices statewide, the California Interscholastic Federation is drawing attention to the health risks associated with concussions, heat stroke and dehydration.

3 Sep 2009

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009

Members of Independence Blue Cross will receive coverage for the administration costs of the H1N1 vaccine

In an effort to help keep members healthy and flu-free this year, Independence Blue Cross (IBC) will offer coverage for the administration costs of the H1N1 (swine flu) vaccine when it becomes available. In addition IBC will continue to cover seasonal flu vaccine.

2 Sep 2009

FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Valcyte(R) (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk of developing CMV disease.

31 Aug 2009

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring, Maryland. The panel is expected to consider the clinical trial results Genzyme submitted to support the approval and labeling of Clolar to treat older adult patients with acute myeloid leukemia (AML), the most common type of acute leukemia in adults.

29 Aug 2009

Forest Laboratories announces phase 3 trial results for roflumilast

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer and Nycomed, a privately owned pharmaceutical company, today announced that results of four phase III trials have been published in the prestigious peer-reviewed medical journal The Lancet showing that roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, improved lung function and reduced exacerbations in patients with moderate to severe COPD.

28 Aug 2009

Cumberland Pharmaceuticals posts $9.8 million revenues for the three months ended June 30, 2009

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announced second quarter 2009 financial results.

27 Aug 2009

Clinical data added to ORENCIA labeling help treat patients with rheumatoid arthritis

Bristol-Myers Squibb Company announced today that clinical data added to the labeling for ORENCIA (abatacept) support use of ORENCIA for patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration.

27 Aug 2009

European Medicines Agency validates Schering-Plough's MAA for nomegestrol acetate/17 beta-estradiol

Schering-Plough Corporation, (NYSE: SGP), today announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years of age and older.

27 Aug 2009

Nausea News and Research

Further Reading

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

FDA approves Salix' METOZOLV ODT for treating diabetic gastroparesis

Meda launches EDLUAR in the U.S.

Teva Pharmaceutical Industries to present MS treatment research data

Study to test efficacy of lapatinib in advanced hepatocellular carcinoma

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

Third human clinical trial of LigoCyte's norovirus vaccine started

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

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

Clinical trial results of sumatriptan published in a journal

Millennium's sNDA to be reviewed by the FDA

CIF launches campaign by distributing a "Ten Tips "card to help parents easily identify potential life threatening injuries

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Members of Independence Blue Cross will receive coverage for the administration costs of the H1N1 vaccine

FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Forest Laboratories announces phase 3 trial results for roflumilast

Cumberland Pharmaceuticals posts $9.8 million revenues for the three months ended June 30, 2009

Clinical data added to ORENCIA labeling help treat patients with rheumatoid arthritis

European Medicines Agency validates Schering-Plough's MAA for nomegestrol acetate/17 beta-estradiol

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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