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.

Kalbitor drug approved by FDA

The U.S. Food and Drug Administration approved Kalbitor (ecallantide) on Dec. 1 to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).

2 Dec 2009

Javelin Pharmaceuticals submits an NDA for Dyloject Injection

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, for the management of acute moderate-to-severe pain in adults.

2 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

Roche announces results of phase III taspoglutide study in diabetes patients

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed the results of the second and third of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s research and developed by Roche.

2 Dec 2009

J&JPRD submits an NDA for tapentadol ER tablets

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol extended release (ER) tablets, an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older.

2 Dec 2009

FDA grants approval for Dyax' KALBITOR for treating HAE patients

Dyax Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted approval for KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

2 Dec 2009

Amgen to present updated data on Nplate at the 2009 ASH meeting

Amgen Inc. today announced that it will present updated long-term safety and efficacy data for Nplate® (romiplostim) in adult chronic immune (idiopathic) thrombocytopenic purpura (ITP). Additionally, Amgen will present the first Nplate study in a pediatric setting as well as in patients with myelodysplastic syndromes (MDS) at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition (Dec. 5 - 8, 2009).

1 Dec 2009

QRxPharma commences Phase 3 pivotal trial of MoxDuo IR

QRxPharma Limited announced today, as part of its Phase 3 program, the initiation of a registration (also called pivotal) trial (Study 008) comparing efficacy and safety profiles of MoxDuo(TM)IR against component doses of morphine and oxycodone alone for the management of moderate to severe post-operative pain following bunionectomy surgery. The Company expects to complete dosing by close of Q2 2010.

30 Nov 2009

Allos Therapeutics granted U.S. patent for FOLOTYN

Allos Therapeutics, Inc. today announced that the United States Patent and Trademark Office has issued a patent for the use of FOLOTYN™ (pralatrexate injection) for the treatment of T-cell lymphoma. U.S. Patent No. 7,622,470 was issued to Memorial-Sloan Kettering Cancer Center, SRI International and Southern Research Institute, and expires on November 24, 2025.

30 Nov 2009

Eli Lilly's Cymbalta receives FDA approval

The U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults, announced Eli Lilly and Company (NYSE: LLY).

30 Nov 2009

Erbitux drug can reverse rare stomach disorder, report researchers

A drug used to treat colorectal cancer also can reverse a rare stomach disorder and should be considered first-line therapy for the disease, researchers at Vanderbilt University Medical Center report this week.

25 Nov 2009

Additional data on lubiprostone presented at the GASTRO 2009 UEGF/WCOG meeting

Sucampo Pharma Europe, Ltd., and Sucampo Pharma Americas, Inc., subsidiaries of Sucampo Pharmaceuticals, Inc., today presented additional clinical data for lubiprostone (Amitiza®) at GASTRO 2009 UEGF/WCOG, the joint meeting of the United European Gastroenterology Federation (UEGF), the World Gastroenterology Organisation (WGO), the World Organisation of Digestive Endoscopy (OMED) and the British Society of Gastroenterology (BSG), in London.

25 Nov 2009

Eisai's NDA for Aricept tablets for treatment of Alzheimer's disease accepted for review

Eisai Inc. and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's New Drug Application (NDA) for once daily 23 mg Aricept® (donepezil HCl extended release) tablets for the treatment of moderate to severe Alzheimer's disease (AD).

25 Nov 2009

U.S. Court rules in Merck's favor in Flemings case involving FOSAMAX

Merck said today that U.S. District Court Judge John F. Keenan granted summary judgment in Merck's favor in Flemings v. Merck. Flemings is the second of three cases involving FOSAMAX (alendronate sodium) designated by the federal MDL court as a bellwether trial case.

24 Nov 2009

A.P. Pharma regains compliance with shareholders’ equity requirement for continued listing on Nasdaq Capital Market

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that, on November 19, 2009, the Company received notice from the Nasdaq Listing Qualifications Panel that it has regained compliance with the shareholders’ equity requirement for continued listing on the Nasdaq Capital Market.

23 Nov 2009

FDA approves sNDA for pediatric autism drug ABILIFY

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

20 Nov 2009

Study reveals effectiveness of radiation therapy in achieving local control and palliation in patients with PNTs

Radiation therapy is effective in achieving local control and palliation in patients with pancreatic neuroendocrine tumors (PNTs), despite such tumors being commonly considered resistant to radiation therapy, according to a largest of its kind study in the November 15 issue of the International Journal of Radiation Oncology*Biology*Physics, the official journal of the American Society for Radiation Oncology (ASTRO).

20 Nov 2009

EMEA's CHMP recommends approval of Merck's ELONVA

Merck & Co., Inc. today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA® (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.

20 Nov 2009

Swissmedic grants marketing authorization for Amitiza

Sucampo Pharma Europe Ltd., a subsidiary of Sucampo Pharmaceuticals, Inc., today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted a marketing authorization for Amitiza® (lubiprostone) 24 microgram (mcg) gel capsules for the long-term treatment of patients with chronic idiopathic constipation (CIC).

20 Nov 2009

FDA issues complete response for Rituxan, a drug for treating chronic lymphocytic leukemia

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies’ applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL).

19 Nov 2009