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Dyax to present data of KALBITOR inhibitor for Angioedema at ACAAI Meeting

Dyax Corp. today announced that an abstract featuring KALBITOR (ecallantide) data was accepted for oral presentation at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting held November 11-16, at the Phoenix Convention Center in Phoenix, AZ. Two additional abstracts were selected as poster sessions.

15 Nov 2010

Nplate reduces treatment failure and splenectomies in adults with chronic immune thrombocytopenia

Amgen Inc. today announced the publication of results from the first open-label study to compare Nplate® (romiplostim) treatment to standard of care therapies (SOC) in non-splenectomized adult patients with chronic immune thrombocytopenia (ITP). The study results, which were published today in the New England Journal of Medicine (NEJM), show that both the incidence of treatment failure and need for splenectomy were reduced among the Nplate-treated patients.

11 Nov 2010

Covidien analysis finds lower incidence of GI adverse events with topical NSAIDs versus oral

Covidien, a leading global provider of healthcare products, announced the results of an analysis that will be presented at the American College of Rheumatology's Annual Scientific Meeting. A pooled analysis of safety data suggests that patients with knee osteoarthritis (OA) receiving the topical PENNSAID® (diclofenac sodium topical solution) 1.5% w/w had significantly fewer gastrointestinal (GI)-related adverse events than those receiving an oral non-steroidal anti-inflammatory drug (NSAID).

10 Nov 2010

FDA grants Cadence marketing approval for OFIRMEV injection in management of pain and fever

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

3 Nov 2010

Salix to discuss XIFAXAN therapy for hepatic encephalopathy at AASLD 2010 Annual Meeting

Salix Pharmaceuticals, Inc. today announced that the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2010) will be an important venue for ongoing discussion of hepatic encephalopathy, or HE.

1 Nov 2010

Gilead to present data of two Phase III trials evaluating Viread efficacy for HBV infection at The Liver Meeting 2010

Gilead Sciences, Inc. today announced new data from the open-label phase of two pivotal Phase III clinical trials (Studies 102 and 103) evaluating the four-year efficacy of Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B virus (HBV) infection.

1 Nov 2010

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.

19 Oct 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010

Alkermes' VIVITROL medication for treatment of opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL(naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence, following opioid detoxification.

13 Oct 2010

ISTA Pharmaceuticals announces Phase 1/2 clinical study results of bepotastine besilate nasal spray

ISTA Pharmaceuticals, Inc., today announced positive preliminary results from a Phase 1/2 clinical study of bepotastine besilate nasal spray conducted in Canada for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies.

6 Oct 2010

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

6 Oct 2010

Merck to appeal against jury verdict in retrial of federal FOSAMAX case

Merck & Co., Inc. today said it will appeal a decision by the U.S. District Court for the Southern District of New York that reduced the jury verdict from $8 million to $1.5 million but denied Merck's request for judgment in its favor or a new trial in the case of Boles v. Merck, a retrial of a federal FOSAMAX case.

5 Oct 2010

Zyclara 3.75% more effective than cryotherapy alone in treatment of Actinic Keratoses: Study

Results from a randomized, double-blinded, placebo-controlled, multicentred study just published in the Journal of Drugs in Dermatology shows that treating Actinic Keratoses (AK) with imiquimod 3.75% (Zyclara®) following cryotherapy was more effective than cryotherapy alone in reducing total AK lesion count and achieving complete clearance of AK.

30 Sep 2010

PGIC analysis indicates tapentadol ER tablets provide significant improvement in pain intensity

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic low back pain have been published online by Expert Opinion on Pharmacotherapy. In addition, this study compared oxycodone controlled-release (CR) to placebo as an active control.

28 Sep 2010

Talecris Biotherapeutics announces 2010 eALTA award recipients

Talecris Biotherapeutics GmbH announced yesterday the recipients of the 2010 European alpha1-antitrypsin Laurell's Training Awards (eALTA). The annual awards, sponsored by Talecris, provide two fellowships of 50,000 euros to young investigators whose research aims to enhance the understanding and treatment of alpha1-antitrypsin deficiency (AAT deficiency).

21 Sep 2010

FDA Advisory Committee recommends approval of Alkermes' VIVITROL for opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.

17 Sep 2010

Incyte Corporation publishes clinical trial data of INCB18424 drug for myelofibrosis treatment

Incyte Corporation, Results from a Phase I/II study of Incyte's janus kinase (JAK) inhibitor with the investigational name INCB18424 (also known as INCB018424 and INC424) were published today in The New England Journal of Medicine, demonstrating marked and durable clinical benefits in patients with myelofibrosis.

16 Sep 2010

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

14 Sep 2010

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

Incyte Corporation announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its JAK1 and JAK2 inhibitor, INCB18424 in patients with polycythemia vera (PV), a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs).

13 Sep 2010

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Purdue Pharma L.P. will present data from the clinical program for Butrans™ (buprenorphine) Transdermal System CIII in a series of posters at PAINWeek®2010, September 8-10 in Las Vegas.

10 Sep 2010