Pruritus News and Research

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Studies show XIFAXAN 550 mg tablets demonstrate significant relief of global IBS symptoms

Salix Pharmaceuticals, Ltd. today announced the New England Journal of Medicine has published results from TARGET 1 and TARGET 2, the Company's two pivotal Phase 3 efficacy and safety studies of XIFAXAN (rifaximin) 550 mg tablets for the treatment of Irritable Bowel Syndrome without constipation, or Non-C IBS.

6 Jan 2011

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Celgene International Sàrl announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

5 Jan 2011

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.

23 Dec 2010

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Incyte Corporation announced today positive top-line results from COMFORT-I, the pivotal Phase III clinical trial of INCB18424 (also known as INC424) in patients with myelofibrosis (MF) being conducted under a Food and Drug Administration (FDA) Special Protocol Assessment (SPA) Agreement. COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) is a double-blind, placebo-controlled Phase III trial involving 309 patients.

21 Dec 2010

ISTA commences bepotastine besilate nasal spray Phase 2 study in seasonal allergic rhinitis

ISTA Pharmaceuticals, Inc., today announced it has initiated a Phase 2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group environmental study will evaluate the safety and efficacy of bepotastine besilate, dosed twice daily, in patients presenting with allergic rhinitis caused by one of the most potent seasonal allergy triggers, Mountain Cedar pollen.

14 Dec 2010

Talecris initiates clinical trial to evaluate 2 doses of PROLASTIN-C for emphysema due to AAT deficiency

Talecris Biotherapeutics, Inc. announced today the initiation of a clinical trial evaluating the safety and the pharmacokinetic profile of two doses of PROLASTIN®-C (Alpha(1)-Proteinase Inhibitor [Human]) (A1PI), a therapy indicated for chronic augmentation and maintenance in adults with emphysema due to alpha(1)-antitrypsin (AAT) deficiency. AAT deficiency is a rare, genetic disorder in which low levels of the alpha(1) protein circulating in the lungs can increase an individual's risk of developing emphysema.

10 Dec 2010

Data from comparative REVLIMID study in multiple myeloma presented at 52nd ASH

Celgene International Sàrl today announced that data from a randomised clinical study conducted by the Eastern Cooperative Oncology Group (ECOG) were presented at the 52nd Annual Meeting of the American Society of Hematology comparing REVLIMID® (lenalidomide) plus low-dose dexamethasone (Rd) to lenalidomide plus high-dose dexamethasone (RD) in both younger and older newly-diagnosed multiple myeloma patients (NDMM).

7 Dec 2010

Positive interim data from Phase I/II trial of CYT387 in myelofibrosis presented at ASH Annual Meeting

YM BioSciences Inc. today announced positive interim data from the first 60 patients enrolled in the Phase I/II trial for its JAK1/JAK2 inhibitor, CYT387, in myelofibrosis. The results were reported today in an oral presentation at the 52nd American Society of Hematology Annual Meeting being held in Orlando, Florida.

7 Dec 2010

Amgen announces final study results of Nplate in adults with chronic ITP

Amgen Inc. today announced the final results from a 5-year open-label extension study investigating the long-term efficacy and safety of Nplate (romiplostim) in adult chronic immune (idiopathic) thrombocytopenic purpura. Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events.

6 Dec 2010

Study: REVLIMID and dexamethasone for high-risk smoldering multiple myeloma reduce risk of disease progression

Celgene International Sàrl (NASDAQ: CELG) announced that data evaluating combination therapy REVLIMID® (lenalidomide) and dexamethasone in patients with high-risk asymptomatic smoldering multiple myeloma were presented during the American Society of Hematology's annual meeting. The study reported REVLIMID and dexamethasone prolonged time to progression.

6 Dec 2010

Investigational study data of REVLIMID with rituximab or rituximab-containing regimen in CLL patients presented at ASH

Celgene International Sàrl announced that clinical data from two investigational studies evaluating the use of REVLIMID (lenalidomide) either with rituximab or following a rituximab-containing regimen in patients with chronic lymphocytic leukaemia were presented at the 52nd American Society of Hematology annual meeting.

6 Dec 2010

Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Amgen today announced that it will present data from several key Nplate (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla.

2 Dec 2010

Elorac's naloxone lotion receives FDA Orphan Drug Designation for pruritus associated with mycosis fungoides

Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders announced that it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for its naloxone lotion for the topical treatment of pruritus accompanying cutaneous t-cell lymphoma (CTCL, also known as mycosis fungoides).

1 Dec 2010

Arthritis Foundation, Covidien join forces to help Americans suffering from osteoarthritis

The Arthritis Foundation and Covidien have joined forces to help advance awareness and support for millions of people suffering from osteoarthritis in the United States.

23 Nov 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Celldex presents ACT III Phase 2 clinical trial data for glioblastoma multiforme at SNO Meeting

Celldex Therapeutics, Inc., today announced the presentation of complete data for the primary endpoint of ACT III, a multi-center, single arm, Phase 2 clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed glioblastoma multiforme (GBM).

21 Nov 2010

Merck wins third FOSAMAX bellwether trial

Merck & Co., Inc. today said a federal court jury in New York found in its favor in the Graves v. Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems on her FOSAMAX use. With today's verdict, Merck has won three of the first four bellwether cases in the FOSAMAX litigation.

20 Nov 2010

CMS grants Qutenza J-code to NeurogesX

NeurogesX, Inc. a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced that the Centers for Medicare and Medicaid Services (CMS) has granted a unique, Level II Health Care Common Procedural Coding System (Level II HCPCS), commonly referred to as a J-code, for Qutenza (capsaicin) 8% patch.

19 Nov 2010

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.

18 Nov 2010

Talecris announces publication of A1PI studies for AAT deficiency in Respiratory Research journal

Talecris Biotherapeutics announced today the publication of combined data from two studies demonstrating that augmentation therapy with Alpha(1)-Proteinase Inhibitor (Human) (A1PI) significantly reduces lung tissue loss in patients with emphysema related to Alpha(1)-antitrypsin (AAT) deficiency.

15 Nov 2010

Pruritus News and Research

Studies show XIFAXAN 550 mg tablets demonstrate significant relief of global IBS symptoms

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

ISTA commences bepotastine besilate nasal spray Phase 2 study in seasonal allergic rhinitis

Talecris initiates clinical trial to evaluate 2 doses of PROLASTIN-C for emphysema due to AAT deficiency

Data from comparative REVLIMID study in multiple myeloma presented at 52nd ASH

Positive interim data from Phase I/II trial of CYT387 in myelofibrosis presented at ASH Annual Meeting

Amgen announces final study results of Nplate in adults with chronic ITP

Study: REVLIMID and dexamethasone for high-risk smoldering multiple myeloma reduce risk of disease progression

Investigational study data of REVLIMID with rituximab or rituximab-containing regimen in CLL patients presented at ASH

Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Elorac's naloxone lotion receives FDA Orphan Drug Designation for pruritus associated with mycosis fungoides

Arthritis Foundation, Covidien join forces to help Americans suffering from osteoarthritis

VYTORIN reduces major vascular events in patients with chronic kidney disease

Celldex presents ACT III Phase 2 clinical trial data for glioblastoma multiforme at SNO Meeting

Merck wins third FOSAMAX bellwether trial

CMS grants Qutenza J-code to NeurogesX

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Talecris announces publication of A1PI studies for AAT deficiency in Respiratory Research journal

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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