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Interim data from Schering-Plough's narlaprevir Phase IIa study

Schering-Plough Corporation reported that interim results from an ongoing Phase IIa study of narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1.

3 Nov 2009

Positive results from Phase II clinical trial of INT-747 announced

Intercept Pharmaceuticals, Inc., today announced positive results from a 165 patient, placebo controlled, double-blind Phase II clinical trial of INT-747 in patients with primary biliary cirrhosis (PBC).

27 Oct 2009

CORD I phase III clinical trial results of XIAFLEX published

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that The New England Journal of Medicine (NEJM) has published in its September 3rd edition, the Company's pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum) a novel, first-in-class, biologic for the nonsurgical treatment of Dupuytren's contracture.

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

Genentech and Biogen Idec submit applications to FDA for Rituxan in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).

20 May 2009

Serentis begins trial with first-in-class SRD441 for eczema

Serentis, a privately owned biopharmaceutical company, announced that it has commenced patient recruitment in a Phase II clinical trial for atopic dermatitis (AD), a type of eczema.

9 Apr 2009

Homeopathy in dogs pilot indicates need for larger clinical trial

Results from a small, rigorously designed, research study at the University of Bristol's Department of Clinical Veterinary Science have pointed the way towards a larger clinical trial of homeopathy for the treatment of atopic dermatitis in dogs.

7 Apr 2009

European Commission and US FDA approve intravenous formulation of temozolomide

Schering-Plough Corporation (NYSE:SGP) today announced that the European Commission and the US FDA both approved the intravenous (IV) formulation of temozolomide as an alternative to the already approved oral form of the drug.

5 Mar 2009

Itching after burns - study offers best options

Jim Mashburn felt his legs cook. Mr. Mashburn, a worker at a paper-recycling plant, fell through a loose grate and into a sump pit in September 2008 as he was preparing to inspect a steam valve. Super hot condensate, at a temperature of at least 140 degrees Fahrenheit, enveloped his legs instantly, searing skin up to his thighs.

26 Feb 2009

Pre-emptive treatment helped curtail skin toxicity with Panitumumab

With a pre-emptive, prophylactic skin regimen, patients who receive panitumumab for treatment of metastatic colorectal cancer may be able to avoid some of the skin-associated toxicities, according to data presented at the 2009 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco.

19 Jan 2009

Rituxan in combination with chemo improves survival in chronic lymphocytic leukemia

Genentech, Inc. and Biogen Idec have announced that two global Phase III studies in chronic lymphocytic leukemia (CLL), CLL8 and REACH, showed Rituxan (rituximab) plus chemotherapy significantly increased the time patients lived without their disease advancing, as defined by the primary endpoint of progression-free survival (PFS), when compared to chemotherapy alone.

8 Dec 2008

Nplate receives positive opinion for marketing authorisation in Europe

Amgen has announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nplate (romiplostim) in the European Union (EU).

21 Nov 2008

Gleevec receives FDA priority review for gastrointestinal stromal tumors after surgery

Novartis has announced that Gleevec (imatinib mesylate) tablets, (known as Glivec (imatinib) outside the US, Canada and Israel), has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST).

27 Aug 2008

ISTA Pharmaceuticals announces new clinical findings to support Bepreve NDA

ISTA Pharmaceuticals, Inc. has announced positive results from the preliminary analysis of its second and final Bepreve (bepotastine ophthalmic solution) Phase III clinical study.

30 Apr 2008

Revlimid receives approval in Switzerland for treatment of multiple myeloma

Celgene International Sarl has announced that it's oral cancer drug, Revlimid (lenalidomide) has been granted approval by the Swiss Agency for Therapeutic Products (Swissmedic) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.

5 Sep 2007

FDA approval of cream to treat bacterial vaginosis

KV Pharmaceutical Company has announced that it has received approval from the United States Food and Drug Administration (FDA) to market Clindesse (clindamycin phosphate) Vaginal Cream, 2%, a single-dose prescription cream therapy indicated to treat bacterial vaginosis ("BV").

3 Dec 2004

FDA approves Remodulin for the treatment of pulmonary arterial hypertension

United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has issued an approval letter for the intravenous use of Remodulin based on data establishing its bioequivalence with the previously approved subcutaneous administration of Remodulin.

24 Nov 2004

Results from study of Rituxan in rheumatoid arthritis show promise

Genentech, Inc., Biogen Idec and Roche have announced that the New England Journal of Medicine published the results of a Phase IIa study showing that two doses of Rituxan® (Rituximab), administered two weeks apart, improved symptoms in patients with moderate-to-severe rheumatoid arthritis (RA) for up to 48 weeks when combined with methotrexate (MTX), compared to MTX alone.

16 Jun 2004