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Vimpat provides long-term additional partial-onset seizure control when added to broad range of AEDs

New long term data showed that Vimpat- (lacosamide) C-V provided sustained reduction in seizure frequency for up to five years when used as an add-on treatment for uncontrolled partial onset seizures in adults with epilepsy. In addition post-hoc exploratory analyses showed that adjunctive lacosamide treatment reduced partial-onset seizure frequency and improved responder rates when added to a broad range of antiepileptic drugs (AEDs) including both traditional sodium channel-blocking agents and those that act on non-sodium channel-targets.

30 Jun 2010

AMAG, Takeda provide regulatory and clinical update for Feraheme Injection

AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today provided a regulatory and clinical update for Feraheme® (ferumoxytol) Injection for intravenous (IV) use.

29 Jun 2010

Study demonstrates effectiveness of pre-emptive pain management protocol using pregabalin in urologic surgery

Reporting in the journal Urology, researchers at Thomas Jefferson University have found that a pre-emptive multimodal pain regimen that included pregabalin (Lyrica) decreased the use of opioid analgesics in patients undergoing robotic-assisted laparoscopic radical prostatectomy.

28 Jun 2010

Merck challenges New York jury decision in federal FOSAMAX retrial

Merck & Co., Inc. today said it is challenging the decision returned by a New York jury in the retrial of a federal FOSAMAX case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010.

28 Jun 2010

Japan's MHLW grants full marketing authorization to REVLIMID

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy. This marketing authorization represents the first regulatory approval of REVLIMID in Japan.

25 Jun 2010

FDA approves new indication for Tasigna in treatment of rare blood cancer

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

18 Jun 2010

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence.

18 Jun 2010

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Celgene International Sàrl announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomized, double-blind study of continuous REVLIMID (lenalidomide) for the treatment of elderly patients with newly diagnosed multiple myeloma show improvement in progression-free survival, the primary endpoint of the study.

14 Jun 2010

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Celgene International Sàrl announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either lenalidomide (REVLIMID), melphalan and prednisone or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of lenalidomide plus low-dose dexamethasone (Rd) were presented at the American Society of Clinical Oncology annual meeting.

11 Jun 2010

Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

Salix Pharmaceuticals, Ltd. today announced that the Company has submitted an efficacy supplement to NDA 21-361 for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

8 Jun 2010

Researchers present data from Phase II study of lenalidomide in patients with untreated CLL at ASCO

Celgene International Sàrl today announced that researchers presented data from an investigator-initiated Phase II study of lenalidomide (REVLIMID) in untreated patients with chronic lymphocytic leukemia at the annual meeting of the American Society of Clinical Oncology.

8 Jun 2010

Promising clinical data on CDX-011 in metastatic melanoma presented at ASCO Annual Meeting

Celldex Therapeutics, Inc. today announced the presentation of promising clinical data on CDX-011 in metastatic melanoma at the 46th Annual Meeting of the American Society of Clinical Oncology in Chicago, Illinois. The Phase 2 study has met its primary endpoint and the results support additional studies in this indication.

7 Jun 2010

Data comparing NUCYNTA to oxycodone IR for osteoarthritis pain presented at 29th APS

A post-hoc analysis of a Phase 3 safety study demonstrated that NUCYNTA® (tapentadol) tablets were associated with a lower incidence of nausea, vomiting and constipation when compared to oxycodone immediate release (IR) tablets in elderly patients with moderate to severe low-back or osteoarthritis pain.

7 May 2010

Mayo Clinic Health Letter: UV light slows skin cell overgrowth, alters immune system

Ultraviolet light -- a culprit behind sunburns, wrinkles and skin cancer -- offers benefits for some skin conditions, according to the April issue of Mayo Clinic Health Letter.

9 Apr 2010

Phase III study results of Merck's allergy immunotherapy tablet

In new data from a Phase III study in 345 children and adolescents (ages 5-17 years), patients with grass pollen allergic rhinoconjunctivitis treated with Merck's investigational sublingual grass (Phleum Pratense) allergy immunotherapy tablet (AIT) showed a 26 percent greater improvement in the total combined score (daily symptom score and daily medication score), compared to patients receiving placebo

3 Mar 2010

Health Canada approves Talecris Biotherapeutics' PROLASTIN-C for AAT deficiency

Talecris Biotherapeutics announced today that it has received approval from Health Canada for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more purified and concentrated version of PROLASTIN® produced using advances in manufacturing technology. A similar approval for PROLASTIN-C was granted by the U.S. Food and Drug Administration on October 17, 2009.

17 Feb 2010

Health Canada approves Zyclara Cream for multiple actinic keratoses

Health Canada has approved Zyclara™ (imiquimod) Cream 3.75%, a topical prescription treatment for multiple actinic keratoses (AK) located on the face or balding scalp in adults. Actinic Keratosis is a common skin condition that can lead to squamous cell carcinoma, a form of non-melanoma skin cancer, if left untreated.

6 Jan 2010

Incyte's INCB18424 provides previously unachievable clinical benefits in myelofibrosis patients

Incyte Corporation announced this morning that INCB18424 (also referred to as INCB018424), its selective, orally available janus kinase (JAK) inhibitor, will be the subject of three oral presentations at the 51st American Society of Hematology (ASH) Annual Meeting in New Orleans.

7 Dec 2009

Positive data from Gloucester Pharmaceuticals' ISTODAX study presented at the ASH meeting

Gloucester Pharmaceuticals announced today the presentation of positive data from an analysis of ISTODAX® (romidepsin) in a subset of patients from Gloucester’s registration study in cutaneous T-cell lymphoma (CTCL) at the 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, LA.