Pruritus News and Research

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FDA approves Iroko Pharmaceuticals’ ZORVOLEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved ZORVOLEX™ (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults. ZORVOLEX was approved at dosage strengths that are 20 percent lower than currently available diclofenac products.

19 Oct 2013

FDA approves Cimzia for treatment of adults with active ankylosing spondylitis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis.

18 Oct 2013

FDA approves Cimzia (certolizumab pegol) for active psoriatic arthritis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis.

30 Sep 2013

Lumena Pharmaceuticals initiates LUM001 clinical program in children with ALGS

Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced the initiation of a global clinical program to evaluate its drug candidate LUM001 in children with Alagille syndrome. The first patient has been dosed in the IMAGO Phase II study being conducted in the U.K., and enrollment of pediatric patients is expected to begin later this year in the ITCH Phase II study in the U.S.

26 Sep 2013

Creabilis treats first atopic dermatitis patients in CT327 Phase 2b study

Creabilis, a late clinical stage European dermatology company with a focus on pruritus (itch), today announces it has treated the first patients in its Phase 2b study of its lead product, CT327, in patients with atopic dermatitis.

18 Sep 2013

Nuvo: FDA accepts to review New Drug Application for PENNSAID 2%

Nuvo Research Inc., a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10 today announced that its U.S. licensee for PENNSAID (diclofenac sodium topical solution) 1.5% w/w and PENNSAID 2% (diclofenac sodium topical solution) 2% w/w, Mallinckrodt has advised that the U.S. Food and Drug Administration has accepted for filing and review the New Drug Application for PENNSAID 2% submitted by Mallinckrodt on August 7, 2013.

22 Aug 2013

Tigercat and Velocity Pharmaceutical announce submission of IND application to FDA for VPD-737

Velocity Pharmaceutical Development, LLC ("VPD") and Tigercat Pharma, Inc., ("Tigercat") announced today the submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for VPD-737 for the treatment of chronic pruritus.

19 Aug 2013

GlaxoSmithKline receives CHMP positive opinion for REVOLADE

Ligand Pharmaceuticals Incorporated partner GlaxoSmithKline announced that today, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorization for GSK's REVOLADE (eltrombopag) as a treatment for low platelet counts (thrombocytopenia) in adult patients with chronic hepatitis C infection, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy

26 Jul 2013

First lots of 2013-2014 seasonal influenza vaccine released for U.S. distribution

Sanofi Pasteur, the vaccines division of Sanofi, announced today that the first lots of Fluzone (Influenza Virus Vaccine) for the 2013-2014 season have been released by the U.S. Food and Drug Administration for U.S. distribution and were shipped July 24.

25 Jul 2013

Celgene to discontinue treatment with REVLIMID in phase III ORIGIN trial

Celgene Corporation today announced that after consultation with the U.S. Food and Drug Administration Celgene will discontinue treatment with REVLIMID (lenalidomide) in the open-label, phase III ORIGIN trial, which enrolled 450 patients in over 100 sites in 26 countries.

18 Jul 2013

FDA approves Gilotrif for patients with late stage non-small cell lung cancer

Companion test also approved to identify appropriate patients The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Lung cancer is the leading cause of cancer-related death among men and women.

16 Jul 2013

Phase III study: REVLIMID meets primary endpoint in patients newly diagnosed with multiple myeloma

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival.

11 Jul 2013

Data shows individualized regimens can help optimize prophylaxis treatment in hemophilia patients

Baxter International Inc. today announced data featuring ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], a leading recombinant treatment available worldwide, during the 24th Annual Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Amsterdam, The Netherlands.

From Baxter International Inc. 5 Jul 2013

European Commission amends marketing authorisation for Celgene's REVLIMID

Celgene International Sàrl was today notified that the European Commission has amended the marketing authorisation for REVLIMID. This decision means that REVLIMID is now approved to treat patients with transfusion-dependent anaemia due to low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

17 Jun 2013

Headline results of Creabilis' CT327 Phase 2b trial in psoriasis patients announced

Creabilis, a late stage European dermatology company with a focus on chronic pruritus (itch), today announces headline results of its Phase 2b trial with its lead product, CT327, in psoriasis patients.

10 May 2013

Maruishi gains exclusive rights to develop, commercialize Cara Therapeutics' CR845 in Japan

Cara Therapeutics, Inc. and Maruishi Pharmaceutical Company, Ltd. today announced that they have entered into a License Agreement providing Maruishi with exclusive rights to develop, manufacture and commercialize Cara's lead analgesic drug candidate, CR845, for acute pain and uremic pruritus in Japan.

29 Apr 2013

FDA grants Fast Track designation to Elorac's naloxone topical lotion

Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders, announced that the U.S. Food and Drug Administration has granted Fast Track designation to the Company's naloxone topical lotion for the relief of pruritus in patients with cutaneous T-cell lymphoma.

15 Apr 2013

Halometasone and fusidic acid optimal for infected eczema

Results from a randomized, open-label phase III trial suggest that a combination cream of halometasone and fusidic acid reduces symptoms of eczema to a similar degree to a betamethasone and neomycin sulphate cream, but is more effective at treating infected lesions.

8 Mar 2013

Laboratorios Grifols, Cadence announce new supply agreement for OFIRMEV

Cadence Pharmaceuticals, Inc., a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today announced a new supply agreement with Laboratorios Grifols, S.A. for the development, manufacture and supply of commercial quantities of OFIRMEV (acetaminophen) injection in flexible plastic bags.

6 Mar 2013

Regeneron, Sanofi announce pooled data from Phase 1b trials with dupilumab for atopic dermatitis

Sanofi and Regeneron Pharmaceuticals, Inc. announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami.

4 Mar 2013