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Medivir announces phase III ATTAIN study of simeprevir inhibitor in treatment of adult patients with HCV

Medivir AB today announced that new phase III data for the once-daily protease inhibitor simeprevir have been presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL) in Brisbane, Australia.

19 Mar 2014

Bayer and Onyx announce Phase 3 trial evaluating use of NEXAVAR for patients with HCC after local ablation

Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that a Phase 3 trial evaluating the investigational use of NEXAVAR® (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC), or liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival.

11 Mar 2014

Incyte Corporation publishes results of Phase III trial of ruxolitinib in patients with polycythemia vera

Incyte Corporation (Nasdaq: INCY) today announced that a pivotal Phase III trial of ruxolitinib compared to best available therapy in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea has met its primary endpoint of achieving phlebotomy independence and reducing spleen size by 35 percent or more.

7 Mar 2014

Merck reports results from Phase 2b study of investigational house dust mite sublingual immunotherapy tablet

Merck, known as MSD outside the United States and Canada, today announced results from a Phase 2b study evaluating two doses of its investigational house dust mite sublingual immunotherapy tablet (MK-8237). The data were presented for the first time during a late-breaking oral session at the 2014 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego.

5 Mar 2014

AbbVie's PEARL-III study meets primary, secondary endpoints in patients with chronic GT1b HCV infection

The first detailed results from AbbVie's pivotal phase III study, PEARL-III, were presented today as part of the 21st Conference on Retroviruses and Opportunistic Infections (CROI) press conference and will also be presented as a late-breaker at the conference on March 4.

4 Mar 2014

FDA approves Iroko Pharmaceuticals’ TIVORBEX 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 TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults.

25 Feb 2014

Zoetis reports revenue of $1.25 billion for Q4 2013

Zoetis Inc. today reported its financial results for the fourth quarter and full year 2013. The company reported revenue of $1.25 billion for the fourth quarter of 2013, an increase of 7% from the fourth quarter of 2012. Revenue reflected an operational increase of 9%, with foreign currency having a negative impact of 2 percentage points.

11 Feb 2014

Mallinckrodt's subsidiary to acquire all outstanding shares of Cadence Pharmaceuticals

Mallinckrodt plc, a leading global specialty pharmaceuticals company, and Cadence Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which a subsidiary of Mallinckrodt plc will commence a tender offer to acquire all outstanding shares of Cadence Pharmaceuticals, Inc. for $14.00 per share in cash or approximately $1.3 billion on a fully diluted basis, which represents a 32% premium to the trailing 30-trading-day volume weighted average price (VWAP) of $10.62 per share for Cadence Pharmaceuticals, Inc.

11 Feb 2014

Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt today announced the commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the treatment of the pain of osteoarthritis of the knees.

10 Feb 2014

FDA approves New Drug Application for PENNSA 2%

Mallinckrodt today announced that the U.S. Food and Drug Administration has approved the New Drug Application for PENNSAID (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug approved for use in the treatment of the pain of osteoarthritis of the knee(s).

17 Jan 2014

FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the U.S. Food and Drug Administration has accepted for review the Supplemental New Drug Application for ZORVOLEX (diclofenac), a lower dose nonsteroidal anti-inflammatory drug, for the proposed indication of treatment of osteoarthritis pain in adults. ZORVOLEX was approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults.

15 Jan 2014

Health Canada approves Genzyme's Lemtrada for adults with relapsing remitting multiple sclerosis

Genzyme, a Sanofi company, announced today that Health Canada has approved Lemtrada (alemtuzumab) for the management of adult patients with relapsing remitting multiple sclerosis, with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.

13 Dec 2013

Crealta to acquire all assets of Savient Pharmaceuticals

Savient Pharmaceuticals, Inc. ("Savient") announced that it has reached agreement on the terms of an acquisition agreement with Crealta Pharmaceuticals LLC ("Crealta") through which Crealta would acquire substantially all of the assets of Savient, including all KRYSTEXXA® assets, for gross proceeds of approximately $120.4 million.

11 Dec 2013

Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that results from two studies of REVLIMID (lenalidomide) combinations in patients with diffuse large B-cell lymphoma (DLBCL) were presented at the American Society of Hematology annual meeting in New Orleans, La.

11 Dec 2013

Janssen reports positive pivotal Phase 2 study data of siltuximab for Multicentric Castleman's Disease

Janssen Research & Development, LLC today announced positive results from a pivotal Phase 2 global registration study (MCD2001) suggesting siltuximab, an investigational compound, along with best supportive care, exhibited statistically significant efficacy and a tolerable safety profile compared with placebo and BSC in treating patients with the rare disorder Multicentric Castleman's Disease who are HIV-negative and human herpes virus 8-negative.

8 Dec 2013

Takeda and Teva announce agreement related to commercialization of glatiramer acetate in Japan

Teva Pharmaceutical Industries Ltd. and Takeda Pharmaceutical Company Limited (Takeda) today announced the signing earlier this year of an agreement in which Teva licensed to Takeda the right to commercialize Teva's innovative glatiramer acetate ( active ingredient) formulation for the treatment of multiple sclerosis, in Japan.

4 Dec 2013

Novartis to present updates on broad cancer portfolio at ASH and SABCS symposiums

Novartis will present updates on its broad cancer portfolio with more than 240 abstracts at the upcoming American Society of Hematology (ASH) annual meeting and CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).

4 Dec 2013

NEXAVAR tablets receive FDA approval for treatment of patients with thyroid cancer

Bayer HealthCare and Onyx Pharmaceuticals, Inc., an Amgen subsidiary, today announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for the oral multi-kinase inhibitor NEXAVAR (sorafenib) tablets for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

23 Nov 2013

New hope for patients whose melanoma has metastasised to the brain

New data show that in patients whose melanoma (BRAF V600 mutation-positive) has spread (metastasised) to the brain, Zelboraf (vemurafenib) extends life expectancy by over six months compared to chemotherapy.1 These results are welcome news for patients suffering from metastatic melanoma, as up to half of these patients are diagnosed with brain metastases with many given less than six months to live.1

18 Nov 2013

Interim data from Phase 1B trial of an investigational anti-PD-1 immunotherapy in patients with previously-treated NSCLC announced by Merck

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced the presentation of interim data from a Phase 1B trial (PN001) evaluating MK-3475, an investigational anti-PD-1 immunotherapy, in patients with previously-treated non-small cell lung cancer (NSCLC). The data were presented today by Dr. Edward Garon, Director of Thoracic Oncology, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, at the 15th World Conference on Lung Cancer in Sydney, Australia (Abstract #2416).

31 Oct 2013