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Obeticholic acid meets primary composite endpoint in Phase III study

Results from an international Phase III study presented today at the International Liver CongressTM 2014 have shown obeticholic acid (OCA) given to patients suffering from Primary Biliary Cirrhosis (PBC) who previously had an inadequate response to, or have been unable to tolerate ursodeoxycholic acid (UDCA), produced meaningful biochemical and clinical improvements. UDCA is the only therapy currently approved to treat PBC. [More]
OncoSec Medical to re-launch Phase II cutaneous T-cell lymphoma trial under protocol amendment

OncoSec Medical to re-launch Phase II cutaneous T-cell lymphoma trial under protocol amendment

OncoSec Medical Inc., a company developing its ImmunoPulse DNA-based immunotherapy to treat solid tumors, will re-launch its Phase II cutaneous T-cell lymphoma (CTCL) trial under a protocol amendment. [More]
FDA approves ORALAIR sublingual allergy immunotherapy tablet

FDA approves ORALAIR sublingual allergy immunotherapy tablet

GREER Laboratories, Inc., a leading developer and provider of allergy immunotherapy products and services, today announced that the U.S. Food and Drug Administration has approved ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) sublingual allergy immunotherapy tablet. [More]
SIFI, NovaMedica agree to market eight products for treatment of ophthalmic pathologies in Russia

SIFI, NovaMedica agree to market eight products for treatment of ophthalmic pathologies in Russia

Leading Italian developer of innovative eye care solutions S.I.F.I. S.p.A. and Russian pharmaceutical company NovaMedica have entered into an exclusive commercial agreement for NovaMedica to market eight products developed and licensed by SIFI for the treatment of a wide range of ophthalmic pathologies in Russia and the CIS. [More]

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

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. [More]
Incyte Corporation publishes results of Phase III trial of ruxolitinib in patients with polycythemia vera

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. [More]

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

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. [More]
FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

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. [More]
Zoetis reports revenue of $1.25 billion for Q4 2013

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. [More]

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. [More]
Mallinckrodt announces commercial launch of PENNSAID

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. [More]

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). [More]

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. [More]
Health Canada approves Genzyme's Lemtrada for adults with relapsing remitting multiple sclerosis

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. [More]
Crealta to acquire all assets of Savient Pharmaceuticals

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. [More]
Celgene subsidiary presents REVLIMID study results on lymphoma at ASH annual meeting

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

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. [More]
Takeda and Teva announce agreement related to commercialization of glatiramer acetate in Japan

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. [More]