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Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib.

1 Jun 2015

Amgen and Merck expand collaboration for Talimogene laherparepvec-KEYTRUDA combination study

Amgen and Merck, known as MSD outside the U.S. and Canada, today announced an expanded collaboration to evaluate the efficacy and safety of talimogene laherparepvec, Amgen's investigational oncolytic immunotherapy, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in a Phase 1, open-label trial of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

1 Jun 2015

Pembrolizumab (Keytruda) effective in patients with recurrent or metastatic head and neck cancer

Immunotherapy with the anti-PD-1 antibody pembrolizumab (Keytruda) was effective in one out of four patients with recurrent or metastatic head and neck cancer, according to results presented at the 2015 meeting of the American Society for Clinical Oncology.

30 May 2015

FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

The U.S. Food and Drug Administration (FDA) has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company announced today. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog.

29 May 2015

Monoclonal antibody nivolumab improves survival rates of melanoma patients

The monoclonal antibody nivolumab has shown promise as a therapeutic agent, particularly by improving the survival rates of melanoma patients. Jeffrey S. Weber, M.D., Ph.D., director of the Donald A. Adam Comprehensive Melanoma Research Center at Moffitt Cancer Center will be presenting data from a retrospective analysis of the safety of nivolumab in 4 ongoing phase I-III studies in melanoma patients at the 2015 American Society of Clinical Oncology Annual Meeting in Chicago.

29 May 2015

Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Nektar Therapeutics reported today that partner Baxter International Inc. announced that the company has submitted a new drug application (NDA) to Japan's Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE [Antihemophilic Factor (Recombinant)] for patients over 12 years of age with hemophilia A.

From Baxter International Inc. 16 Apr 2015

Phase 2 IMAGO trial of SHP625 fails to meet primary endpoints in pediatric patients with ALGS

Shire plc today announced that the 13-week Phase 2 IMAGO trial of its investigational compound SHP625 (LUM001) did not meet the primary or secondary endpoints in the study of 20 pediatric patients with Alagille syndrome (ALGS), a rare, life-threatening genetic disorder that presents with chronic cholestasis (accumulation of bile acids in the liver) and severe pruritus (itching).

9 Apr 2015

New simeprevir clinical data to be presented at EASL's International Liver Congress 2015

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress 2015 of the European Association for the Study of the Liver taking place in Vienna from April 22-26.

8 Apr 2015

Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen today announced that the European Commission approved a new use of Vectibix (panitumumab) as first-line treatment in combination with FOLFIRI for the treatment of adult patients with wild-type (WT) RAS metastatic colorectal cancer (mCRC).

6 Apr 2015

Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced its plans for the commercialization of SPRIX (ketorolac tromethamine) Nasal Spray and OXAYDO (oxycodone HCI, USP) tablets for oral use only –CII.

25 Mar 2015

Egalet announces net revenues of $1.9 million for 2014

Egalet Corporation today reported financial results for the year ended December 31, 2014.

16 Mar 2015

Results of pacritinib Phase 2 study in myelofibrosis patients published in journal 'Blood'

CTI BioPharma Corp. today announced that results of a Phase 2 study of pacritinib, in patients with myelofibrosis were published in the journal Blood. Pacritinib is a next-generation oral JAK2/FLT3 multikinase inhibitor currently in Phase 3 development in the PERSIST program.

16 Mar 2015

Good news for patients suffering from shingles

The Journal of Drugs in Dermatology is delighted to present new findings from the Mayo Clinic's Department of Dermatology showing possible relief from the complications and pain secondary to Herpes Zoster, commonly known as shingles.

5 Mar 2015

Cipher acquires worldwide rights to three products from Astion

Cipher Pharmaceuticals Inc. today announced it has strengthened its product pipeline by acquiring the worldwide rights to three products from Astion Pharma, a Denmark-based specialty pharmaceutical company.

26 Feb 2015

FDA approves Fluzone Intradermal Quadrivalent vaccine to prevent four strains of influenza virus

Sanofi Pasteur, the vaccines division of Sanofi, today announced that the U.S. Food and Drug Administration has approved the supplemental biologics license application (sBLA) for Fluzone Intradermal Quadrivalent vaccine.

13 Dec 2014

Baxter seeks FDA approval of BAX 855 for treatment of people with hemophilia A

Nektar Therapeutics reported that partner Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the United States Food and Drug Administration for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].

From Baxter International Inc. 1 Dec 2014

Sanofi, Genzyme announce FDA approval of Lemtrada for treatment of relapsing forms of MS

Sanofi and its subsidiary Genzyme announced today that the U.S. Food and Drug Administration has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

17 Nov 2014

Vanda reports total revenues of $14.8 million for third quarter 2014

Vanda Pharmaceuticals Inc., today announced financial and operational results for the third quarter ended September 30, 2014.

27 Oct 2014

Regeneron, Sanofi announce initiation of dupilumab Phase 3 study in adults with atopic dermatitis

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD) that is not adequately controlled with topical AD medications.

20 Oct 2014

Elusys completes phase 3 clinical program of obiltoxaximab in healthy adult volunteers

Elusys Therapeutics, Inc., a biopharmaceutical company developing antibody therapies to treat infectious disease, today announced it has completed three phase 3 healthy adult volunteer safety studies of obiltoxaximab (ETI-204).

23 Sep 2014