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Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

Nektar Therapeutics reports Baxter International Inc. today announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], which met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm.

From Baxter International Inc. 22 Aug 2014

GSK announces availability of once-weekly Tanzeum in pharmacies throughout the U.S.

GSK today announced that once-weekly Tanzeum (albiglutide), a prescription injectable treatment for type 2 diabetes in adults, as an adjunct to diet and exercise, is now available in pharmacies throughout the U.S.

29 Jul 2014

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

25 Jul 2014

Regeneron, Sanofi report positive results from dupilumab Phase 2b study in moderate-to-severe AD

Regeneron Pharmaceuticals, Inc. and Sanofi today announced positive results from a Phase 2b dose-ranging study of dupilumab, an investigational therapy, in adult patients with moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema.

10 Jul 2014

UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

UCB, a global biopharmaceutical leader, and Dermira, Inc., a privately held US-based dermatology company, announced today that they have entered into an exclusive licensing agreement for the development and future commercialization of Cimzia (certolizumab pegol) in dermatology.

3 Jul 2014

Galderma's trifarotene molecule gets FDA Orphan Drug Designation for treatment of congenital ichthyosis

Galderma announces that the U.S. FDA granted Orphan Drug Designation status for the company's trifarotene molecule for the treatment of congenital ichthyosis. Based on this decision, Galderma plans to implement a clinical development plan, reinforcing its commitment to exploring new treatment options for rare diseases, as well as meeting the needs of all patients with skin diseases over the course of their lives.

2 Jul 2014

ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has approved LemtradaTM (alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

30 Jun 2014

Incyte’s ruxolitinib Phase III study for polycythemia vera achieves primary endpoint

Incyte Corporation (Nasdaq: INCY) today announced results from the RESPONSE trial, the first pivotal Phase III study evaluating a JAK1/JAK2 inhibitor for the treatment of polycythemia vera (PV).

4 Jun 2014

Amgen presents extended analysis of PEAK study data at ASCO

Amgen today announced results from the Phase 2 PEAK study that reinforce the improved overall survival (OS) benefit of panitumumab (Vectibix®) when used in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, compared to bevacizumab (Avastin) plus FOLFOX as first-line treatment in patients with wild-type RAS metastatic colorectal cancer (mCRC).

31 May 2014

FDA approves Takeda's Entyvio for severe active ulcerative colitis and Crohn's disease

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., has announced that the United States (U.S.) Food and Drug Administration (FDA) simultaneously approved a new biologic therapy, Entyvio™ (vedolizumab), for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD).

21 May 2014

OLYSIO (simeprevir) receives EC marketing authorisation for treatment of genotype 1 and 4 CHC

Janssen-Cilag International NV today announced that its next generation protease inhibitor (PI) OLYSIOTM (simeprevir) has been granted marketing authorisation by the European Commission (EC) for the treatment of adults with genotype 1 and 4 chronic hepatitis C (CHC), in combination with other medicinal products.

16 May 2014

Bristol-Myers Squibb announces study results of nivolumab drug in patients with renal cell carcinoma

Bristol-Myers Squibb Company today announced results from a Phase 2 and a Phase 1b study of its investigational PD-1 immune checkpoint inhibitor nivolumab in patients with advanced or metastatic renal cell carcinoma (RCC), commonly known as kidney cancer.

16 May 2014

Bristol-Myers Squibb reports updated survival data from Phase 1b study of advanced melanoma

Bristol-Myers Squibb Company today announced updated survival data from the advanced melanoma cohort of Phase 1b study.

16 May 2014

FDA approves Bayer's Kogenate FS antihemophilic factor VIII to prevent bleeding episodes in adults with hemophilia A

Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Bayer's Kogenate® FS antihemophilic factor VIII (recombinant), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

12 May 2014

Zoetis’ revenue increases $1.1B to 1% in first quarter 2014

Zoetis Inc. today reported its financial results for the first quarter of 2014. The company reported revenue of $1.1 billion for the first quarter of 2014, an increase of 1% from the first quarter of 2013. Revenue reflected an operational increase of 4%, with foreign currency having a negative impact of 3 percentage points.

6 May 2014

Bristol-Myers Squibb to present new immunotherapy study data at ASCO Annual Meeting

Bristol-Myers Squibb Company today announced that new data from studies investigating its immunotherapies in adjuvant and advanced melanoma, non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (mRCC) will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 30-June 3.

6 May 2014

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.

15 Apr 2014

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.

7 Apr 2014

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.

2 Apr 2014

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.

25 Mar 2014

Pruritus News and Research

Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

GSK announces availability of once-weekly Tanzeum in pharmacies throughout the U.S.

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Regeneron, Sanofi report positive results from dupilumab Phase 2b study in moderate-to-severe AD

UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

Galderma's trifarotene molecule gets FDA Orphan Drug Designation for treatment of congenital ichthyosis

ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

Incyte’s ruxolitinib Phase III study for polycythemia vera achieves primary endpoint

Amgen presents extended analysis of PEAK study data at ASCO

FDA approves Takeda's Entyvio for severe active ulcerative colitis and Crohn's disease

OLYSIO (simeprevir) receives EC marketing authorisation for treatment of genotype 1 and 4 CHC

Bristol-Myers Squibb announces study results of nivolumab drug in patients with renal cell carcinoma

Bristol-Myers Squibb reports updated survival data from Phase 1b study of advanced melanoma

FDA approves Bayer's Kogenate FS antihemophilic factor VIII to prevent bleeding episodes in adults with hemophilia A

Zoetis’ revenue increases $1.1B to 1% in first quarter 2014

Bristol-Myers Squibb to present new immunotherapy study data at ASCO Annual Meeting

Obeticholic acid meets primary composite endpoint in Phase III study

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

FDA approves ORALAIR sublingual allergy immunotherapy tablet

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

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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