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

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. [More]
Baxter seeks FDA approval of BAX 855 for treatment of people with hemophilia A

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)]. [More]
Sanofi, Genzyme announce FDA approval of Lemtrada for treatment of relapsing forms of MS

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. [More]
Vanda reports total revenues of $14.8 million for third quarter 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. [More]
Regeneron, Sanofi announce initiation of dupilumab Phase 3 study in adults with atopic dermatitis

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. [More]
Elusys completes phase 3 clinical program of obiltoxaximab in healthy adult volunteers

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). [More]
Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

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

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

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). [More]
Regeneron, Sanofi report positive results from dupilumab Phase 2b study in moderate-to-severe AD

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. [More]
UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

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. [More]
Galderma's trifarotene molecule gets FDA Orphan Drug Designation for treatment of congenital ichthyosis

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. [More]
ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

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. [More]
Incyte’s ruxolitinib Phase III study for polycythemia vera achieves primary endpoint

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). [More]
Amgen presents extended analysis of PEAK study data at ASCO

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). [More]
FDA approves Takeda's Entyvio for severe active ulcerative colitis and Crohn's disease

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

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

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

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

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. [More]