Faslodex receives US FDA approval as monotherapy for expanded use in breast cancer

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August 28, 2017

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy.

Bristol-Myers Squibb and Daiichi Sankyo Announce Research Collaboration to Evaluate Opdivo® (nivolumab) and DS-8201 in HER2-Expressing Breast and Bladder Cancers

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August 28, 2017

Bristol-Myers Squibb Company and Daiichi Sankyo Company, Limited have announced a collaborative clinical trial to evaluate the combination of Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) and Daiichi Sankyo’s investigational antibody drug conjugate DS-8201 in HER2-expressing metastatic breast and urothelial (bladder) cancers.

Merck Announces Results of REVEAL Outcomes Study of Anacetrapib, Investigational Medicine for Cardiovascular Disease

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August 29, 2017

Merck, and researchers in the Clinical Trial Service Unit at the University of Oxford, have announced the publication and presentation of results from the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study of anacetrapib, Merck’s investigational cholesteryl ester transfer protein (CETP) inhibitor. In the study of 30,449 patients with atherosclerotic vascular disease receiving LDL-C lowering treatment with atorvastatin, anacetrapib significantly reduced the risk of major coronary events (composite of coronary death, myocardial infarction or coronary revascularization) by 9 percent relative to placebo (10.8% vs. 11.8%, respectively; P=0.004).

New Analysis Shows Repatha® (Evolocumab) Reduces Cardiovascular Events In Patients With History Of Stroke

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August 29, 2017

Amgen has announced that a new analysis showed lowering low-density lipoprotein cholesterol (LDL-C) levels with Repatha® (evolocumab) reduced the risk of cardiovascular events in a sub-group of patients with a history of stroke from the Repatha cardiovascular outcomes study (FOURIER). No new safety concerns were identified in this cohort of more than 5,000 patients. Detailed results were presented today in a Late-Breaking Clinical Trials session at the European Society of Cardiology (ESC) Congress 2017 in Barcelona, Spain.

AstraZeneca and Takeda establish collaboration to develop and commercialize MEDI1341 for Parkinson’s disease

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August 29, 2017

AstraZeneca and Takeda Pharmaceutical Company Limited have announced that they have entered an agreement to jointly develop and commercialise MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).

Bristol-Myers Squibb and Pfizer Alliance Announce Real-World Observational Analysis of the Effectiveness and Safety of Direct Oral Anticoagulants Compared to Warfarin in Elderly Patients with Non-Valvular Atrial Fibrillation

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August 29, 2017

Bristol-Myers Squibb Company and Pfizer Inc. have announced findings from a real-world data analysis of the U.S. Humana database, in which treatment with Eliquis ® (apixaban) was associated with a significantly lower risk of stroke/systemic embolism and lower rates of major bleeding compared to warfarin in patients aged 65 years and older with non-valvular atrial fibrillation (NVAF).

Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice

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August 30, 2017

Novartis has announced that the US Food and Drug Administration (FDA) has approved Kymriah(TM) (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer. Kymriah is the first therapy based on gene transfer approved by the FDA.

New Data for Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Demonstrate Durable Responses in Patients with Advanced Melanoma

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August 30, 2017

Incyte Corporation has announced that the European Society for Medical Oncology (ESMO) has published an abstract (#1214O) containing new and updated data from the ongoing Phase 1/2 ECHO-202 trial evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with the anti-PD-1 KEYTRUDA® (pembrolizumab), marketed by Merck & Co., in patients with advanced melanoma. Across all efficacy-evaluable advanced melanoma patients, median progression-free survival (PFS) was 12.4 months, with PFS rates of 70 percent, 54 percent, and 50 percent at 6 months, 12 months, and 18 months respectively. In patients who were treatment-naïve for advanced disease, median PFS has not been reached, with landmark PFS rates of 68 percent, 52 percent, and 52 percent at 6 months, 12 months, and 18 months respectively.

Long-Term Analysis of Phase 3 Head-To-Head Study Confirms KYPROLIS® (Carfilzomib) Regimen Extends Overall Survival in Patients With Relapsed Multiple Myeloma

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August 30, 2017

Amgen has announced positive results from a post-hoc analysis requested by the U.S. Food and Drug Administration (FDA) of the Phase 3 head-to-head ENDEAVOR trial, which followed patients for at least three years after enrollment. The analysis evaluated overall survival (OS) and long-term safety of KYPROLIS® (carfilzomib) administered at 56 mg/m2 twice weekly and dexamethasone (Kd) versus Velcade® (bortezomib) and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma. Kd reduced the risk of death by 24 percent over Vd (median OS 47.8 months for Kd versus 38.8 months for Vd, HR=0.76, 95 percent CI, 0.63-0.92; p=0.0017). This Kd regimen is currently approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival in the ENDEAVOR study.

FDA approves Roche’s Actemra/RoActemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome

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August 30, 2017

Roche has announced that the US Food and Drug Administration (FDA) has approved Actemra/RoActemra® (tocilizumab) intravenous injection for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older. CRS, which is caused by an overactive immune response, has been identified as a potentially severe and life-threatening side effect of CAR T cell therapy for certain cancers.

European Commission Approves Expanded Use of Mimpara® (Cinacalcet) For the Treatment of Secondary Hyperparathyroidism in Children with End-Stage Renal Disease on Dialysis

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Aug. 31, 2017

Amgen has announced that the European Commission (EC) has granted Marketing Authorization of a pediatric formulation (granules in capsule for opening) of Mimpara® (cinacalcet) for the treatment of secondary hyperparathyroidism (HPT) in children aged three years and older with end‑stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy.

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