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CORAL GABLES, Fla., May 10, 2017 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, today announced that an abstract highlighting the results of an investigator-sponsored Phase 2b study of Firdapse® (amifampridine phosphate) in the treatment of MuSK antibody positive myasthenia gravis (MuSK-MG) has been accepted for a scientific poster presentation at the 13th International Conference on Myasthenia Gravis and Related Disorders to be held on May 15-17, 2017 in New York. “The current pilot study with MuSK-MG patients showed measurable evidence of benefit in all the assessed outcome measures, despite the small sample size.  We feel these results are a strong signal that amifampridine phosphate can be a safe, effective treatment for the difficult to manage symptoms of MuSK-MG.  An expanded trial will seek to confirm the results presented in Dr. Mantegazza’s abstract,” said Gary Ingenito, M.D., Ph.D., Catalyst’s Chief Medical Officer. This study was conducted by a team of researchers led by Renato Mantegazza, MD and Silvia Bonanno, M.D., Department of Neuroimmunology and Neuromuscular Diseases, Fondazione Istituto Neurologico “Carlo Besta” in Milan, Italy, a major referral center for MuSK-MG patients. The poster presentation details are as follows: Title: “MuSK MG Patients Showed a Positive Response to Amifampridine Phosphate in a Randomized, Placebo-Controlled, Crossover Study” Poster Session: Day 1 Poster Session at Marriott Downtown, 85 West St., New York, NY 10280 Session Date/Time: May 15, 2017 from 6:00 to 8:30 PM Authors: Silvia Bonanno, M.D., Barbara Pasanisi, M.D., Carlo Antozzi, M.D., Lorenzo Maggi, M.D., Francesca Andreetta, Ph.D., Ornella Simoncini, MSc., and Renato Mantegazza, M.D. Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), MuSK antibody positive myasthenia gravis and infantile spasms. Firdapse® has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LEMS and Orphan Drug Designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS. Catalyst is also developing CPP-115 to treat refractory infantile spasms, and possibly refractory Tourette's Disorder. CPP-115 has been granted U.S. Orphan Drug Designation for the treatment of infantile spasms by the FDA and has been granted E.U. Orphan Medicinal Product Designation for the treatment of West syndrome by the European Commission.  In addition, Catalyst is developing a generic version of Sabril® (vigabatrin). This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including whether Catalyst can successfully design and complete a registration trial evaluating Firdapse for the treatment of MuSK-MG that is acceptable to the FDA, whether any such trial for the treatment of MuSK-MG that is acceptable to the FDA will be successful, whether Catalyst can obtain the funding required to conduct such a trial, and those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2016 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.


CORAL GABLES, Fla., May 10, 2017 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, today announced that an abstract highlighting the results of an investigator-sponsored Phase 2b study of Firdapse® (amifampridine phosphate) in the treatment of MuSK antibody positive myasthenia gravis (MuSK-MG) has been accepted for a scientific poster presentation at the 13th International Conference on Myasthenia Gravis and Related Disorders to be held on May 15-17, 2017 in New York. “The current pilot study with MuSK-MG patients showed measurable evidence of benefit in all the assessed outcome measures, despite the small sample size.  We feel these results are a strong signal that amifampridine phosphate can be a safe, effective treatment for the difficult to manage symptoms of MuSK-MG.  An expanded trial will seek to confirm the results presented in Dr. Mantegazza’s abstract,” said Gary Ingenito, M.D., Ph.D., Catalyst’s Chief Medical Officer. This study was conducted by a team of researchers led by Renato Mantegazza, MD and Silvia Bonanno, M.D., Department of Neuroimmunology and Neuromuscular Diseases, Fondazione Istituto Neurologico “Carlo Besta” in Milan, Italy, a major referral center for MuSK-MG patients. The poster presentation details are as follows: Title: “MuSK MG Patients Showed a Positive Response to Amifampridine Phosphate in a Randomized, Placebo-Controlled, Crossover Study” Poster Session: Day 1 Poster Session at Marriott Downtown, 85 West St., New York, NY 10280 Session Date/Time: May 15, 2017 from 6:00 to 8:30 PM Authors: Silvia Bonanno, M.D., Barbara Pasanisi, M.D., Carlo Antozzi, M.D., Lorenzo Maggi, M.D., Francesca Andreetta, Ph.D., Ornella Simoncini, MSc., and Renato Mantegazza, M.D. Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), MuSK antibody positive myasthenia gravis and infantile spasms. Firdapse® has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LEMS and Orphan Drug Designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS. Catalyst is also developing CPP-115 to treat refractory infantile spasms, and possibly refractory Tourette's Disorder. CPP-115 has been granted U.S. Orphan Drug Designation for the treatment of infantile spasms by the FDA and has been granted E.U. Orphan Medicinal Product Designation for the treatment of West syndrome by the European Commission.  In addition, Catalyst is developing a generic version of Sabril® (vigabatrin). This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including whether Catalyst can successfully design and complete a registration trial evaluating Firdapse for the treatment of MuSK-MG that is acceptable to the FDA, whether any such trial for the treatment of MuSK-MG that is acceptable to the FDA will be successful, whether Catalyst can obtain the funding required to conduct such a trial, and those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2016 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.


PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that more than 80 presentations, including 16 oral presentations and seven poster discussions, highlighting data from Company-sponsored studies, collaborations and investigator-sponsored research evaluating its oncology compounds across 20 types of cancer, will be featured at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 in Chicago from June 2-6. Results to be presented represent the breadth of the Company’s Oncology research portfolio, including monotherapy and combination studies of Opdivo (nivolumab) and Yervoy (ipilimumab), as well as studies of Empliciti (elotuzumab) and Sprycel (dasatinib). The Company will also present updates from its robust investigational pipeline, including proof-of-concept efficacy data for its anti-lymphocyte activation gene-3 (LAG-3) monoclonal antibody in combination with Opdivo and pharmacokinetic, pharmacodynamic and safety data on its investigational glucocorticoid-induced tumor necrosis factor receptor-related gene (GITR) agonist alone and for the first time, in combination with Opdivo in advanced solid tumors. Several presentations will report data from clinical collaborations supportive of the Company’s efforts to advance understanding of the potential role for Opdivo in combination with novel mechanisms of action for several tumor types, including the first presentation of data evaluating the safety and efficacy of Opdivo in combination with epacadostat, Incyte’s selective IDO1 enzyme inhibitor. Presentations featuring translational medicine research underscore Bristol-Myers Squibb’s scientific leadership in driving understanding of how a patient’s tumor biology can potentially guide treatment decisions. Data from research on the Company’s medicines to be presented during the meeting include: At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients. We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 35 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O/radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how patients’ individual tumor biology can be used as a guide for treatment decisions throughout their journey. We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice. The II-ON, formed in 2012, is a global peer-to-peer collaboration between Bristol-Myers Squibb and academia advancing the science of Immuno-Oncology (I-O) through a series of preclinical, translational and biology-focused research objectives. The research in the collaboration is focused on three fundamental scientific pillars: understanding the mechanisms of resistance to immunotherapy; identifying patient populations likely to benefit from immunotherapy; and exploring novel combination therapies that may enhance anti-tumor response through complementary mechanisms of action. The II-ON facilitates the translation of scientific research findings into drug discovery and development, with the goal of introducing new treatment options into clinical practice. In addition to Bristol-Myers Squibb, the II-ON currently comprises 15 leading cancer research institutions, including: Clinica Universidad Navarra, Columbia University Medical Center, Dana-Farber Cancer Institute, The Earle A. Chiles Research Institute (Providence Health & Services), Institut Gustave Roussy, Istituto Nazionale per lo Studio e la Cura dei Tumori “Fondazione G. Pascale”, Bloomberg-Kimmel Institute for Cancer Immunotherapy at the Johns Hopkins Kimmel Cancer Center, Memorial Sloan Kettering Cancer Center, National Cancer Center Japan, The Netherlands Cancer Institute, Peter MacCallum Cancer Centre, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, University College London, The University of Chicago and West German Cancer Center/University Hospital Essen. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union. OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose. OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 4.9% (13/263) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 3.4% (9/263) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=8). OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis. OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13% (51/407) of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%. In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported. OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia. In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO with YERVOY, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO with YERVOY, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes occurred in 1.5% (6/407) of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies. OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of patients. In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis. OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO with YERVOY (0.2%) after 1.7 months of exposure. Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO the following clinically significant immune-mediated adverse reactions occurred in <1.0% of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis, motor dysfunction, vasculitis, and myasthenic syndrome. OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients. In patients receiving OPDIVO with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients. Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT. Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly. Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO. It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose. In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, among all patients (safety population [n=263]), adverse reactions leading to discontinuation (4.2%) or to dosing delays (23%) occurred. The most frequent serious adverse reactions reported in ≥1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT. Serious adverse reactions occurred in 21% of patients in the safety population (n=263) and 27% of patients in the subset of patients evaluated for efficacy (efficacy population [n=95]). In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO. The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infections, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, among all patients (safety population [n=263]) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (≥20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%). In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥ 20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%). Checkmate 067 - advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 - advanced melanoma; Checkmate 017 - squamous non-small cell lung cancer (NSCLC); Checkmate 057 - non-squamous NSCLC; Checkmate 025 - renal cell carcinoma; Checkmate 205/039 - classical Hodgkin lymphoma; Checkmate 141 - squamous cell carcinoma of the head and neck; Checkmate 275 - urothelial carcinoma. Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY. About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan. Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 also is expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage. Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity. On November 30, 2015, the U.S. Food and Drug Administration (FDA) approved Empliciti in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received one to three prior therapies. On May 11, 2016, the European Commission approved Empliciti in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received at least one prior therapy. The safety and efficacy of Empliciti is being evaluated by other health authorities. Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities. EMPLICITI™ (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. Please see the full Prescribing Information for EMPLICITI. Sprycel was first approved by the FDA in 2006 for the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) who are resistant or intolerant to prior therapy including imatinib. At that time, Sprycel was also approved for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to prior therapy. Sprycel is approved and marketed worldwide for these indications in more than 60 countries. Sprycel is also an FDA-approved treatment for adults with newly diagnosed CP Ph+ CML (since October 2010). Sprycel received accelerated FDA approval for this indication. Additional country approvals for this indication total more than 50. SPRYCEL® (dasatinib) is indicated for the treatment of adults with: Treatment with SPRYCEL is associated with severe (NCI CTC Grade 3/4) thrombocytopenia, neutropenia, and anemia, which occur earlier and more frequently in patients with advanced phase CML or Ph+ ALL than in patients with chronic phase CML. Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities. SPRYCEL caused thrombocytopenia in human subjects. In addition, dasatinib caused platelet dysfunction in vitro. In all CML or Ph+ ALL clinical studies, ≥grade 3 central nervous system (CNS) hemorrhages, including fatalities, occurred in <1% of patients receiving SPRYCEL. Grade 3 or greater gastrointestinal hemorrhage, including fatalities, occurred in 4% of patients and generally required treatment interruptions and transfusions. Other cases of ≥grade 3 hemorrhage occurred in 2% of patients. SPRYCEL may cause fluid retention. After 5 years of follow-up in the randomized newly diagnosed chronic phase CML study (n=258), grade 3/4 fluid retention was reported in 5% of patients, including 3% of patients with grade 3/4 pleural effusion. In patients with newly diagnosed or imatinib resistant or intolerant chronic phase CML, grade 3/4 fluid retention occurred in 6% of patients treated with SPRYCEL at the recommended dose (n=548). In patients with advanced phase CML or Ph+ ALL treated with SPRYCEL at the recommended dose (n=304), grade 3/4 fluid retention was reported in 8% of patients, including grade 3/4 pleural effusion reported in 7% of patients. After 5 years of follow-up in the randomized newly diagnosed chronic phase CML trial (n=258), the following cardiac adverse events occurred: Monitor patients for signs or symptoms consistent with cardiac dysfunction and treat appropriately. SPRYCEL may increase the risk of developing PAH, which may occur any time after initiation, including after more than 1 year of treatment. Manifestations include dyspnea, fatigue, hypoxia, and fluid retention. PAH may be reversible on discontinuation of SPRYCEL. In vitro data suggest that dasatinib has the potential to prolong cardiac ventricular repolarization (QT interval). Cases of severe mucocutaneous dermatologic reactions, including Stevens-Johnson syndrome and erythema multiforme, have been reported in patients treated with SPRYCEL. TLS has been reported in patients with resistance to prior imatinib therapy, primarily in advanced phase disease. Based on limited human data, SPRYCEL can cause fetal harm when administered to a pregnant woman. Hydrops fetalis, fetal leukopenia and fetal thrombocytopenia have been reported with maternal exposure to SPRYCEL. Transplacental transfer of dasatinib has been measured in fetal plasma and amniotic fluid at concentrations comparable to those in maternal plasma. No data are available regarding the presence of dasatinib in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, dasatinib is present in the milk of lactating rats. SPRYCEL is a CYP3A4 substrate and a weak time-dependent inhibitor of CYP3A4. The safety data reflects exposure to SPRYCEL at all doses tested in clinical studies including 324 patients with newly diagnosed chronic phase CML and 2388 patients with imatinib resistant or intolerant chronic or advanced phase CML or Ph+ ALL. The median duration of therapy in all 2712 SPRYCEL-treated patients was 19.2 months (range 0–93.2 months). Median duration of therapy in: In the newly diagnosed chronic phase CML trial, after a minimum of 60 months of follow-up, the cumulative discontinuation rate for 258 patients was 39%. In the overall population of 2712 SPRYCEL-treated patients, 88% of patients experienced adverse reactions at some time and 19% experienced adverse reactions leading to treatment discontinuation. Among the 1618 SPRYCEL-treated patients with chronic phase CML, drug-related adverse events leading to discontinuation were reported in 329 (20.3%) patients. Among the 1094 SPRYCEL-treated patients with advanced phase CML or Ph+ ALL, drug-related adverse events leading to discontinuation were reported in 191 (17.5%) patients. Patients ≥65 years are more likely to experience the commonly reported adverse reactions of fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, and appetite disturbance, and more likely to experience the less frequently reported adverse reactions of abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary edema and weight decrease, and should be monitored closely. Please see the full Prescribing Information for SPRYCEL. Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook. This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that any of the oncology compounds mentioned in this release will receive regulatory approval for an additional indication. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.


News Article | May 17, 2017
Site: www.businessoffashion.com

VENICE, Italy — Let’s get lost. Throw away the map and wander. That’s always been Venice’s open invitation to visitors. It’s even more tempting when the city hosts its biannual art fair. The 57th edition opened to the public on Saturday and will run for the next six months. This time there are 85 national pavilions, which is why the Biennale is often referred to as the art world’s Olympics. Or maybe — given the glamorous palaver of the fair’s preview days last week — its Cannes. The main venues are the Giardini, the gardens originally laid out according to Napoleon’s masterplan for Venice, and the Arsenale, a massive converted naval warehouse, both at the top of the Grand Canal, but there are events and exhibitions all over the city, in magnificent palazzos, down any one-person-wide alleyway. You need to get lost — and also resign yourself to the fact that you can’t possibly see everything on offer. Last time I made it to the Biennale, the curator was wunderkind Massimiliano Gioni. His focus on the alternate realities created by artists — many of them working in alternate states, way outside the margins — was often mesmerising. The 57th is curated by Christine Macel, from the Centre Pompidou. She’s called it Viva Arte Viva, which could be loosely interpreted as referring to art plonked down in the middle of living. There was a whole lot of “real” life in the Giardini’s Main Pavilion, and in the Arsenale, where Macel divided her theme into nine “pavilions” populated by 120 artists from 51 countries. There were people sleeping, people making things, mending things, human industry on display. I particularly liked the Pavilion of Artists and Books: Geng Jianyi’s hand-bound books soaked in coloured ink, Abdullah al Saadi’s hand-lettered scrolls rolled up in old Twinings tea caddies, John Latham’s charred tomes. But I love books. Elsewhere, much of it felt like looking into someone’s workspace, messy, intimate, most engaging, maybe, if you were the actual artist. Among the many affinities shared by art and fashion, the most relevant is their ability to reflect their times, and project that reflection into some kind of prediction. Viva Arte Viva’s often humble emphasis on craft – there was fabric hanging everywhere, a literal expression of the artist’s hand at work – mirrored contemporary fashion’s preoccupation with the artisanal past, as a way to customise, to individualise a human response to the incomprehensible present. I guess it could be seen as a retreat into the reassurance of tradition, but the impulse is forward-looking, optimistic: I make, therefore I am. (In fashion terms, would that be, ‘I wear, therefore I am’?) It found much more visceral expression in the individual national pavilions. Mark Bradford, artist-in-residence for the United States, called his installation, "Tomorrow is Another Day," after Scarlett O’Hara’s hope-in-adversity battlecry at the end of "Gone With the Wind." Black, gay, nearly 7ft-tall in shoes, Bradford could scarcely do more to stand out in Trump’s America. Challenged to represent a country which he feels no longer represents him (as he already famously told the New York Times), he reconfigured the gleaming white, neo-classically columned, cupola-ed US pavilion, nicknamed the White House, as an eerie journey through darkness and decay to a final exultant video piece of a friend sashaying away from the camera down an LA street in white tank top and yellow shorts, hips swinging like Marilyn Monroe’s in the final scene of "Niagara" (Bradford’s inspiration for the video). A similar process — joy trumping pain and loss — made Geoffrey Farmer’s transfiguration of the Canadian pavilion a triumph. The building is in the process of being renovated so Farmer was able to gut it and turn the whole thing into one huge fountain. The genesis of the idea was a 1955 collision between a train and a lumber truck, which indirectly brought about the death of his grandfather. So Farmer’s fountain spectacularly spewed from a trompe l’oeil pile of planks, cast in metal. If its explosive violence evoked the accident, there was also the simple, transcendent rush of water, like fireworks in aquatic form. People got wet and didn’t care. Water squirted from everything in Farmer’s installation: a grandfather clock, a book, a folded duvet, a railroad track. Water is magical in Venice. On one late-night walk back to the hotel, a high tide, acqua alta, was washing across the Piazza San Marco. Women slipped off Louboutins and Viviers to walk barefoot to their water taxis. Surreal. The knee-high plastic waders flogged by street vendors instantly became the accessory of the moment. Equally surreal: Giorgio Andreotta Calo’s reflecting pond, an astonishing optical illusion in the Italian pavilion (appropriately called Il Mondo Magico). Fendi hosted a dinner to celebrate Il Mondo Magico at the Scuola Grande di San Rocco, where I was assured 70 of the world’s Tintoretto’s are to be found, including a massive, majestic "Crucifixion" which turned imperturbable gallerist Jay Jopling into a euphoric fanboy. The Venice effect! In a season when the industry’s biggest names have been making promotional moves that are more extravagant than ever (Dior’s LA and Louis Vuitton’s Kyoto Cruise shows happened while the Biennale was previewing), Venice still offers the worlds of fashion and design the grandest opportunities to impress their finer selves on the planet — or at least prove they are patrons quite the match of the Medicis. Until November, the Fondazione Prada, in the Ca’ Corner della Regina, is showing "The Boat is Leaking. The Captain Lied," a three-way collaboration between filmmaker Alexander Kluge, set designer Anna Viebrock and artist Thomas Demand, who cross-reference each other’s work across three floors. It might sound academic, but each floor opens into a blank lobby lined with doors, loaded with promise, which adds an element of play (literally, because most of them were taken from Viebrock’s stage designs). Behind Door Number One? Room after room so packed with art and ideas that it would take days to unpick them all. Miuccia Prada, in big sweater and skinny jeans, looked positively giddy with excitement as she guided visitors around the grand opening. I walked away fixated on a video of one of the environments Demand makes entirely from paper: an office with everything sliding relentlessly backwards and forwards, like those CCTVs filmed during earthquakes in Japan. But I also loved the roomful of gloomy paintings by 19th century Milanese artist Angelo Morbelli. Never heard of him, but now I’m a rabid fan. More of that Venice effect. The other grand fashion patron in Venice is Francois Pinault, chairman of Gucci’s parent Kering. This year, he is responsible for the elephant in the Biennale’s room. Though it’s not part of the fair itself, Damien Hirst’s giant show "Treasures from the Wreck of the Unbelievable" was the polarising talking point of the preview days. His re-imagination of the trove retrieved from a wealthy collector’s ship submerged for two thousand years fills both Pinault’s exhibition spaces, the Punta della Dogana, the old customs house, and the Palazzo Grassi on the Grand Canal. Its sheer scale is just one of the reasons why it has inflamed purist art world sensibilities — and why it will enthrall just about everyone else this summer. The three-story-high bronze god (resin, actually) in the courtyard of the Grassi is enough to render resistance futile. Even a churl couldn’t deny the degree of craft (ten years’ work by 250 craftsmen in five countries) or the quality of materials: the Buddha sculpted from one single massive block of jade, the Medusa carved from a piece of gorgeously lurid green malachite, a mineral so toxic the sculptor must wear gloves. That particular piece alone required three years of work. There were some things to love (four bronze lizards on a rock? I’ll take that!), a hell of a lot to admire, and some things — like the fake coral — that were eventually much too much. I walked away awed by the protean obsession of the artist — and wondering what would remain if you were to submerge a contemporary equivalent of his “ancient” collection for another two thousand years. Not much, I’d imagine. Maybe that was a telling acknowledgement of the impermanence of the digital world we’re so busy creating. Nothing lasts forever, now more than ever. And why would you want it to? Unless you’re the Belgian collector/aesthete Axel Vervoordt, who curates his last show at the Palazzo Fortuny this year. It’s called "Intuition": "When the body functions spontaneously, that is called instinct. When the soul functions spontaneously, that is called intuition." This particular palazzo is one of Venice’s most atmospheric, ripe with shadowy, velvety decadence, and Vervoordt has always done it full justice with his absorbing hybrids of antiquity and modernity: fetish objects from 6000BC sharing space with a mystical interactive piece by Ann Veronica Janssens from 2017 which utilises steam. Again, the magic of water. The very old and the very new work together in Venice in ways that would be confusing anywhere else. The density of the place, layer forced on layer, with the water always lapping at the door, made reconciliation of past, present and future a matter of survival. On my last night, I had dinner at the Aman, once the Palazzo Papadopoli, named for the Greek family who lived there in the 19th century. Earlier owners included the Tiepolo family (one ceiling was allegedly painted by the master Tiepolo). The walls are still Baroque damask, but now, the furniture is low-slung leather by B&B Italia. It’s an absolute culture clash but it’s Venice — and Italy — and both elements have such integrity that they co-exist quite comfortably. That is one reason the city has been able to absorb the Biennale, and foster it for decades. It might seem to be counter-intuitive to embrace the notion of never quite knowing how to get where you’re going. But Venice makes a fog of ignorance a delight. When the fog lifts, you’re in heaven. And then you go back to the start, and get lost again. How LACMA’s Art + Film Gala Became ‘the Met Ball of the West’


News Article | May 8, 2017
Site: www.businessoffashion.com

MILAN, Italy — This resort season is air miles madness for the hardy few prepared to chase fashion shows across the globe. Miuccia Prada opted for intelligent restraint. She showed at home, in Milan, but her choice of venue was so extraordinary and the bolt-on – an evening at the Fondazione Prada with Francesco Vezzoli’s new show "TV70" - so stimulating, that I doubt there was a soul who missed the experiential thrill of a far-off land. Miuccia presented five floors above the original Prada shop in the Galleria Vittorio Emanuele II, one of the world’s grandest – and oldest – malls (150 years-plus, if you’re counting). We looked out over the rusted industrial bones of the dome and the arcade, a vantage point so rare it was enough to make you feel like the Phantom alone in his opera house. And all that metallic, masculine grandiosity seemed to provoke Miuccia to new heights of spiky femininity. Pink and pastel, feathers and crystal, scalloped hems of lace on filmy lingerie, delicate layers of transparency…she’d expressed ambiguous feelings about these traditional tokens of seduction after her collection in February, but the world continues to change at warp speed, and the impulse to co-opt and subvert, always an impetus in Miuccia’s work, can only have grown stronger. She said she’d been thinking about modernism before she decided to show in the Galleria, a building which was, in its day, the elegant apogee of modernist architecture. Once the venue was chosen, she set out to marry that modernist elegance to the spirit she isolated as its contemporary equivalent in fashion: the lean, active, body-conscious essence of sportswear. But we are talking about Prada here, so the marriage was consummated under a topsheet of tantalizing perversity. Frederic Sanchez’s soundtrack used snippets from Francis Lai’s score for David Hamilton’s 1977 scandal-fest "Bilitis." The soft-focus eroticism of that movie was reflected in a collection which luxuriated in a Lolita-like prettiness. Kate Moss in the first flush of her career came to mind: the feathered headbands, the pigtails, the provokingly sheer layers designed to exercise Prudence McPrude, the Mayoress of Prudie Town. Longtime Prada collaborator James Jean contributed an art nouveau graphic of frolicking bunnies. It could have been cute, but Miuccia Prada doesn’t do cute. The kick in this collection was the sport. The first look – a black hoodie with Elizabethan sleeves over a sheer black skirt over a white slip and schoolgirl kneesocks with Chicklet and Concetta heels – was a virtual manifesto. Beauty with balls. And so it went on, a fabulously feisty female fuck-you to the world of old white men who go on grabbing at headlines with their self-aggrandising last gasps. There was a moment, not so long ago, when the Prada mojo went AWOL. On Sunday, that moment was a distant memory.


News Article | April 18, 2017
Site: www.cnet.com

Wondering what the first Mexican director to be nominated for both an Academy Award and Directors Guild of America award for directing has been up to lately? He's been setting even more records. Alejandro Iñárritu's short film, "CARNE y ARENA (Virtually present, Physically invisible)" is the first VR project to be chosen for the Official Selection of the Cannes Film Festival. It will be a six and a half minute solo experience, premiering ahead of its official opening in June at the Fondazione Prada in Milan. Emmanuel Lubezki, Iñárritu's cinematographer extraordinaire for "Birdman" and "The Revenant," is onboard. You can almost hear the movie buffs whooping. The film isn't so joyous, exploring the personal stories of refugees. "During the past four years in which this project has been growing in my mind, I had the privilege of meeting and interviewing many Mexican and Central American refugees," Iñárritu said in a statement. "Their life stories haunted me, so I invited some of them to collaborate with me in the project." Recently another critically-acclaimed director stepped onboard the VR plane: Ridley Scott announced RSA VR, an imprint of his production company that will be dedicated to mixed media. VR has been touted as the next big thing by important tech figures such as Facebook CEO Mark Zuckerberg and Google CEO Sundar Pichai. Here's hoping these filmmakers help it take off.


News Article | May 4, 2017
Site: www.prnewswire.co.uk

The specific research program which FPT Industrial is supporting through grant money focuses on diesel and natural gas engine combustion and after treatment systems. It is expected to run up to 2019. The announcement was made this morning at a presentation held in the University's Aula Magna in the presence of Annalisa Stupenengo, Brand President of FPT Industrial, Ferruccio Resta, Rector of Politecnico di Milano, and Gianantonio Magnani, President of Fondazione Politecnico di Milano and PoliHub. "The opportunity to collaborate with a center of such technological excellence and research as Politecnico di Milano is an opportunity to take part in the growth of those professional skills that in the future will contribute to allowing us to overcome market challenges," said Annalisa Stupenengo, Brand President of FPT Industrial. "FPT Industrial, Politecnico di Milano and its Foundation have already collaborated closely for many years. The goal once again is to make this opportunity a concrete and useful chance for both the students of the Polytechnic University, who undergo a training period in a business context, and for FPT Industrial itself, which confirms its ongoing commitment to supporting research." "Strengthening the collaboration links with big entrepreneurial realities has always been one of the goals of Politecnico di Milano," commented Ferruccio Resta, Rector of Politecnico di Milano, "a great technological university like ours is the ideal place to develop synergies, enhancing both academic and entrepreneurial talents. Partnerships such as those with FPT Industrial have important implications also in the innovation of a strategic sector for our country as for industrial engines." "Fondazione Politecnico di Milano has been working for almost 15 years to make the relationship between the university and companies closer and stronger," said Gianantonio Magnani, President of the Fondazione Politecnico di Milano and PoliHub, the incubator of Politecnico di Milano, "the collaboration with FPT Industrial, which is renewed today thanks to a new agreement, testifies that a common vision between research and enterprise is the real engine of innovation. It is a path of confidence which responds to market needs and the challenges posed by the environment." The project's activities will be coordinated by FPT Industrial (through its Research and Development Centers in Turin, Italy, and Arbon, Switzerland) and conducted in collaboration with the staff of the Energy Department of Politecnico di Milano, in particular, with the research teams of the ICE Group (Internal Combustion Engine) and the LCCP Group (Laboratory of Catalysis and Catalytic Processes). CNH Industrial N.V. (NYSE: CNHI /MI: CNHI) is a global leader in the capital goods sector with established industrial experience, a wide range of products and a worldwide presence. Each of the individual brands belonging to the Company is a major international force in its specific industrial sector: Case IH, New Holland Agriculture and Steyr for tractors and agricultural machinery; Case and New Holland Construction for earth moving equipment; Iveco for commercial vehicles; Iveco Bus and Heuliez Bus for buses and coaches; Iveco Astra for quarry and construction vehicles; Magirus for firefighting vehicles; Iveco Defence Vehicles for defence and civil protection; and FPT Industrial for engines and transmissions. More information can be found on the corporate website: www.cnhindustrial.com Sign up for corporate news alerts from the CNH Industrial Newsroom: bit.ly/media-cnhindustrial-subscribe


ATLANTA--(BUSINESS WIRE)--Nel 2016 la Fondazione Coca-Cola e The Coca-Cola Company hanno donato complessivamente più 106 milioni di dollari a oltre 230 organizzazioni. Tali contributi andranno direttamente a favore della collettività in più di 200 Paesi e territori, ove approssimativamente il 97 per cento delle sovvenzioni è stato destinato alle cause cui The Coca-Cola Company attribuisce priorità, ossia donne, risorse idriche e benessere collettivo.


News Article | February 20, 2017
Site: phys.org

Michelangelo Pistoletto is acknowledged as one of the founding fathers of the Italian Arte Povera contemporary art movement and is widely regarded as one of the most influential artists of his generation. The Arte Povera movement grew throughout Italy between the end of the 1960s and the beginning of the 1970s. Literally meaning 'poor art', this vivid art movement is characterised by its use of found and unconventional materials. Pistoletto's work mainly deals with the subject of the unification of art and everyday life, and his ongoing 'Third Paradise' project, conceived in 2003, envisions a third 'realm' that merges natural and artificial worlds and a society living in harmony with nature. Pistoletto began his cooperation with ESA for the development of the official mission patch of Paolo Nespoli's VITA mission, which includes the artist's symbol of his Third Paradise concept in the artwork designed by ESA for ASI, the Italian space agency. A natural continuation of this cooperation is the brand-new 'Spac3' app, which will allow users to select and combine Paolo's images from space with their own photos. Developed by ESA and ASI in close cooperation with RAM radioartemobile and Cittadellarte-Fondazione Pistoletto, the app will be launched at the same time as Paolo's launch into space later this year. As a user of this Spac3 app, you'll be able to receive the photos taken by Paolo during his mission and then you'll be invited to generate a new image based on six different themes inspired by the UN's sustainable development goals. These themes are: Life on land; Good health and wellbeing; Industry, innovation and infrastructure; Climate action; Life below water, and Sustainable cities and communities. Focusing on one of those themes, you'll create a unique and personal image that is an original combination of Paolo's space image and your Earth-based one. Your combination will be shaped into the Third Paradise symbol and then published as part of a larger interactive artwork by Pistoletto. The VITA mission, provided by ASI through a barter agreement with NASA, will be Paolo's third spaceflight when he is launched later this year as flight engineer on Expeditions 52/53. Paolo's first spaceflight was the two-week Esperia mission on the Space Shuttle STS-120 in 2007. He returned to the Station in 2010 for ESA's 160-day MagISStra mission as part of Expeditions 26/27. Explore further: Vita: next Space Station mission name and logo

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