Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 335

Posts Tagged ‘spectrum’

Spectrum Pharmaceuticals Provides Pipeline Update on Late Stage Programs

Posted by fidest press agency su mercoledì, 1 gennaio 2020

Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today reported that its pre-specified primary endpoint in its Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations was not met in Cohort 1. The company also announced that the Biologics License Application (BLA) for ROLONTIS®(eflapegrastim) was accepted for review by the U.S. Food and Drug Administration (FDA) and set a Prescription Drug User Fee Act (PDUFA) date of October 24, 2020.The ZENITH20 trial’s Cohort 1 enrolled a total of 115 patients who received 16 mg/day of poziotinib. The intent-to-treat analysis showed that 17 patients had a response (by RECIST) and 62 patients had stable disease for a 68.7% disease control rate (DCR). The confirmed objective response rate (ORR) was 14.8% (95% Confidence Interval (CI) 8.9%-22.6%). The median duration of response was 7.4 months. The safety profile was in-line with othersecond-generation EGFR tyrosine kinase inhibitors.Joe Turgeon, President and CEO of Spectrum Pharmaceuticals said, “While the response rate of Cohort 1 in this trial was lower than we expected, the positive signals observed for this cohort provide support for the continued clinical evaluation of poziotinib in this patient population with significant unmet medical need. We look forward to providing read outs from Cohorts 2 and 3 in 2020, and plan to provide an update on the overall program strategy during the first quarter of 2020 after a full evaluation of the data from Cohort 1 is completed.”The ZENITH20 trial is made up of 7 independent cohorts. Cohorts 1 – 4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Cohorts 5 – 7 are exploratory studies. The futility analysis has been completed for Cohorts 2 and 3 which met their minimum threshold of responses to continue. The company expects to report results for these cohorts in 2020. Cohorts 4, 5, 6 and 7 are continuing per protocol.

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Oncology therapies

Posted by fidest press agency su lunedì, 9 settembre 2019

Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, is developing poziotinib in non-small cell lung cancer (NSCLC) EGFR exon 20 mutations and beyond. New clinical data from the poziotinib Phase 2 investigator-initiated trial in NSCLC EGFR exon 20 mutations, conducted by the University of Texas MD Anderson Cancer Center will be presented during the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer taking place in Barcelona, Spain from September 7-10, 2019. “There continues to be investigator interest in poziotinib’s unique characteristics to address NSCLC mutations, including exon 20 and other mutations, which have limited or no treatment options,” said Francois Lebel, M.D., F.R.C.P.C., Chief Medical Officer of Spectrum Pharmaceuticals. “The data presented at this conference by our scientific collaborators at MD Anderson further expands the body of evidence supporting poziotinib’s role in lung cancer and helps us gain new insights into its full potential.”

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Spectrum Pharmaceuticals Announces the Completion of the Sale of its Marketed Portfolio

Posted by fidest press agency su mercoledì, 6 marzo 2019

Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today completed the sale of its portfolio of seven FDA-approved hematology/oncology products to Acrotech Biopharma L.L.C., a step-down subsidiary of Aurobindo Pharma Limited, India.“The completion of this sale marks a significant pivot point in Spectrum’s history as we focus our efforts on our two promising late stage assets, ROLONTIS® and poziotinib,” stated Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “This transaction puts us in a strong capital position for the next chapter of our growth.”Under the terms of the agreement, Acrotech will make a $158.8 million up-front cash payment which represents the original payment of $160 million less certain purchase price adjustments for certain R&D activities. In addition, the company is eligible to receive up to $140 million in milestone payments. Spectrum has also reduced its staff by approximately 40 percent with the majority of impacted staff transitioning to Acrotech. Spectrum has retained a core group of commercial leadership talent to launch ROLONTIS® and poziotinib.The seven products included in the sale are: FUSILEV® (levoleucovorin), FOLOTYN® (pralatrexate injection), ZEVALIN® (ibritumomab tiuxetan), MARQIBO® (vinCRIStine sulfate LIPOSOME injection), BELEODAQ® (belinostat) for injection, EVOMELA® (melphalan) for injection, and KHAPZORYTM (levoleucovorin).Jefferies LLC acted as exclusive financial advisor to Spectrum. Paul Hastings LLP acted as exclusive legal counsel to Spectrum.

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Quadrant Biosciences to Collaborate on Signature Study of Minocycline Treatment of Autism Spectrum Disorder

Posted by fidest press agency su sabato, 27 ottobre 2018

Quadrant Biosciences, Inc., an emerging life science company based in Syracuse, N.Y., today announced its collaboration with the Autism Speaks® Autism Treatment Network (ATN) and its university research partners on research into the treatment of autism spectrum disorder (ASD). The ATN is a collaboration of Autism Speaks and some of the finest children’s hospitals and academic institutions in North America, specializing in multi-disciplinary medical care for children with autism. This Signature Study, including researchers from the Cincinnati Children’s Hospital Medical Center, University of Pittsburgh, and University of Missouri, is looking at the treatment of autism symptoms with the antibiotic minocycline. In addition to providing financial support for this important study, Quadrant Biosciences will be collecting salivary RNA data to further its work on epigenetic factors associated with ASD.Prompted by earlier studies, researchers at the Cincinnati Children’s Hospital Medical Center initiated a study looking at the effects of minocycline treatment on ASD symptoms.
Given these characteristics, animal researchers hypothesized that minocycline treatment would improve autism symptoms, and indeed this was the case. Researchers saw improvement in many classic autism symptoms such as aberrant social interaction, exploratory behavior, locomotion, and anxiety behaviors in various mouse models of ASD treated with minocycline. Additionally, trials in humans with Fragile X Syndrome-associated ASD have demonstrated improvement on the Clinical Global Impression Improvement subscale. These compelling results prompted the initiation of the present Autism Speaks ATN Signature Study.
The Autism Speaks ATN research also received support through the ATN’s role as the federally funded Autism Intervention Research Network for Physical Health. The clinical trial to begin later this year will involve a 24-subject, double-blind, placebo-controlled, four-week crossover study of minocycline in youths with ASD ages 12 to 22 years. The study aims to: 1) Determine if minocycline use will be associated with reduction in elevated EEG gamma power in persons with ASD compared to placebo; 2) assess the short-term safety and tolerability of minocycline in youths with ASD; and 3) better understand the efficacy and dosage of minocycline for the short-term treatment of memory, social gaze, psychophysical markers, attentional impairments, quality of life, and other concerns in adolescents with ASD.
The study includes well-regarded researchers in the autism field including Craig A. Erickson, M.D., Professor, Division of Child and Adolescent Psychiatry, and Logan Wink, Associate Professor, Cincinnati Children’s Hospital Medical Center; David Beversdorf, M.D., Professor of Neurology, Radiology, and Psychology, Thompson Center for Autism & Neurodevelopmental Disorders, University of Missouri; and Benjamin Handen, Ph.D., Professor of Psychiatry, Pediatrics, Psychology, and Education, University of Pittsburgh.

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Spectrum Brands Holdings to Report Fiscal 2018 Second Quarter

Posted by fidest press agency su venerdì, 13 aprile 2018

Spectrum Brands Holdings, Inc. (NYSE: SPB), a global consumer products company offering a portfolio of leading brands providing superior value to consumers and customers every day, announced today it will release its fiscal 2018 second quarter financial results for the period ended April 1, 2018 before the markets open on Thursday, April 26.
Spectrum Brands will conduct a live conference call and live webcast on April 26 at 9:00 a.m. Eastern Time (8:00 a.m. Central Time) to be hosted by Andreas Rouvé, Chief Executive Officer, and Doug Martin, Executive Vice President and Chief Financial Officer.To access the live audio conference call, U.S. participants may call 877-556-5260 and international participants may call 973-532-4903. The conference call ID number is 9059617. A live webcast and related presentation slides will be available by visiting the Event Calendar page in the Investor Relations section of Spectrum Brands’ website at http://www.spectrumbrands.com. A replay of the live webcast also will be accessible through the Event Calendar page in the Investor Relations section of the Company’s website.

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GSMA: Mobile Spectrum and Tax Reforms Needed to Remove Barriers to Bangladesh’s Vision 2021 Goals

Posted by fidest press agency su sabato, 7 aprile 2018

The GSMA today released a new report outlining the rapid growth of the Bangladesh mobile industry over the last decade, which now places it as the fifth largest mobile market in Asia Pacific. The GSMA Intelligence country overview also highlights some of the obstacles that may hinder the government’s efforts to achieving its Vision 2021 goals, including affordability of mobile services, taxation and spectrum pricing. Complementing this study, the GSMA also released the findings of a report it commissioned from EY on the potential economic impact of tax reform on the Bangladesh mobile industry.
“It’s clear that the mobile industry plays a crucial role in supporting the achievement of the government’s Vision 2021 and Digital Bangladesh initiatives, as well as the UN Sustainable Development Goals (SDGs). Mobile technology has and will continue to have a positive impact on the people of Bangladesh, and can accelerate Bangladesh’s progress as a digital society,” said Alasdair Grant, Head of Asia Pacific for the GSMA. “The country still faces a significant digital divide however, and steps must be taken to enable the right conditions for mobile internet connectivity to flourish in Bangladesh.” With 85 million unique mobile subscribers as of the end of 2017, more than half the country’s citizens now have access to essential services. However, despite 3G networks covering 93 per cent of the Bangladeshi population, mobile internet uptake is still low, at 21 per cent in 2017. Prioritising efforts to overcome barriers to adoption, such as network quality, availability of spectrum at affordable prices, taxation, affordability of services, lack of usability and skills, and locally relevant content, will be key to closing the digital access gap.

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Spectrum Pharmaceuticals Announces Leadership Changes

Posted by fidest press agency su martedì, 19 dicembre 2017

Natali a New York (2)New York. Spectrum Pharmaceuticals, Inc. (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced that its Board of Directors has terminated Rajesh C. Shrotriya, MD without cause from his position as Chief Executive Officer, and announced leadership changes under which Joseph W. Turgeon, the current President and Chief Operating Officer, has been named President and Chief Executive Officer and elected to the Board of Directors, and current Director Stuart M. Krassner, ScD, PsyD, has been named Chairman of the Board. In addition, Thomas J. Riga, who currently serves as Executive Vice President, Chief Commercial Officer and Head of Business Development, has been named Chief Operating Officer. These changes are effective immediately.Mr. Turgeon brings more than 30 years of experience in the pharmaceutical industry, including various executive leadership roles at Amgen Inc. He had served as Spectrum’s President and Chief Operating Officer since April 2014, and had previously served as the Company’s Senior Vice President and Chief Commercial Officer from October 2012 to April 2014. Prior to joining Spectrum, Mr. Turgeon spent 22 years at Amgen Inc. as Vice President of Sales.
Mr. Riga brings over 15 years of pharmaceutical sales and management experience in various positions at Amgen, Eli Lilly and Dendreon, including as Vice President of Sales at Dendreon. He had served as Spectrum’s Executive Vice President, Chief Commercial Officer and Head of Business Development since June 2017, and previously served as Spectrum’s Senior Vice President and Chief Commercial Officer from August 2014 to June 2017, and Vice President, Corporate Accounts from July 2013 to August 2014.
Dr. Krassner has served as a director of Spectrum since December 2004, and was previously a member of Spectrum’s Scientific Advisory Board from 1996 to 2001. Dr. Krassner’s career spans nearly four decades of experience in positions of increasing responsibility at the University of California at Irvine, most recently as Professor of Developmental and Cell Biology at the School of Biological Sciences. Dr. Krassner is Professor Emeritus, University of California, Irvine and has also been retained by pharmaceutical, medical device and other companies, including Allergan Pharmaceuticals, Lasermed Corporation, Automated Microbiology Systems, and In Vitro International, among others, to provide scientific and regulatory advisory services, including FDA compliance. He is a past member of the American Academy for the Advancement of Sciences, and the American Society of Tropical Medicine and Hygiene, among others.

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Offer Waterman present Diarmuid Kelley

Posted by fidest press agency su martedì, 7 gennaio 2014

Caravaggio - Ecce HomoBetween 24th January and 28th February 2014, leading Modern British and Contemporary art gallery, Offer Waterman, will host a major solo exhibition of new works by Diarmuid Kelley. Kelley is one of the UK’s leading portrait artists with work in the collections of The National Portrait Gallery and Chatsworth House to name a few.What separates Kelley from other portrait artists of today is his obsession with light. Inspired by the European painters of candlelit scenes – from Caravaggio’s theatrical drama to Vermeer’s ethereal interiors – Kelley produces beautifully constructed portraits that are timeless in their appeal. In order to precisely control the quality of light that enters his studio, Kelley has recreated the methods used by Joseph Wright of Derby. A small, enclosed room is built within the corner of his studio with a window frame on one side exposed to daylight whilst the other sides are curtained. The structure allows him to manipulate the amount of light within his compositions and ultimately achieve the dramatic, evocative works he is now renowned for.Most frequently, Kelley uses friends as models to form a broad spectrum of faces that reappear in paintings, including actress Olivia Williams, who has been cast in roles ranging from Regency beauty to contemporary femme fatale and who has been his muse for many years. In addition to these generic portraits Kelley also undertakes a limited number of portrait commissions including Dame Anne Owers (Her Majesty’s Chief Inspector of Prisons) whose portrait is now part of The National Portrait Gallery’s permanent collection.

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Spectrum Dynamics

Posted by fidest press agency su lunedì, 20 aprile 2009

Orangeburg, N.Y. Spectrum Dynamics announced today that it has recently closed on a round of new financing. The financing came from institutional and private investors, and will provide the necessary capital to realize both its short and long term strategic plans.  “This new capital, coupled with the recent approvals to sell the D-SPECT in Canada and Europe will provide Spectrum with a significant platform for growth,” stated James Haisler, CEO of Spectrum Dynamics.  “Spectrum Dynamics has primarily focused on only a small component of the U.S. market with a very specific product. Having these funds will allow the company to increase its sales footprint both in and outside the U.S. as well as bring new products to market that will appeal to a broader range of customers,” said Josh Gurewitz, VP of Sales and Marketing. http://www.spectrum-dynamics.com.  Spectrum Dynamics, with offices in New York, California and research and development facilities in Haifa, Israel, is a pioneering medical device company focused on personalized molecular imaging and applications. Spectrum Dynamics will revolutionize the practice of nuclear cardiology, and eventually all nuclear medicine applications, by dramatically enhancing workflow and providing new clinical applications not possible with conventional technology. Additional http://www.spectrum-dynamics.com.

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