Rofecoxib

Janet Woodcock, a top Food and Drug Administration official who had been on the short list to head the agency under President Joe Biden, will retire in early 2024 after 37 years at the regulator.Her retirement, first reported by Endpoints, was announced in an agency-wide message from Commissioner Robert Califf.A legend in every sense of the word, Janet has made an indelible mark on so many of us, and on public health, the announcement read. There isnt enough space or time here to properly capture her accomplishments, sing her praises, and most of all, thank her.Woodcock had served as acting commissioner at the beginning of the Biden administration until Califf assumed office in February 2022. At one time she was seen as a leading candidate to assume the full-time commissioners role, but some senators opposed her over her role in approving opioid painkillers while heading the FDAs drug review branch.During her tenure as acting FDA commissioner, the agency also signed off on the Alzheimers disease drug Aduhelm, despite the conflicting evidence presented by its developer, Biogen, in support of approval, as well as negative opinions from the agencys own statisticians and outside advisers.The decision was reminiscent of another approval that was made while Woodcock was head of the FDAs Center for Drug Evaluation and Research: the controversial call to approve Sarepta Therapeutics Duchenne muscular dystrophy drug Exondys over a negative vote from expert advisers convened to review that drug.Woodcock joined the FDA in 1986, first having several roles at the agencys Center for Biologics Evaluation and Research, which regulates vaccines, blood products and products derived from living tissues like cell and gene therapies. In 1994, she joined the drug evaluation and review division as director. During her time there, dozens of drugs gained approval that have extended patients lives or helped them control symptoms, while others, like the pain reliever Vioxx and the diabetes pill Avandia, proved to be unsafe.In 2004, she joined the commissioners office, serving as deputy commissioner, chief medical officer and chief operating officer. She returned to drug evaluation in 2007, where she served until the COVID-19 pandemic. She moved to the White Houses Operation Warp Speed, where she was in charge of evaluating therapeutics to treat COVID-19 infections.Since Califf assumed the commissioners position, Woodcock has served as his principal deputy commissioner. '

Company will also host a virtual analyst and investor event on November 13, 2023 PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it will present new Phase 2 clinical data from the ongoing SHASTA-2 and MUIR studies of plozasiran (ARO-APOC3) and the ARCHES-2 study of zodasiran (ARO-ANG3) at the American Heart Association (AHA) Scientific Sessions 2023, being held in Philadelphia on November 11-13, 2023. The company will also host a virtual analyst and investor event on November 13, 2023, at 4:30 pm ET featuring key opinion leaders who will discuss these data and their relevance as potential treatments for severe hypertriglyceridemia and mixed dyslipidemia in patients with atherosclerotic cardiovascular disease (ASCVD). To register for the event, please visit: . Details about the AHA presentations are listed below. American Heart Association (AHA) Scientific Sessions 2023 – November 11-13, 2023 Title: ARO-APOC3, an Investigational RNAi Therapeutic, Silences APOC3 and Reduces Triglycerides to Near Normal Levels in Patients With Severe Hypertriglyceridemia: SHASTA-2 Study Results Date/Time: November 13, 2023, 9:45 a.m. EST Presenter: Daniel Gaudet Session: Lipid Lowering via Novel Pathways Title: ARO-APOC3, an Investigational RNAi Therapeutic, Silences APOC3 and Reduces Atherosclerosis-Associated Lipoproteins in Patients With Mixed Dyslipidemia: MUIR Study Results Date/Time: November 13, 2023, 1:30 p.m. EST Presenter: Christie M Ballantyne Session: Emerging Approaches to Lipid Lowering Title: ARO-ANG3, an Investigational RNAi Therapeutic, Silences the Expression of ANGPTL3 and Decreases Atherogenic Lipoproteins in Patients With Mixed Dyslipidemia: ARCHES-2 Study Results Date/Time: November 13, 2023, 1:30 p.m. EST Presenter: Robert S Rosenson Session: Emerging Approaches to Lipid Lowering The analyst and investor event will feature presentations from Arrowhead management and three experts in the treatment and management of lipid and lipoprotein disorders: Daniel Gaudet, MD, PhD, Professor of Medicine at Université de Montréal, who will discuss plozasiran in the context of the current treatment landscape for severe hypertriglyceridemia Børge Nordestgaard, MD, Professor & Chief Physician, Copenhagen University Hospital, University of Copenhagen, Denmark, who will discuss remnant cholesterol and its role in cardiovascular disease Steven Nissen, MD, Chief Academic Officer for the Heart and Vascular Institute at the Cleveland Clinic, who will discuss the potential of a cardiovascular outcomes study of plozasiran Expert Bios Daniel Gaudet, MD, PhD, is Professor of Medicine at Université de Montréal (UdeM) and leads the UdeM Community Genetic Medicine Center and its Clinical Lipidology and Rare Lipid Disorders Unit. He is currently president and scientific director of ECOGENE-21, a non-for profit organization devoted to access to innovation in precision medicine. His main clinical and academic activities aim at investigating rare or severe dyslipidemias and translating new knowledge issued from extreme phenotypes to more common forms of diseases. Over the years, he has coordinated more than 200 clinical studies involving the development of screening tools, technologies or emerging therapies for severe dyslipidemias or related disorders, in collaboration with biotechs, pharmas, or academic partners. He authored more than 320 scientific publications in peer-reviewed journals, including several tens in very highly rated Journals (NEJM, Nature Medicine, Eur Heart J, Lancet, Nature Genetics) as well as >500 scientific communications or book chapters. Børge G. Nordestgaard, MD, DMSc, is Professor & Chief Physician, Copenhagen University Hospital, University of Copenhagen, Denmark, and President-Elect European Atherosclerosis Society. Prof Nordestgaard studied and worked in Copenhagen, New York, and London. He has for more than 30 years continued his interest in the pathogenesis, diagnosis and treatment of familial hypercholesterolemia, hyperlipidemia, lipoprotein(a), atherosclerosis, diabetes and cardiovascular disease, and has written extensively on these conditions. He is chairing the Copenhagen General Population Study and is a steering committee member of the Copenhagen City Heart Study and five phase 3 cardiovascular intervention trials. Prof. Nordestgaard has supervised 74 Ph.D. students and 34 postdoctoral fellows, and has published 920 original articles and 140 reviews, book chapters, consensus statements, & editorials. His H-index is 152 in Web of Science and he is listed among the top 0.1% researchers worldwide with the most highly cited papers. Original articles include publications in New England Journal of Medicine, Lancet, Journal of the American Medical Association, Nature, Science, Nature Genetics, British Medical Journal, Lancet Diabetes Endocrinology, Circulation, European Heart Journal, Journal of the American College of Cardiology and JAMA cardiology. Steven E. Nissen MD is Chief Academic Officer for the Heart and Vascular Institute at the Cleveland Clinic, the Lewis and Patricia Dickey Chair in Cardiovascular Medicine and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. From 2006 to 2019, he served as Chair of the Department of Cardiovascular Medicine at the Cleveland Clinic. In 2006-2007 he served as President of the American College of Cardiology (ACC), the professional society representing American cardiologists. His initial research focused on application of intravascular ultrasound (IVUS) imaging to the assessment of progression and regression of coronary atherosclerosis, conducting more than a dozen randomized controlled trials, most published in the NEJM or JAMA. More recently, he has served as Study Chairman for large global cardiovascular outcomes trials, most studying lipid modifying therapies. His contributions to scientific literature include more than 600 journal articles and 60 book chapters. He is co-author of a book for patients with heart disease, Heart411 released by Crown Books on January 31, 2012. Dr. Nissen works closely with pharmaceutical companies on the development of new therapies for cardiovascular disease, but maintains a longstanding policy of requiring companies to donate all related honoraria directly to charity so that he receives neither income, nor a tax deduction. He has also written extensively on the subject of drug safety. In 2001, he co-authored the first manuscript (JAMA) that raised concerns about the cardiovascular safety of rofecoxib (Vioxx™), which was withdrawn from the market 3 years later. In 2007, he authored a NEJM manuscript that demonstrated that the widely used diabetes drug rosiglitazone (Avandia™) raised the risk of myocardial infarction, eventually leading in 2010 to withdrawal of the drug in Europe and severe restrictions in the US. Dr. Nissen served as a member of the CardioRenal Advisory Panel of Food and Drug Administration (FDA) for 5 years, and Chairman the final year of his membership. He continues to serve as Advisor to several FDA committees as a “Special Government Employee”. In July 2008, while serving as guest member of the Endocrine and Metabolism Advisory Panel, he recommended a new approach for approval of diabetes drugs, which was ultimately adopted by the Agency in December 2008. Dr. Nissen is also known for his role in public policy discussions. He has testified in both the Senate (Health Education and Labor Committee) and House of Representatives (Energy and Commerce Committee) on Food and Drug Administration (FDA) policy. He was actively involved in discussions with Congress on the FDA Amendments Act of 2007 that added additional regulatory authority for the Agency. In 2007, Time Magazine selected Dr. Nissen as one of the world’s 100 most influential people. Beginning in 2015, he was named by Thompson-Reuters as one of the world’s most highly cited physician-scientists. A copy of the presentation materials and a webcast link for the analyst and investor event will be available on the Events and Presentations page under the Investors section of the Arrowhead website. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit , or follow us on Twitter @ArrowheadPharma. To be added to the Company's email list and receive news directly, please visit . Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc. View source version on businesswire.com: Contacts Arrowhead Pharmaceuticals, Inc. Vince Anzalone, CFA 626-304-3400 ir@arrowheadpharma.com Investors: LifeSci Advisors, LLC Brian Ritchie 212-915-2578 britchie@lifesciadvisors.com Media: LifeSci Communications, LLC Jason Braco, Ph.D. 646-751-4361 jbraco@lifescicomms.com Source: Arrowhead Pharmaceuticals, Inc. View this news release online at: