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News Archive

  • 02.21.2020  |  Evaluating for-profit public benefit corporations as an additional structure for antibiotic development and commercialization

    SCIENCE DIRECT | Antibiotics are a key infrastructure underpinning modern medicine, but evolution will continue to undermine their effectiveness, requiring continuous investment to sustain antibiotic effectiveness. The antibiotic R&D ecosystem is in peril, moving towards collapse. Key stakeholders have identified pull incentives such as Market Entry Rewards or subscription models as the key long-term solution. If substantial pull incentives become possible, there is every reason to expect that for-profit companies will return to the antibiotic field. However, the political and financial will to develop such incentives may be difficult to muster in the timeframes needed to prevent further diminishment of antibiotic R&D, especially if large drug companies are seen as substantial beneficiaries of these taxpayer-funded pull incentives. Bridging solutions are required in the interim. This analysis, authored by Kevin Outterson and John Rex, explores potential solutions led by private actors, including (1) traditional for-profit companies; (2) non-profit enterprises; and (3) public benefit corporations with lower profit expectations, akin to a public utility. All face similar commercial struggles, but nonprofits and public benefit corporations can accept lower profit expectations.

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  • 02.21.2020  |  Sepsis is more common, costly and deadly than previously thought

    HHS | A new study by researchers from the US Department of Health and Human Services.has found that sepsis is more common and costly than previously understood. Sepsis is a life-threatening condition caused by the body’s extreme response to an infection. The study shows that U.S. hospitals saw a 40 percent increase in the rate of Medicare beneficiaries hospitalized with sepsis over the past seven years, and in just 2018 had an estimated cost to Medicare of more than $41.5 billion. “Sepsis is a lethal and costly health threat affecting Americans’ lives and our economy, yet many Americans may have never heard of it,” said HHS Assistant Secretary for Preparedness and Response Dr. Robert Kadlec. “Any infection can lead to sepsis, including infections caused by influenza or emerging diseases like coronaviruses, which makes sepsis a significant concern in public health emergencies.”

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  • 02.14.2020  |  MCR-1 colistin resistance gene identified in Wyoming hospital patient

    CDC and WDH | A urinary tract infection (UTI) caused by multidrug-resistant bacteria carrying the MCR-1 colistin resistance gene was identified in a Wyoming hospital patient in early 2019, researchers from the Centers for Disease Control and Prevention (CDC) and the Wyoming Department of Health (WDH) reported in Morbidity and Mortality Weekly Report (MMWR). The patient had a history of recurrent UTIs. Admission urine culture and antimicrobial susceptibility testing identified the infecting pathogen as carbapenem-resistant Klebsiella pneumoniae with extended-spectrum beta-lactamase production. Further testing identified resistance to 16 antibiotics, as well as colistin, and identified a plasmid-mediated MCR-1 gene. It was not determined where the patient might have acquired the organism. The first US patient carrying MCR-1 was identified in Pennsylvania in July 2016, and since then MCR-1-carrying isolates have been identified in 20 other US states. Colistin is considered a last-resort antibiotic.

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  • 02.08.2020  |  Drugs From Bugs: Why Gates, Zuck And Benioff Think The Next Blockbusters Will Come From Inside Your Gut

    FORBES | A growing body of scientific research over the last 15 years has highlighted the crucial role the microbiome plays in human health. That new understanding could lead to breakthrough treatments for a huge range of illnesses, from digestive ailments and food allergies to cancer, serious infections and even autism. More than 50,000 scientific papers in the last five years have explored the microbiome’s effects. Various kinds of gut bacteria appear to stimulate or suppress immune responses in the body, while others seem to fight off disease-causing microbes. A groundswell of cutting-edge research has the potential to deliver a burst of new therapies that will vastly reduce human suffering—and generate huge paydays for the field’s pioneers. This article take at why some people are excited about the possibilities.

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  • 01.25.2020  |  The antimicrobial crisis: enough advocacy, more action

    THE LANCET | On the 30th anniversary of the World Economic Forum, The Lancet editorial board calls on governments and agencies to act to address the global threat of drug resistant bacteria.

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  • 01.23.2020  |  WHO Warns That Pipeline for New Antibiotics Is Running Dry

    NEW YORK TIMES | The World Health Organization has issued a fresh warning about the global threat of drug resistant infections. In two new reports — one that analyzed products being tested on patients and another that looked at therapies in the early stages of development — the WHO cited grim economic realities that have been strangling the few remaining companies working on the development of antimicrobial therapies.

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  • 01.17.2020  |  AMR Industry Alliance 2020 Progress Report: Successes and Setbacks in Fighting Superbugs

    AMR | The AMR Industry Alliance report provides a snapshot of the life science industry’s collective efforts in delivering on  commitments to tackle the rise of antimicrobial resistance (AMR). Results from the Alliance’s survey of biotech, diagnostics, generic and large research-based biopharmaceutical companies are mixed. Positive results include sustained investment in early R&D and diagnostics for AMR-related products (including antibiotics, antifungals, vaccines) and strides in responsible manufacturing of antibiotics. Worryingly, low levels of investment for later and more costly stages of R&D for AMR-related products may mean that promising early-stage compounds will never reach patients unless governments put in place new mechanisms and incentives for antibiotic development.  

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  • 01.16.2020  |  Reframing the antimicrobial resistance crisis

    THE HILL | Antimicrobials are special among classes of pharmaceuticals for several reasons, including their use in the treatment and prevention of infections, and also as a vital component of the medical countermeasures to be used during a biological attack. In this opinion piece, authors Dr. Amesh A. Adalja and Greg Salmieri argue that the antimicrobial market is in crisis and governments need to radically change the philosophical and moral way they view the development and delivery of new products to patients. The treatment and control of infectious diseases is historically one of the most civilizing and life-enhancing activities undertaken by humans. It deserves to be recognized and monetarily valued as such.

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  • 01.14.2020  |  The Broken Business of Antibiotics – a WSJ podcast on economic problems faced by antibiotics companies

    WALL ST JOURNAL and GIMLET MEDIA | WSJ’s Denise Roland explains the complex challenges facing antibiotics companies attempting to bring urgently needed new antibiotics onto the market.  17 minutes with ads. The world desperately needs new antibiotics to tackle the rising threat of drug-resistant superbugs, but there is little reward for doing so.

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  • 01.12.2020  |  Estimating the Size of the U.S. Market for New Antibiotics with Activity against Carbapenem-Resistant Enterobacteriaceae

    AMERICAN SOCIETY FOR MICROBIOLOGY | New antibiotics with activity against carbapenem-resistant Enterobacteriaceae (CRE) improve outcomes of CRE-infected patients. However, companies developing these drugs have faced financial difficulties. Sales of ceftazidime-avibactam, meropenem-vaborbactam, and plazomicin in the United States totaled $101 million from February 2018 to January 2019. The authors estimate that the current annual U.S. market for new anti-CRE antibiotics is an estimated $289 million. Without new antibiotic development models and/or reimbursement reform, the majority of anti-CRE drugs will be commercially inviable.

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  • 01.08.2020  |  ContraFect stock price doubles after Pfizer buys $3 million stake in company

    BARRON’S | Like all publicly traded antibacterial product developers, ContraFect had a rough year in 2019. The biotech firm (ticker: CFRX), which is focused on discovering and developing so-called direct lytic agents to treat life-threatening infectious diseases, including staphylococcus that is resistant to antibiotics, saw its stock price fall to 27 cents in August from $1.53 at the end of 2018. ContraFect, which has two projects funded by CARB-X, got a boost in December when Pfizer took a $3-million stake in the company. Its stock price has now bucked the trend among antibacterial product developers and is rallying.

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  • 01.07.2020  |  Antibiotics need a special place in the US drug pricing debate

    STAT NEWS | In this commentary, Pew Charitable Trust’s Allan Coukell warns that the rise of antibiotic resistance is inevitable as pathogens evolve to resist every existing antibiotic, and that if we allow the pipeline to dwindle, the price won’t be just in dollars, it will also be in lives lost. He urges the US congress to move swiftly to enact a package of economic incentives ‘to reinvigorate the stagnant pipeline of antibiotics. He also urges the US government to move forward with the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019, which could help ease the pressures working against new antibiotics in the US healthcare system. No single policy change will stem the exodus of investment from research on new antibiotics. But incentives such as these, combined with existing federal and public-private programs to defray research and development costs, are essential to turning the tide.

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  • 01.05.2020  |  Antibiotic Marketing and Pipeline Shortages in the Era of Stewardship: An Industry Perspective

    CONTAGIONLIVE | An industry overview of the economic and market challenges that antibiotics developers face, and the growing unmet medical need from drug-resistant bacterial infections.

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  • 01.05.2020  |  How to Combat Antibiotic Resistance: 5 Priorities for 2020

    PEW CHARITABLE TRUSTS | PEW’s antibiotic-resistance team examines the latest CDC findings on drug-resistant infections in the US and proposes 5 ways to combat resistance in 2020. The CDC report underscores the urgency of the threat, and need to maintain the fight against superbugs

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