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10.23.2020 | Improving data sharing to increase the efficiency of antibiotic R&D
NATURE REVIEWS DRUG DISCOVERY | Much of modern medicine would not be possible without effective antibiotics, but the rise of antibiotic resistance is inevitable. We need to spend more money on antibiotic R&D to address this challenge, but we can also spend smarter, by encouraging data sharing, especially from failed projects. This will help every antibiotic research team learn from the work of others, instead of reinventing the wheel. More widespread data sharing, such as the recent joint data contribution from Merck and Kyorin to the Pew Charitable Trusts’ SPARK platform, has a key role.The opinion piece was co-authored by Kevin Outterson (CARB-X), Zak Zimmerman (Forge) and Kevin Krause (formerly Achaogen).
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10.16.2020 | Stuck in the 1950s: why UTI diagnosis badly needs an update
THE PHARMACEUTICAL JOURNAL | Urinary tract infections are the second most common reason for prescribing an antibiotic and, with antimicrobial stewardship a growing priority around the world, the stakes for accurate diagnosis are being raised ever higher. Product developers, like CARB-X-funded Module Innovations, are racing to find better more efficient tools to diagnose drug-resistant UTIs more quickly, within hours rather than days, to facilitate appropriate treatment more quickly and potentially save lives.
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10.15.2020 | Feds release new national antibiotic resistance plan
CIDRAP | The updated National Action Plan for Combating Antibiotic-Resistant Bacteria, 2020-2025 is a roadmap to guide the nation’s response to the rise and spread of drug-resistant bacteria. The five goals of the plan remain the same as those in the first plan, which came out in March 2015. But the objectives for meeting those goals have been updated. Among the new objectives are a 20% reduction in the number of healthcare-associated antibiotic-resistant infections and 10% reduction in community-acquired antibiotic-resistant infections by 2025, support for 10 new resistance-related diagnostics projects by 2021, and support for the clinical development of 10 novel therapeutics for bacterial infections by 2022.
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09.10.2020 | Peptilogics Receives FDA Orphan Drug Designation for Novel Peptide Therapy for the Treatment of Prosthetic Joint Infections
PR NEWSWIRE | The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for PLG0206, a first-in-class, broad-spectrum antibiotic peptide developed by Peptilogics. PLG0206 is in development for the treatment of prosthetic joint infections (PJI), a rare life-threatening condition that may result from arthroplasty or joint replacement procedures. PLG0206 is funded by CARB-X.
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09.02.2020 | A novel pre-clinical antibacterial pipeline database
PLOS ONE | Investment and research are needed to ensure that a robust clinical pipeline is built to treat the WHO priority pathogens list of antibiotic-resistant bacteria. The WHO has created a database projects underway which captures 252 unique antibacterial agents in preclinical development being developed by 145 individual institutions, of which the majority are smaller biotech companies and academic institutions. There is a higher degree of innovation in the preclinical pipeline with a significant number of non-traditional approaches being pursued. This article, co-authored by CARB-X Alliance Director Richard Alm, takes a closer look at the pipeline to understand its strengths and gaps.
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08.19.2020 | The antibiotic paradox: why companies can’t afford to create life-saving drugs
NATURE | Antibiotics present an enduring economic puzzle. These drugs changed the world. Yet despite their unique power, the free market doesn’t value them. In just the past two years, four companies that survived the decade-long process of development and testing to get a new antibiotic approved – Achaogen, Aradigm, Melinta Therapeutics and Tetraphase – declared bankruptcy or put themselves up for sale. The reasons are complex. Science writer Maryn McKenna looks at one company, Paratek Pharmaceuticals, and how it has managed to deliver a new antibiotic to the market and survive. COVID-19 has highlighted more than ever the critical need for new antibiotics, and for the need to be better prepared to address public health emergencies. But have we learned that lesson?
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08.12.2020 | Pharmaceutical firms commit US$1 billion to antibiotic development
NATURE Reviews Drug Discovery | Twenty-four large and medium-sized pharmaceutical firms are backing a US$1 billion fund to steward antibiotics through phase II and III trials. Can they also break an antibiotic reimbursement impasse? COVID-19 has shown lawmakers just how horribly costly it is to be unprepared. There is no excuse to caught flat-footed in the face of drug resistant bacteria. Kevin Outterson says if it works, the sector can be turned around. But if it doesn’t work, there is a risk private investment goes away for a generation.
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08.12.2020 | We need new antimicrobials to prevent the next infectious disease crisis
STAT | Imagine if scientists had seen Covid-19 coming years in advance yet did little to prepare. Unthinkable, right? Yet that’s exactly what’s happening with another infectious disease crisis — the one caused by antibiotic-resistant bacteria and fungi. Superbugs already kill more than 700,000 people each year. And the World Health Organization warns that by 2050 the annual death toll could reach 10 million if we don’t use the time to get prepared. The antibiotics and other antimicrobial drugs needed to prevent such a calamity don’t yet exist. The problem isn’t a lack of willing scientists, but rather a broken marketplace that has made it virtually impossible for researchers to attract adequate funding. In this opinion piece, Kevin Outterson and John Rex argue that lawmakers must act to address the economic obstacles to innovation. If they don’t, we could face another public health crisis as formidable as COVID19.
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08.09.2020 | It is time to fix the antibiotic market
WELLCOME TRUST | We need to keep developing new antibiotics to make sure we can keep protecting ourselves from ever-evolving bacteria. But the antibiotics market is faltering, as economic disincentives make it impossible to get the innovations we need. Governments, pharmaceutical companies and philanthropy must act now to reform the market and safeguard a sustainable supply of these lifesaving drugs.
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08.05.2020 | Racing the clock to stop drug-resistant superbugs
BOSTON GLOBE MAGAZINE | Antibiotics are the foundation of modern medicine, protecting us from infections stemming from injuries and childhood maladies, and making surgery, transplants, and chemotherapy safer. They are also now the last defense against the worst complications of COVID-19. Yet we have let their development languish. We are not developing the new antibiotics we need to win the race against drug-resistant superbugs. Drug resistant bacteria kills 700,000 people around the world each year, including 35,000 Americans. This in-depth article by Maryn McKenna looks at the economic challenges plaguing antibiotics and at what CARB-X is doing to address the crisis.
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08.04.2020 | Could Drug-Resistant Bacteria Cause The Next Pandemic?
FORBES | Aided by modern humans’ mobility and by climate change, bacterial pathogens endanger everyone’s health. They are legion, varied, and constantly mutating. Pathogenic bacteria cause epidemics and pandemics. Bacteria mutate to become resistant to antibiotics. Antibiotic-resistant (AR) bacteria spread in communities and healthcare settings. Discovery and development of new antibiotics are insufficiently incentivized, despite the good work of organizations like CARB-X. In this commentary, biochemist Louis Metzger IV argues that governments, industry, and academia must collaborate to bring new classes of antibiotics to the clinic.
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07.31.2020 | How a crumbling antibiotics infrastructure could yield ‘catastrophe’
PBS NewsHour | Part 2 of 2. The antibiotics industry has suffered an alarming collapse that has become even more troubling as secondary bacterial infections threaten patients with COVID-19. Why has production of these vital medicines stagnated, and what can be done to address the problem? PBS NewsHour Economics correspondent Paul Solman reports on why lifesaving drugs don’t necessarily translate to lucrative businesses. 7:58 minutes.
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07.30.2020 | As a virus ravages the world, antibiotic makers are in disarray
PBS NewsHour | Part 1 of 2. COVID-19 can be accompanied by secondary bacterial infections with deadly consequences. But the antibiotics R&D industry has been upended — and the pandemic is only making things worse. Paul Solman reports. 7:15 minutes.
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07.14.2020 | Pattern receives additional funding to speed development of its rapid diagnostic
Pattern has announced $9 million in additional funding to accelerate the development and clinical validation of its Digital CultureTM rapid bacterial identification and susceptibility testing (ID/AST) technology, a diagnostic project that is funded by CARB-X. The new funding is led by Illumina Ventures and OmniMed Capital.
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07.13.2020 | New $1bn action fund is a much-needed shot in the arm for our broken antibiotics market
TELEGRAPH | After years of pulling away from investment in antibiotic R&D, large pharmaceutical companies that launched the $1bn AMR Action Fund are showing they finally understand what is at stake. This initial investment while significant can sustain only a fraction of the pipeline, realistically advancing only two or three new drugs to market. Jeremy Knox, policy lead for Wellcome Trust’s drug-resistant infections programme, argues in this opinion piece that long-term sustainability depends on governments stepping in to fairly incentivise the antibiotic innovation we all need. It is time for politicians to recognise that like a COVID vaccine, antibiotics are a medical innovation we can’t afford to live without.
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07.10.2020 | New pharma-led fund aims to boost antibiotic development
CIDRAP | A coalition of more than 20 leading pharmaceutical companies today announced the launch of a new fund to provide financial incentives to boost antibiotic development efforts and help the smaller companies engaged in much of the research on new, innovative drugs to tackle antimicrobial resistance (AMR). The AMR Action Fund will invest nearly $1 billion in smaller biotech companies with the aim of bringing two to four new antibiotics to market by 2030. Kevin Outterson, executive director of CARB-X, said the fund is “life-saving” for many of these companies, which are often looking to partner with larger companies with more money and technical knowledge once they get their products through phase 1 clinical trials. But it will not solve the underlying problems that plague the antibacterial market. Governments need to step up to create a stable marketplace for these antibiotics once they are approved.
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07.09.2020 | A Plan to Avert a ‘Superbug’ Pandemic
WALL STREET JOURNAL | A group of 20+ pharmaceutical companies have created a $1-billion fund to address the growing antibiotic-resistance crisis by supporting the development of up to four new new antibiotics by 2030. David Ricks, Chairman and CEO of Eli Lilly, and Kasim Kutay, CEO of Novo Holdings, underscore the important work that CARB-X and other organizations have done to revitalize the early-stage pipeline. But these efforts face a lack of investors willing to shoulder the high costs and risks of later stages of development. The AMR Action Fund will shoulder some risk and expense, at least for a few years. But it is not a permanent solution. It is time for policy makers and government to take the bold actions needed to prevent another pandemic.
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06.24.2020 | CARB-X-funded Vaxcyte (formerly Sutrovax) has announced the closing of its Initial Public Offering (IPO)
Vaxcyte Inc (Nasdaq: PCVVX), a next-generation vaccine company in Foster City, CA, USA, has announced the closing of its initial public offering. The aggregate gross proceeds from the offering were $287.5 million before deducting commissions and expenses. The shares began trading on Nasdaq on June 12, 2020. One of Vaxcyte’s projects, a vaccine to prevent Group A Strep infections, is funded by CARB-X.
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06.24.2020 | Saving Antibiotics: It will take more than science to keep these life-saving drugs from becoming treatments of the past
MEDIUM – As part of a series on solvable problems for a forward-looking world, journalist Sara Reardon examines antibiotics and the challenges we face to develop new antibiotics that are needed today and in the future to address the alarming rise of drug-resistant bacteria. She tells the story of the market failure, and examines efforts by governments, CARB-X, GARDP and other organizations to spur innovation and build a sustainable economic model that will deliver the innovative products we need to address the resistance crisis and save lives. But much more coordination and vision is needed from government to deliver the innovative products we need. Quoting John Rex, she concludes “A silver lining to the COVID-19 crisis is it’s teaching everyone how expensive it is when you don’t have the right fire extinguisher.”
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06.14.2020 | HelixBind awarded $3 million grant from NIH to expand its diagnostic platform
HelixBind, which is developing an innovative diagnostic platform funded by CARB-X to test for drug-resistant bacterial infections, has been awarded a new $3-million grant from the US National Institutes of Health (NIH). The NIH grant is to support the expansion of capabilities of RaPID, its direct-from-blood platform for the identification and characterization of bloodstream infections, to test for fungal infections. The new test would utilize the same analyzer and cassette as the RaPID diagnostic for drug resistant bacteria, but would use a separate panel to diagnose fungal infections, particularly Candida auris, an emerging fungus resistant to existing antifungals. HelixBind’s diagnostic platform aims to reduce time-to-diagnosis of bloodstream infections from days to hours.
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06.12.2020 | Innovation in Antimicrobial Resistance: The CARB-X Perspective
ACS INFECTIOUS DISEASES | Antimicrobial resistance has emerged as a major threat to public health and CARB-X was created in 2016 to fund and support the early development of innovative antibiotics, vaccines, rapid diagnostics, and other products. This in-depth article by Karen Gallant, Deputy Executive Director of CARB-X, and Richard Alm, CARB-X Alliance Director, examines progress CARB-X has made, applications for funding rounds in 2016-19, pathogens targeted in the CARB-X portfolio, the network of AMR funding organizations around the world, and some of the economic challenges related to delivering new urgently needed products to patients.
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06.03.2020 | Coronavirus Pandemic Highlights Need to Spur Antibiotic Innovation
PEW TRUSTS | The ongoing COVID-19 pandemic is drawing attention to the need for effective antibiotics and continued efforts to thwart antibiotic resistance, now and in the future, writes Kathy Talkington, Project Director of the Antibiotic Resistance Project, at Pew Charitable Trusts. Many COVID-19 patients will likely die from secondary bacterial infections rather than the virus. Widespread antibiotic use amplifies the opportunity for resistant pathogens to emerge and spread. The antibiotic pipeline is already thin. The COVID-19 crisis highlights the pressing need to accelerate development of new antibiotics. We cannot afford to be caught flat-footed when a new superbug crisis emerges. If a company had made a COVID-19 vaccine in 2018, it would have had zero value, Kevin Outterson, CARB-X Executive Director, says. But today, it would be worth trillions. Just like the COVID-19 pandemic, antibiotic resistance is a global threat that must be fought with preparation and early action.
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05.05.2020 | Antibiotic pipeline in peril from coronavirus and incentives system
AXIOS | The COVID-19 pandemic is exposing the dire state of the antibacterial pipeline, and the urgent need for investment to be prepared for more antibiotic resistant infections to emerge. The US Government Accountability Office last week publicly released a report with eight recommendations for the federal government on how to better determine and address the problem. The conclusion? Having a full and effective arsenal of antibiotics, antimicrobials and antifungals is an important component of being prepared for the next pandemic.
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05.05.2020 | Coronavirus lessons for the fight against ‘superbugs’
FINANCIAL TIMES | We have known for years that a deadly problem is worsening. Antimicrobial resistance (AMR) — when infection-causing microbes become immune to the medicines used to combat them — is growing. Pipelines for drugs that could defeat such “superbugs” are precariously thin. Each year, 700,000 people die around the world. As a global society, we know AMR is spreading. We know about it, and we know what needs to be done: create a viable environment that fosters research and development and ensures that the growth of resistance is sustainably managed and controlled. If we had had the foresight to develop a drug to prevent or treat coronavirus a few years ago, we would not be in the midst of a global pandemic today. Like coronavirus, AMR is a global threat, with commensurate benefits to be gained from early action.
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04.29.2020 | Is AMR the next, but hidden, crisis?
EUROPEAN BIOTECHNOLOGY | With the coronavirus pandemic mounting, experts are already warning of antimicrobial resistance as being the next, hidden crisis. The AMR community still urgently waits for substantial pull incentives. While the US DISARM act was pulled at the last minute from the country’s corona stimulus package, the UK’s NHS has started stakeholder engagement for its flat-rate model. Meanwhile, CARB-X-funded company Forge Therapeutics has closed a €170m deal with Roche and Paratek received a long-term BARDA contract. Typically, antibiotic work has not been seen as a high priority for big pharma in the past years, but with COVID-19, this may change.
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04.09.2020 | Have We Made Progress in the 10 X ’20 Initiative?
ContagionLive | The Infectious Diseases Society of America (IDSA) has worked hard to raise awareness about the antimicrobial resistance crisis and the need for progress in developing medicines to treat resistant infections. In 2010, IDSA issued a call for 10 new antibacterial agents by the year 2020. That 10×’20 goal has been achieved with 14 new antibiotics becoming available. However, these medications are floundering in a failing market. The broken market needs to be fixed, now. In this analysis, Dr. Helen Boucher, director of the Tufts Center for Integrated Management of Antimicrobial Resistance, urges the US government to take action.
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03.25.2020 | Forge Enters into Collaboration with Roche to Develop Novel Antibiotic to Treat Lung Infections
Forge Therapeutics announced today that it has entered into a research collaboration and option agreement with Hoffmann-La Roche Ltd. to license FG-LpxC LUNG, a novel antibiotic for the treatment of serious lung infections attributed to antibiotic-resistant Gram-negative bacteria including Pseudomonas aeruginosa. The FG-LpxC LUNG program is being developed, with support from CARB-X, to treat hospital-based infections which commonly occur in people with weakened immune systems and chronic lung diseases. Forge is eligible to receive US$190.5M in total payments and potential sales-based payments and royalties upon commercialization of the program. This is the first CARB-X funded program to be the subject of such an agreement with a major pharmaceutical company.
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03.17.2020 | Coronavirus Surprised The World, But Doctors Have Been Sounding The Alarm On Another Global Health Threat For Years
WGBH | COVID19 surprised the world but scientists have been warning for years about another global health threat. WGBH’s Stephanie Leydon speaks to a patient, Dr. Helen Boucher at Tufts Medical Centre and CARB-X’s Kevin Outterson to examine the threat of drug-resistant bacterial infections and the challenges of developing innovative products to prevent, diagnose and treat them.
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02.24.2020 | New Genomic Tests Aim to Diagnose Deadly Infections Faster
NEW YORK TIMES | Rapid genomic tests are poised to change the way doctors diagnose and treat bacterial infections, but cost concerns may limit widespread use despite their usefulness. Developers of the some of the devices say that once the genetic sequence of a novel pathogen has been made publicly available, the information could be quickly uploaded and used to identify those infected. NYT Health and Science journalist Andrew Jacobs interviews experts at T2, Day Zero Diagnostics and other companies about the benefits of using these advanced technologies to diagnose serious infections, and the challenges that companies face in getting governments and hospitals to use better technology .
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02.05.2020 | The Fatally Slow Quest for Next-Gen Antibiotics
MEN’S HEALTH | Many bacteria have stopped responding to the drugs that used to kill them, and drugmakers have stopped responding to alarms about it. Can the system possibly be fixed before the bacteria win? Science writer Sarah Richards examines the high human toll superbugs are taking, the economics of antibiotics, and looks for answers from experts in the field, including BARDA Director Rick Bright.
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01.27.2020 | The Broken Model of Antimicrobial Resistance: Let’s Talk About Solutions
An expert panel moderated by CARB-X Executive Director Kevin Outterson discusses solutions to the antimicrobial resistance crisis at a session sponsored by Novo Nordisk Foundation during the World Economic Forum in Davos, January 21, 2020. Listen to an interview with Outterson and other experts.
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01.27.2020 | Tackling antimicrobial resistance on multiple fronts
PHARMA MARKET LIVE | Daniel Berman, Head of Global Health at Nesta Challenges, calls for a new international funding mechanism to be created, one that will be initiated and backed by multiple players, including decision-makers and influencers in pharma and healthcare who know the scale of the AMR challenges we face.
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01.21.2020 | Why developing new antibiotics is a matter of life and death
NOVO HOLDINGS | In this opinion piece timed to the World Economic Forum Davos 2020, Kasim Kutay, Chief Executive Director of Novo Holdings, says the drought of new treatments for drug-resistant infections will not end anytime soon, unless policy-makers fix the broken antibiotics market.
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01.17.2020 | Novel Drug Candidate Aims To Tackle Superbug Infections In Cystic Fibrosis Patients
FORBES | In a world where antibiotics are becoming increasingly unsuccessful at treating infections, those who suffer worst are often the sick and the young. Unfortunately, in the case of Cystic Fibrosis, patients often check off both these boxes. The French bio-pharmaceutical company Antabio is developing a way to help these vulnerable patients. This month, Antabio was granted $4.4 million by CARB-X in a second tranche of funding to continue to develop its Pseudomonas Elastase Inhibitor (PEi) program. This is in addition to $2.8 million awarded in 2017. The Antabio program is focused on a novel small molecule candidate that was found to be a potential adjunct treatment for Pseudomonas aeruginosa infections in Cystic Fibrosis patients. Antabio CEO Marc Lemonnier, said: “Its actually a groundbreaking approach, it’s never been done before. I think that’s what CARB-X has recognized and that’s why they are funding.”
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01.08.2020 | Antabio continues research for lung infection therapy with $4.4 million support from CARB-X
CYSTIC FIBROSIS NEWS TODAY | Biopharmaceutical company Antabio has been awarded $4.4 million by CARB-X in a second tranche of funding to continue its research for a therapy against Pseudomonas aeruginosa lung infections in people with cystic fibrosis (CF). The funding will be used to support Antabio’s Pseudomonas Elastase Inhibitor (PEi) program, which is seeking to develop a small molecule to stop the action of the LasB elastase protein. That protein, made by the bacteria Pseudomonas aeruginosa, causes damage and inflammation to lung tissue, and prevents the immune system from defending against the bacteria effectively.
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01.05.2020 | Antibiotic Makers Struggle, Hurting War on Superbugs
WALL STREET JOURNAL | The world desperately needs new antibiotics to tackle the rising threat of drug-resistant superbugs, but there is little reward for doing so. The companies that have stepped up to the challenge are going bust. Washington has taken notice of the problems, but near-term action remains unlikely. The Disarm Act, short for Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms and introduced in Congress in 2019, would have Medicare pay for certain antibiotics in full. Despite bipartisan support for the bill, progress could be hindered by impeachment proceedings and the coming election. Another idea is a “market entry reward,” a one-time sum paid to companies that launch a new antibiotic. But for now, these improvements are not materializing. “The longer we wait for a sustainable solution, the more companies will die, and the more the earlier pipeline will degrade,” said Kevin Outterson, Professor of Law specializing in the antibiotics market at Boston University. “That’s my real fear.”
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01.05.2020 | Crisis Looms in Antibiotics as Drug Makers Go Bankrupt
NEW YORK TIMES | At a time when germs are growing more resistant to common antibiotics, Big Pharma has fled the antibiotics field and now start-ups are going belly up, threatening to stifle the development of new drugs. Experts say the grim financial outlook for the few companies still committed to antibiotic research is driving away investors and threatening to strangle the development of new lifesaving drugs at a time when they are urgently needed. The industry faces another challenge: doctors have become reluctant to prescribe the newest medications, limiting the ability of companies to recoup their investment. And in their drive to save money, many hospital pharmacies will dispense cheaper generics even when a newer drug is far superior. “You’d never tell a cancer patient ‘Why don’t you try a 1950s drug first and if doesn’t work, we’ll move on to one from the 1980s,” said Kevin Outterson, the executive director of CARB-X, a government-funded nonprofit that provides grants to companies working on antimicrobial resistance. “We do this with antibiotics and it’s really having an adverse effect on patients and the marketplace.”
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