Latest news with #GARDP
Business Upturn
12-06-2025
- Business
- Business Upturn
FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025
Geneva, Switzerland & Waltham, Mass., United States: FDA is expected to notify Innoviva Specialty Therapeutics regarding its decision to conduct an Advisory Committee Meeting in the Day 74 letter If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act (PDUFA). It is expected the FDA will notify Innoviva Specialty Therapeutics regarding the FDA's decision to conduct an Advisory Committee Meeting in the Day 74 letter. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades. The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity. Entasis Therapeutics, Inc., the legal NDA holder and affiliate of Innoviva Specialty Therapeutics, Inc., retains the commercial rights for zoliflodacin in the major markets in North America, Europe, and Asia-Pacific. GARDP retains the right to register and commercialize the product in more than three-quarters of the world's countries, including all low-income countries, most middle-income countries, and several high-income countries. GARDP is committed to working with its partners and local health authorities in markets where zoliflodacin receives regulatory approval to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use. About Uncomplicated Gonorrhea With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the second most common bacterial sexually transmitted infection (STI), affecting both men and women, which, if left untreated, can result in serious and permanent health consequences. With the rise and spread of drug-resistant infections, the World Health Organization (WHO) has identified antimicrobial resistance (AMR) as one of the ten most critical global threats to public health. The bacterium Neisseria gonorrhoeae, which causes gonorrhea, has progressively developed resistance to most classes of antibiotics used to treat these infections, including ceftriaxone, a widely used intramuscular injection that was first made available in 1984. About Zoliflodacin Zoliflodacin is an investigational first-in-class antibacterial that is administered in a single oral dose for the treatment of uncomplicated gonorrhea. The oral route of administration simplifies treatment by providing a convenient option for patients unable to receive an intramuscular injection. Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. In in vitro studies, zoliflodacin demonstrated activity against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. In a pivotal Phase 3 clinical trial, zoliflodacin demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection with a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of 500mg ceftriaxone followed by 1g of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial. About GARDP The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ('IST'), and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered with Glaxo Group Limited ('GSK'). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva's other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva also markets ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva, go to . For information about Innoviva Specialty Therapeutics, go to . ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Yahoo
12-06-2025
- Business
- Yahoo
FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025
FDA is expected to notify Innoviva Specialty Therapeutics regarding its decision to conduct an Advisory Committee Meeting in the Day 74 letter If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades WALTHAM, Mass. & GENEVA, June 12, 2025--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act (PDUFA). It is expected the FDA will notify Innoviva Specialty Therapeutics regarding the FDA's decision to conduct an Advisory Committee Meeting in the Day 74 letter. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades. The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity. Entasis Therapeutics, Inc., the legal NDA holder and affiliate of Innoviva Specialty Therapeutics, Inc., retains the commercial rights for zoliflodacin in the major markets in North America, Europe, and Asia-Pacific. GARDP retains the right to register and commercialize the product in more than three-quarters of the world's countries, including all low-income countries, most middle-income countries, and several high-income countries. GARDP is committed to working with its partners and local health authorities in markets where zoliflodacin receives regulatory approval to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use. About Uncomplicated Gonorrhea With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the second most common bacterial sexually transmitted infection (STI), affecting both men and women, which, if left untreated, can result in serious and permanent health consequences. With the rise and spread of drug-resistant infections, the World Health Organization (WHO) has identified antimicrobial resistance (AMR) as one of the ten most critical global threats to public health. The bacterium Neisseria gonorrhoeae, which causes gonorrhea, has progressively developed resistance to most classes of antibiotics used to treat these infections, including ceftriaxone, a widely used intramuscular injection that was first made available in 1984. About Zoliflodacin Zoliflodacin is an investigational first-in-class antibacterial that is administered in a single oral dose for the treatment of uncomplicated gonorrhea. The oral route of administration simplifies treatment by providing a convenient option for patients unable to receive an intramuscular injection. Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. In in vitro studies, zoliflodacin demonstrated activity against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. In a pivotal Phase 3 clinical trial, zoliflodacin demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection with a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of 500mg ceftriaxone followed by 1g of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial. About GARDP The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ("IST"), and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered with Glaxo Group Limited ("GSK"). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva's other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva also markets ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva, go to For information about Innoviva Specialty Therapeutics, go to ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil. View source version on Contacts Media Innoviva Specialty TherapeuticsDavid +1.908.421.5971 GARDP Duncan Graham-Rowedgrahamrowe@ +44 7966 413623 Investors Argot Partnersinnoviva@ +1.212.600.1902 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
12-06-2025
- Business
- Business Wire
FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025
WALTHAM, Mass. & GENEVA--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act (PDUFA). It is expected the FDA will notify Innoviva Specialty Therapeutics regarding the FDA's decision to conduct an Advisory Committee Meeting in the Day 74 letter. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades. The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity. Entasis Therapeutics, Inc., the legal NDA holder and affiliate of Innoviva Specialty Therapeutics, Inc., retains the commercial rights for zoliflodacin in the major markets in North America, Europe, and Asia-Pacific. GARDP retains the right to register and commercialize the product in more than three-quarters of the world's countries, including all low-income countries, most middle-income countries, and several high-income countries. GARDP is committed to working with its partners and local health authorities in markets where zoliflodacin receives regulatory approval to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use. About Uncomplicated Gonorrhea With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the second most common bacterial sexually transmitted infection (STI), affecting both men and women, which, if left untreated, can result in serious and permanent health consequences. With the rise and spread of drug-resistant infections, the World Health Organization (WHO) has identified antimicrobial resistance (AMR) as one of the ten most critical global threats to public health. The bacterium Neisseria gonorrhoeae, which causes gonorrhea, has progressively developed resistance to most classes of antibiotics used to treat these infections, including ceftriaxone, a widely used intramuscular injection that was first made available in 1984. About Zoliflodacin Zoliflodacin is an investigational first-in-class antibacterial that is administered in a single oral dose for the treatment of uncomplicated gonorrhea. The oral route of administration simplifies treatment by providing a convenient option for patients unable to receive an intramuscular injection. Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. In in vitro studies, zoliflodacin demonstrated activity against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. In a pivotal Phase 3 clinical trial, zoliflodacin demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection with a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of 500mg ceftriaxone followed by 1g of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial. About GARDP The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ('IST'), and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered with Glaxo Group Limited ('GSK'). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ®. Innoviva's other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva also markets ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva, go to For information about Innoviva Specialty Therapeutics, go to ANORO ®, RELVAR ® and BREO ® are trademarks of the GSK group of companies. ZEVTERA ® is a trademark of Basilea Pharmaceutica Ltd, Allschwil.
India Today
02-06-2025
- Health
- India Today
Superbugs are spreading as India faces gaps in drug supply, access to treatment
While antibiotics are being overused in some places, leading to the rise of deadly superbugs, in other parts of the world, people are dying because they can't access these life-saving drugs at all.A study, published in The Lancet Infectious Diseases, was led by the Global Antibiotic Research and Development Partnership (GARDP), a non-profit that works to improve access to antibiotics, looked at nearly 1.5 million cases of infections caused by carbapenem-resistant Gram-negative (CRGN) bacteria across eight low- and middle-income countries, including India, Brazil, and South bacteria are dangerous because they are resistant to "last-line" antibiotics. These are medicines that are used when all others fail. Yet, the study found that only 6.9% of patients in these countries received the right CARRIES THE HEAVIEST BURDENIndia had the largest number of cases among all countries studied. It also procured 80% of the full antibiotic courses examined. But despite this, only 7.8% of people with CRGN infections received the proper points to a gap between drug supply and actual access to treatment.A full course of antibiotics means the complete number of doses a patient must take to fully fight off an infection. The study found that only 6.9% of patients in 8 countries, including India, received the right treatment. () advertisementMissing out on even a part of this treatment makes it less effective and more dangerous in the long drug-resistant bacteria are commonly found in water, food, the environment, and even in our own bodies. They can cause serious infections like urinary tract infections (UTIs), pneumonia, and food babies, elderly people, and hospital patients are especially at risk, particularly those in intensive care units (ICUs).CRGN infections are tough to treat because the bacteria no longer responds to some of the most powerful antibiotics we have. This is where the crisis deepens: in places where these infections are rising, the drugs needed to treat them are either missing or too ACCESS CRISISFor years, the focus has been on the overuse of to Dr. Jennifer Cohn, GARDP's Global Access Director, the reality is that many people in low- and middle-income countries with deadly drug-resistant infections are "dying because they can't get the antibiotics they need," she was quoted by study looked at eight different intravenous antibiotics that are active against these resistant bacteria. Bacterial infections are tough to treat because the bacteriano longer responds to some of the most powerful antibiotics we have. () Tigecycline, one of the drugs in the study, was the most widely used. But even then, only about 1 lakh full courses were available across all eight countries, far fewer than the 1.5 million people who needed ARE PATIENTS MISSING OUT?As per the study, there are many reasons why patients don't receive the right could be because they aren't reaching the right hospital or clinic, not getting an accurate diagnosis, not able to access the correct antibiotics or there's a high cost of newer of these antibiotics are simply too expensive for the average patient in countries like India. Without better policies, price regulation, and access programs, millions will continue to suffer or die POLICIESThe experts said that two things are needed urgently: stronger rules to prevent misuse of antibiotics and better systems to make them affordable and available to those who truly need access alone isn't enough. The world is also facing a shrinking pipeline of new fewer companies investing in antibiotic research, the options for treating future infections are has one of the highest burdens of antimicrobial resistance (AMR) in the world. But researchers say the country also holds great potential to lead the global fight against drug-resistant infections. India has one of the highest burdens of antimicrobial resistance (AMR) in the world. () India's strong pharmaceutical sector is already leading efforts in antibiotic innovation. From developing new drugs to improving diagnostics, the country has a head suggest that India can further improve by gathering local data. This would help identify what's needed, where the gaps are, and how to fix them. Some states are already trying new instance, Kerala is using a "hub-and-spoke" system where smaller clinics get support from larger hospitals in treating complex solution is pooled procurement, where hospitals or states buy drugs together in bulk, reducing costs. This has worked for cancer medicines and could be tried for antibiotics the end, the battle against superbugs is not just about using antibiotics wisely, it's also about making sure they're within everyone's Reel
Saudi Gazette
02-06-2025
- Health
- Saudi Gazette
Deadly superbugs thrive as access to antibiotics falters in India
DELHI — It's a grim paradox, doctors say. On the one hand, antibiotics are being overused until they no longer work, driving resistance and fuelling the rise of deadly superbugs. On the other hand, people are dying because they can't access these life-saving drugs. A new study by the non-profit Global Antibiotic Research and Development Partnership (GARDP) looked at access to antibiotics for nearly 1.5 million cases of carbapenem-resistant Gram-negative (CRGN) infections across eight major low- and middle-income countries, including India, Brazil and South Africa. CRGN bacteria are superbugs resistant to last-line antibiotics — yet only 6.9% of patients received appropriate treatment in the countries studied. India bore the lion's share of CRGN infections and treatment efforts, procuring 80% of the full courses of studied antibiotics but managing to treat only 7.8% of its estimated cases, the study in The Lancet Infectious Diseases journal reports. (A full drug course of antibiotics refers to the complete set of doses that a patient needs to take over a specific period to fully treat an infection.) Common in water, food, the environment and the human gut, Gram-negative bacteria cause infections such as urinary tract infections (UTIs), pneumonia and food poisoning. They can pose a serious threat to newborns and the elderly alike. Especially vulnerable are hospital patients with weakened immunity, often spreading rapidly in ICUs and proving difficult - and sometimes impossible - to treat. Treating carbapenem-resistant Gram-negative bacterial infections is doubly difficult because those bacteria are resistant to some of the most powerful antibiotics."These infections are a daily reality across all age groups," says Dr Abdul Gaffar, infectious disease consultant at Apollo Hospital in India's Chennai city. "We often see patients for whom no antibiotic works — and they die."The irony is cruel. While the world tries to curb antibiotic overuse, a parallel tragedy plays out quietly in poorer nations: people dying from treatable infections because the right drugs are out of reach."For years, the dominant narrative has been that antibiotics are being overused, but the stark reality is that many people with highly drug-resistant infections in low- and middle-income countries are not getting access to the antibiotics they need," says Dr Jennifer Cohn, GARDP's Global Access Director and senior author of the study examined eight intravenous drugs active against carbapenem-resistant bacteria - ranging from older antibiotics including Colistin to newer ones such as Ceftazidime-avibactam. Of the few available drugs, Tigecycline was the most widely blame the treatment gap on weak health systems and limited access to effective example, only 103,647 full treatment courses were procured of Tigecycline across eight countries — far short of the 1.5 million patients who needed them, the study found. This highlighted a major shortfall in the global response to drug-resistant prevents patients with drug-resistant infections in India from getting the right antibiotics?Physicians point to multiple barriers - reaching the right health facility, getting accurate diagnostic tests, and accessing effective drugs. Cost remains a major hurdle, with many of these antibiotics priced far beyond the reach of poorer patients."Those who can afford these antibiotics often overuse them; those who can't, don't get them at all," says Dr Gaffar. "We need a system that ensures access for the poor and prevents misuse by the well-to-do."To improve access, these drugs must be made more affordable. To prevent misuse, stronger regulation is key."Ideally, every antibiotic prescription in hospitals should require a second sign-off - by an infection specialist or microbiologist," says Dr Gaffar. "Some hospitals do this, but most don't. With the right oversight, regulators can ensure this becomes standard practice."To fix the access problem and curb misuse, both smarter policies and stronger safeguards are essential, say researchers. But access alone won't solve the crisis - the pipeline of new antibiotics is drying up. The decline in antibiotic R&D - and the limited availability of existing drugs - is a global bears one of the world's heaviest burdens of antimicrobial resistance (AMR), but it may also hold the key to combating it - both at home and globally, researchers say."India is also one of the largest markets for new antibiotics and can successfully advocate for the development and access of new antibiotics," says Dr Cohn. With a strong pharmaceutical base, the country is emerging as a hub for AMR innovation, from promising new antibiotics to advanced Cohn says India can strengthen its antibiotic response by generating local data to better estimate needs and pinpoint gaps in the care would allow for more targeted interventions to improve access to the right models are already emerging - Kerala state, for instance, is using a "hub-and-spoke approach" to support lower-level facilities in managing serious infections. Coordinated or pooled procurement across hospitals or states could also reduce the cost of newer antibiotics, as seen with cancer drug programs, researchers access to the right antibiotics, modern medicine begins to unravel - doctors risk losing the ability to safely perform surgery, treat complications in cancer patients, or manage everyday infections."As an infectious disease doctor, I see appropriate use as one part - but only one part - of access," says Dr Gaffar. "When we get new antibiotics, it's important to save them on one hand - and save them for right patients."Clearly, the challenge is not just to use antibiotics wisely, but to ensure they reach those who need them most. — BBC
