{"id":993750,"date":"2026-08-11T16:22:17","date_gmt":"2026-08-11T20:22:17","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/"},"modified":"2026-08-11T16:22:17","modified_gmt":"2026-08-11T20:22:17","slug":"innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/","title":{"rendered":"Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwblockalignl { margin-left: 0px; margin-right: auto }\n.bwcellpmargin { margin-bottom: 0px; margin-top: 0px }\n.bwlistcircle { list-style-type: circle }\n.bwlistdisc { list-style-type: disc }\n.bwpadl0 { padding-left: 0px }\n.bwtablemarginb { margin-bottom: 10px }\n.bwuline { text-decoration: underline }\n.bwvertalignt { vertical-align: top }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO<\/b><sup>\u00ae<\/sup><b>, ZEVTERA<\/b><sup>\u00ae<\/sup><b> and NUZOLVENCE<sup>\u00ae<\/sup> Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award<\/b><\/p>\n<p>WALTHAM, Mass.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nInnoviva Specialty Therapeutics (IST), a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced today that three of the company\u2019s infectious disease therapies, XACDURO<sup>\u00ae<\/sup> (sulbactam\/durlobactam for injection), ZEVTERA<sup>\u00ae<\/sup> (ceftobiprole medocaril sodium for injection), and NUZOLVENCE<sup>\u00ae<\/sup> (zoliflodacin) are finalists for the 2026 Prix Galien USA Award in the <i>Best Pharmaceutical Product<\/i> category. This marks the third consecutive year an Innoviva Specialty Therapeutics product has been recognized by the renowned Galien Foundation.<\/p>\n<p>\n\u201cThis is the broadest slate of IST products to be designated as Prix Galien finalists, which is a testament to the clinical significance of the IST portfolio,\u201d said Pavel Raifeld, Chief Executive Officer of Innoviva, Inc. \u201cEach of these therapies addresses a distinct front in the fight against drug-resistant infections, and this nomination is further validation of our efforts to deliver life-saving medicines to patients.\u201d<\/p>\n<p>\nThe <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.galienfoundation.org%2Fprix-galien-usa&amp;esheet=54587368&amp;newsitemid=20260811564375&amp;lan=en-US&amp;anchor=Prix+Galien+award&amp;index=1&amp;md5=f302d22715935330088d10f0aad73451\">Prix Galien award<\/a> is widely regarded as the industry\u2019s equivalent of the Nobel Prize, recognizing groundbreaking advancements in the biopharmaceutical and medical technology industries that demonstrate the potential to significantly improve human health. The 2026 Award winners will be announced during a ceremony on October 29, 2026, in New York City.<\/p>\n<p>\n\u201cAs the public health crisis of antimicrobial resistance (AMR) further progresses, innovative therapeutics will continue to play an outsized role,\u201d said David Altarac, MD, Chief Medical Officer at Innoviva Specialty Therapeutics. \u201cTo that end, considering that AMR is estimated to be associated with significant morbidity and millions of deaths worldwide each year, we\u2019re privileged to be recognized for making notable strides in providing treatment for such difficult-to-treat infections.\u201d<\/p>\n<p>\nXACDURO, approved by the FDA in May 2023, remains the only antibiotic specifically approved for hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible isolates of <i>Acinetobacter baumannii-calcoaceticus<\/i> complex, a pathogen the World Health Organization classifies as a critical-priority drug-resistant threat.<\/p>\n<p>\nZEVTERA became in April 2024 the first cephalosporin approved by the FDA in nearly two decades for adults with <i>Staphylococcus aureus<\/i> bloodstream infections (bacteremia), including methicillin-resistant strains (MRSA), and is also indicated for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in adult and pediatric patients.<\/p>\n<p>\nNUZOLVENCE, approved by the FDA in December 2025, is a first-in-class, single-dose oral therapy for drug-resistant urogenital gonorrhea, developed through IST\u2019s collaboration with the Global Antibiotic Research and Development Partnership (GARDP), a not-for-profit organization.<\/p>\n<p><b>About The Prix Galien USA Award<\/b><\/p>\n<p>\nThe Prix Galien was created in France in 1970 in honor of Galen, the father of medical science and modern pharmacology. The Galien Foundation oversees and directs activities in the U.S. for the Prix Galien Awards, which includes the biennial Prix Galien International Awards. To qualify for a Prix Galien USA Award, each candidate must have been an FDA-approved product for marketing within the last five years and demonstrate tremendous potential to improve human health. The nominating committee does not consider sales data when selecting award nominees; they consider science and health impact.<\/p>\n<p><b>About ZEVTERA<sup>\u00ae<\/sup> (ceftobiprole medocaril sodium for injection)<\/b><\/p>\n<p>\nCeftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced-generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as <i>Staphylococcus aureus<\/i>,<i \/>including methicillin-resistant strains (MRSA), and Gram-negative bacteria. Outside the U.S., the brand is currently approved and marketed in several European countries and beyond as ZEVTERA<sup>\u00ae<\/sup> and Mabelio<sup>\u00ae<\/sup> for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries.<\/p>\n<p><b>INDICATIONS &amp; USAGE<\/b><\/p>\n<p><b>Indications<\/b><\/p>\n<p>\nZEVTERA<sup>\u00ae<\/sup> (ceftobiprole medocaril sodium for injection), for intravenous use, is indicated for the treatment of:<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nAdult patients with <i>Staphylococcus aureus<\/i> bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.<\/p>\n<\/li>\n<li>\nAdult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: <i>Staphylococcus aureus <\/i>(methicillin-susceptible and methicillin-resistant isolates), <i>Streptococcus pyogenes, <\/i>and <i>Klebsiella pneumoniae<\/i>.<\/p>\n<\/li>\n<li>\nAdult and pediatric patients (3 months to less than 18 years) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: <i>Staphylococcus aureus <\/i>(methicillin-susceptible isolates), <i>Streptococcus pneumoniae, Haemophilus influenzae<\/i>, <i>Haemophilus parainfluenzae<\/i>, <i>Escherichia coli<\/i>, and <i>Klebsiella pneumoniae<\/i>.<\/p>\n<\/li>\n<\/ul>\n<p><b>Usage<\/b><\/p>\n<p>\nTo reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.<\/p>\n<p><b>IMPORTANT SAFETY INFORMATION<\/b><\/p>\n<p><b>Contraindications<\/b>:<\/p>\n<p>\nZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class.<\/p>\n<p><b>Warnings and Precautions:<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIncreased mortality with unapproved use in ventilator-associated bacterial pneumonia (VABP) Patients: <b>The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved.<\/b><\/li>\n<li>\nSerious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZEVTERA is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been established. Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment.<\/p>\n<\/li>\n<li>\nSeizures and other adverse central nervous system (CNS) reactions have been reported during treatment with ZEVTERA and other cephalosporins. If CNS adverse reactions, including seizures, occur, evaluate patients to determine whether ZEVTERA should be discontinued.<\/p>\n<\/li>\n<li><i>Clostridioides difficile<\/i>-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, the risk\/benefit of continuing treatment with ZEVTERA should be assessed.\n<\/li>\n<\/ul>\n<p><b>Adverse Reactions:<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nSAB (adult patients): The most common adverse reactions occurring in \u2265 2% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, pyrexia, abdominal pain, fungal infection, headache, and dyspnea.<\/p>\n<\/li>\n<li>\nABSSSI (adult patients): The most common adverse reactions occurring in \u2265 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia.<\/p>\n<\/li>\n<li>\nCABP (adult and pediatric patients 3 months to less than 18 years of age):<\/p>\n<ul class=\"bwlistcircle\">\n<li>\nAdult Patients: The most common adverse reactions occurring in \u2265 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness.<\/p>\n<\/li>\n<li>\nPediatric Patients: The most common adverse reactions occurring in \u2265 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><b>About XACDURO<sup>\u00ae<\/sup><\/b><\/p>\n<p>\nXACDURO<b><sup>\u00ae<\/sup><\/b> (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP\/VABP) caused by susceptible isolates of <i>Acinetobacter baumannii-calcoaceticus<\/i> complex (<i>Acinetobacter<\/i>). XACDURO is not indicated for the treatment of HABP\/VABP caused by pathogens other than susceptible isolates of <i>Acinetobacter<\/i>.<\/p>\n<p><b>Current US FDA approved XACDURO<sup>\u00ae<\/sup> INDICATION &amp; USAGE<\/b><\/p>\n<p><b>Indication<\/b><\/p>\n<p>\nXACDURO<sup>\u00ae<\/sup> (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP\/VABP) caused by susceptible isolates of <i>Acinetobacter baumannii-calcoaceticus <\/i>complex.<\/p>\n<p><b>Limitations of Use<\/b><\/p>\n<p>\nXACDURO is not indicated for the treatment of HABP\/VABP caused by pathogens other than susceptible isolates of <i>Acinetobacter baumannii-calcoaceticus <\/i>complex.<\/p>\n<p><b>Usage<\/b><\/p>\n<p>\nTo reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.<\/p>\n<p><b>IMPORTANT SAFETY INFORMATION<\/b><\/p>\n<p><b>Contraindications<\/b>: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs.<\/p>\n<p><b>Warnings and Precautions:<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nHypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO.<\/p>\n<\/li>\n<li><i>Clostridioides difficile-<\/i>associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. If CDAD is suspected or confirmed, the risk\/benefit of continuing treatment with XACDURO should be assessed.\n<\/li>\n<li>\nPrescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.<\/p>\n<\/li>\n<\/ul>\n<p><b>Adverse Reactions: <\/b>The most common adverse reactions reported in &gt;10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%).<\/p>\n<p>\nTo report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.fda.gov%2Fmedwatch&amp;esheet=54587368&amp;newsitemid=20260811564375&amp;lan=en-US&amp;anchor=www.fda.gov%2Fmedwatch&amp;index=2&amp;md5=eee5ae664131c7274b50287b8d1ae6ea\">www.fda.gov\/medwatch<\/a>.<\/p>\n<p><b>Before administering, please see the <span class=\"bwuline\">Full Prescribing Information for XACDURO<\/span>.<\/b><\/p>\n<p><b>About NUZOLVENCE\u00ae (zoliflodacin) for oral suspension<\/b><\/p>\n<p>\nNUZOLVENCE is a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies. NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. The NUZOLVENCE mechanism of action is distinct from that of currently approved antibiotics and has demonstrated activity against drug-resistant <i>Neisseria gonorrhoeae<\/i>.<\/p>\n<p><b>Important Safety Information (ISI)<\/b><\/p>\n<p><b>Indication and Usage<\/b><\/p>\n<p><b>Indication<\/b><\/p>\n<p>\nNUZOLVENCE\u00ae is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg.<\/p>\n<p>\nUsage to Reduce Development of Drug-Resistant Bacteria: To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.<\/p>\n<p><b>Contraindications<\/b><\/p>\n<p>\nKnown history of hypersensitivity to NUZOLVENCE.<\/p>\n<p>\nConcomitant use with moderate or strong CYP3A4 inducers because this is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the NUZOLVENCE efficacy.<\/p>\n<p><b>Warnings and Precautions<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li><b>Embryo-Fetal Toxicity: Potential Risk for Pregnant Females<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nBased on data from animal studies, NUZOLVENCE may cause fetal harm when administered to a pregnant female at clinically relevant doses. Avoid use during pregnancy. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Obtain a pregnancy test prior to initiation in persons of reproductive potential.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential:<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nBased on data from an animal toxicity study, the risk of early pregnancy loss may be increased in female partners of males treated with NUZOLVENCE. Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after NUZOLVENCE administration.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Testicular Toxicity and Risks to Male Fertility:<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nBased on findings from animal studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. An assessment of spermatogenesis has not been conducted in humans. Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Hypersensitivity Reactions:<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nHypersensitivity reactions, including rash and pruritus, have been reported in patients receiving NUZOLVENCE. Before therapy with NUZOLVENCE is instituted, carefully inquire about previous hypersensitivity reactions to NUZOLVENCE. If an allergic reaction to NUZOLVENCE occurs, discontinue NUZOLVENCE and institute appropriate supportive measures.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Clostridioides difficile Infection (CDI):<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nCDI has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Development of Drug-Resistant Bacteria:<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPrescribing NUZOLVENCE in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><b>Adverse Reactions<\/b><\/p>\n<p>\nThe most common adverse reactions (\u22652%) are headache, dizziness, nausea, and diarrhea. Laboratory abnormalities (neutropenia, leukopenia) were also observed.<\/p>\n<p><b>Drug Interactions<\/b><\/p>\n<p>\nConcomitant use with moderate or strong CYP3A4 inducers is contraindicated.<\/p>\n<p><b>Use in Specific Populations<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li><b>Pregnancy:<\/b> Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female. A postmarketing descriptive pregnancy safety study is available for NUZOLVENCE. If exposure occurs during pregnancy, pregnant females or their healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861.\n<\/li>\n<li><b>Lactation:<\/b> There are no data on the presence of zoliflodacin in either human or animal milk, effects on the breastfed infant, or effects on milk production. If NUZOLVENCE is present in breast milk, intestinal flora alteration in the breastfed infant could occur.\n<\/li>\n<li><b>Females and Males of Reproductive Potential:<\/b> Based on animal studies, NUZOLVENCE may cause fetal malformations when administered to a pregnant female at clinically relevant doses. Additionally, based on data from an animal study, the risk of early pregnancy loss may be increased in partners of males treated with NUZOLVENCE.\n<\/li>\n<li><b>Pregnancy Testing:<\/b> Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with NUZOLVENCE.\n<\/li>\n<li><b>Contraception:<\/b> Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after their single-dose treatment of NUZOLVENCE.\n<\/li>\n<li><b>Infertility:<\/b> Based on data from repeat-dose animal toxicity and fertility studies, NUZOLVENCE may cause testicular toxicity and impair male fertility.\n<\/li>\n<li><b>Pediatric Use:<\/b> The safety and effectiveness of NUZOLVENCE in pediatric patients younger than 12 years of age or weighing less than 35 kg have not been established.\n<\/li>\n<li><b>Geriatric Use:<\/b> Clinical studies of NUZOLVENCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.\n<\/li>\n<\/ul>\n<p><b>Reporting Adverse Events<\/b><\/p>\n<p><b>You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:<\/b><\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nInnoviva Specialty Therapeutics\u2122<\/p>\n<p class=\"bwcellpmargin\">\n1-800-651-3861<\/p>\n<p class=\"bwcellpmargin\"><a rel=\"nofollow\" href=\"mailto:medinfo@istx.com\">medinfo@istx.com<\/a>\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/p>\n<\/td>\n<td class=\"bwvertalignt\" rowspan=\"1\" colspan=\"1\">\u00a0<\/td>\n<td class=\"bwvertalignt bwpadl0\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nU.S. Food and Drug Administration<\/p>\n<p class=\"bwcellpmargin\">\n1-800-FDA-1088<\/p>\n<p class=\"bwcellpmargin\"><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.fda.gov%2Fmedwatch&amp;esheet=54587368&amp;newsitemid=20260811564375&amp;lan=en-US&amp;anchor=www.fda.gov%2Fmedwatch&amp;index=3&amp;md5=2bbc6b075e4bbe19b788d88d28b17b62\">www.fda.gov\/medwatch<\/a><\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p><b>About Innoviva Specialty Therapeutics<\/b><\/p>\n<p>\nInnoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics\u2019 products, through its affiliates, include GIAPREZA<sup>\u00ae<\/sup> (angiotensin II), XERAVA<sup>\u00ae<\/sup> (eravacycline), XACDURO<sup>\u00ae<\/sup> (sulbactam for injection; durlobactam for injection), and NUZOLVENCE<sup>\u00ae<\/sup> (zoliflodacin). Innoviva Specialty Therapeutics 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 Specialty Therapeutics, please visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.innovivaspecialtytherapeutics.com&amp;esheet=54587368&amp;newsitemid=20260811564375&amp;lan=en-US&amp;anchor=www.innovivaspecialtytherapeutics.com&amp;index=4&amp;md5=f99e4e0f4fae1aa4af405d16773bde09\">www.innovivaspecialtytherapeutics.com<\/a>.<\/p>\n<p><b>Forward Looking Statements<\/b><\/p>\n<p>\nThis press release contains certain \u201cforward-looking\u201d statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words \u201canticipate\u201d, \u201cexpect\u201d, \u201cgoal\u201d, \u201cintend\u201d, \u201cobjective\u201d, \u201copportunity\u201d, \u201cplan\u201d, \u201cpotential\u201d, \u201ctarget\u201d and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR<sup>\u00ae<\/sup>\/BREO<sup>\u00ae<\/sup> ELLIPTA<sup>\u00ae<\/sup>, ANORO<sup>\u00ae<\/sup> ELLIPTA<sup>\u00ae<\/sup>, GIAPREZA<sup>\u00ae<\/sup>, XERAVA<sup>\u00ae<\/sup>, XACDURO<sup>\u00ae<\/sup>, ZEVTERA<sup>\u00ae<\/sup> and NUZOLVENCE<sup>\u00ae<\/sup> in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva\u2019s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the development of the LYNX<sup>\u00ae<\/sup> platform; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company\u2019s growth strategy. Other risks affecting Innoviva are described under the headings \u201cRisk Factors\u201d and \u201cManagement\u2019s Discussion and Analysis of Financial Condition and Results of Operations\u201d contained in Innoviva\u2019s Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (\u201cSEC\u201d) and available on the SEC\u2019s website at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sec.gov&amp;esheet=54587368&amp;newsitemid=20260811564375&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=5&amp;md5=860b578755d8760bfc2ac84cb28e8101\">www.sec.gov<\/a>. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward looking statements on account of new information, future events or otherwise, except as required by law.<\/p>\n<p>\nANORO<sup>\u00ae<\/sup>, RELVAR<sup>\u00ae<\/sup> and BREO<sup>\u00ae<\/sup> are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica International AG, Allschwil.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260811564375r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20260811564375\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260811564375\/en\/<\/a><\/span><\/p>\n<p>\nInvestor and Media Contact<br \/>\n<br \/>Irwin Tendler<br \/>\n<br \/>Head of Investor Relations<br \/>\n<br \/>Executive Director, Corporate Development<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:investors.relations@inva.com\">investors.relations@inva.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> Massachusetts United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Infectious Diseases Biotechnology Pharmaceutical Health<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260811564375\/en\/2873056\/3\/innoviva_specialty_therapeutics_TM_primary_navy.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award WALTHAM, Mass.&#8211;(BUSINESS WIRE)&#8211; Innoviva Specialty Therapeutics (IST), a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced today that three of the company\u2019s infectious disease therapies, XACDURO\u00ae (sulbactam\/durlobactam for injection), ZEVTERA\u00ae (ceftobiprole medocaril sodium for injection), and NUZOLVENCE\u00ae (zoliflodacin) are finalists for the 2026 Prix Galien USA Award in the Best Pharmaceutical Product category. This marks the third consecutive year an Innoviva Specialty Therapeutics product has been recognized by the renowned Galien Foundation. \u201cThis is the broadest slate of IST products to be designated as Prix Galien finalists, which is a testament to the clinical significance of the IST portfolio,\u201d said &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-993750","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award WALTHAM, Mass.&#8211;(BUSINESS WIRE)&#8211; Innoviva Specialty Therapeutics (IST), a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced today that three of the company\u2019s infectious disease therapies, XACDURO\u00ae (sulbactam\/durlobactam for injection), ZEVTERA\u00ae (ceftobiprole medocaril sodium for injection), and NUZOLVENCE\u00ae (zoliflodacin) are finalists for the 2026 Prix Galien USA Award in the Best Pharmaceutical Product category. This marks the third consecutive year an Innoviva Specialty Therapeutics product has been recognized by the renowned Galien Foundation. \u201cThis is the broadest slate of IST products to be designated as Prix Galien finalists, which is a testament to the clinical significance of the IST portfolio,\u201d said &hellip; Continue reading &quot;Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-08-11T20:22:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260811564375r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"15 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award\",\"datePublished\":\"2026-08-11T20:22:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\\\/\"},\"wordCount\":2992,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20260811564375r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\\\/\",\"name\":\"Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award - 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(NASDAQ: INVA), announced today that three of the company\u2019s infectious disease therapies, XACDURO\u00ae (sulbactam\/durlobactam for injection), ZEVTERA\u00ae (ceftobiprole medocaril sodium for injection), and NUZOLVENCE\u00ae (zoliflodacin) are finalists for the 2026 Prix Galien USA Award in the Best Pharmaceutical Product category. This marks the third consecutive year an Innoviva Specialty Therapeutics product has been recognized by the renowned Galien Foundation. \u201cThis is the broadest slate of IST products to be designated as Prix Galien finalists, which is a testament to the clinical significance of the IST portfolio,\u201d said &hellip; Continue reading \"Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/","og_site_name":"Market Newsdesk","article_published_time":"2026-08-11T20:22:17+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260811564375r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"15 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award","datePublished":"2026-08-11T20:22:17+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/"},"wordCount":2992,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260811564375r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/innoviva-specialty-therapeutics-antimicrobial-therapies-xacduro-zevtera-and-nuzolvence-designated-finalists-for-the-2026-prix-galien-usa-best-pharmaceutical-product-award\/","name":"Innoviva Specialty Therapeutics\u2019 Antimicrobial Therapies, XACDURO\u00ae, ZEVTERA\u00ae and NUZOLVENCE\u00ae Designated Finalists for the 2026 Prix Galien USA Best Pharmaceutical Product Award - 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