Avibactam Sodium/Aztreonam

A roundup of the most newsworthy healthcare press releases from PR Newswire, including business strategies shaping the future of healthcare and three major health news trends. NEW YORK, March 7, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, February 2025. Photos provided by CINDE, Sebela Pharmaceuticals Inc and WeWard. BD Announces Intent to Separate Biosciences and Diagnostic Solutions Business to Enhance Focus, Drive Growth and Unlock Value "Our BD 2025 strategy has transformed the company into a faster-growing, more profitable organization positioned at the forefront of long-term growth trends in health care," said Tom Polen, chairman, CEO and president of BD. FDA Approves MIUDELLA®, the First Hormone-Free Copper Intrauterine System (IUS) in the U.S. in Over 40 Years, from Sebela Women's Health Inc. "This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options," said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. Lilly launches additional Zepbound vial doses and offers new savings for self-pay patients Self-pay patients with obesity now have additional Zepbound vial options, including 2.5 mg, 5 mg, 7.5 mg and 10 mg doses. In addition to expanding the doses available, Lilly has reduced prices of the 2.5 mg and 5 mg vials to $349 per month and $499 per month, respectively. Costa Rica Continues to Strengthen Its Position as a Leading Hub for Life Sciences Companies Since 2017, Costa Rica's medical device exports have grown at an average annual rate of 18%, surpassing $8 billion in 2024. This rapid expansion has positioned the country as Latin America's second-largest exporter of medical devices and the fifth-largest supplier of these products to the United States. The Cigna Group Launches Actions to Drive Positive Change for Customers and Patients "The health care system in America needs to be better, and we have challenged ourselves to help lead and drive systemic change," said David M. Cordani, chairman and CEO of The Cigna Group. "We do a lot of good for many people, but we need to do better for everyone. We are committed to implementing tangible actions across our company to help drive better health outcomes and health care experiences." Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia Troriluzole has a well-established safety profile and if approved, would be the first and only FDA-approved treatment for Spinocerebellar Ataxia (SCA), a rare, genetic, life-threatening neurodegenerative disease. AbbVie and Xilio Therapeutics Announce Collaboration and Option Agreement to Develop Novel Tumor-Activated Immunotherapies The collaboration will combine AbbVie's oncology expertise and Xilio's proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers. Solventum Announces Sale of its Purification & Filtration Business to Thermo Fisher Scientific Inc. for $4.1B "We are confident that Thermo Fisher will provide the Purification & Filtration business – which offers filters and membranes for use in the manufacturing of biopharmaceutical and medical technologies, microelectronics and food, beverage products and drinking water – the strategic investment and resources needed for sustaining growth and delivering customer solutions," said Bryan Hanson, Solventum CEO. FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. Chan Zuckerberg Initiative Launches Billion Cells Project with 10x Genomics and Ultima Genomics to Advance AI in Biology "Biology not only needs more data – the field needs more data faster and in interoperable formats to support AI models that address specific problems, and this project represents a unique approach to scaling and standardizing scientific outputs for AI and more," said Jonah Cool, Cell Science Senior Science Program Officer at CZI. Medtronic earns U.S. FDA approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's DBS is similar to a cardiac pacemaker, but for the brain. It uses a surgically implanted neurostimulator via a minimally invasive procedure to transmit electrical signals to specific parts of the brain affected by debilitating neurological disorders. Illumina unveils first-of-its-kind spatial transcriptomics technology Illumina has announced a new spatial technology program that will empower researchers to map complex tissues and understand cellular behavior at an unprecedented scale. "With this innovation, we are setting a new bar that will drive the next wave of scientific discoveries and unlock a deeper understanding of biology," said Steve Barnard, PhD, chief technology officer of Illumina. U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options "As bacteria evolve, industry, government, and clinical experts must work together to ensure that the infectious disease community has the tools to advance public health," said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance." U.S. FDA Approves Expanded Label for Astellas' IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy Since receiving a permanent J-code in April 2024, IZERVAY has had month-over-month growth in the U.S. with more than 210,000 vials distributed through the end of December 2024. Texas Children's Hospital and UT MD Anderson Announce Joint Venture to End Childhood Cancer The partnership forms the nation's largest complement of pediatric subspecialty care and services to children diagnosed with all types of cancer within a single entity, with operations planned to launch in early 2026. For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics Among the health news that was distributed in February, the PR Newswire team was able to spot several larger stories that highlight the trends shaping the industry. American Heart Month: February featured extensive focus on cardiovascular health with diverse awareness initiatives across multiple sectors. Prevention took center stage as Venus Williams invested in the WeWard walking app, Planet Fitness promoted strength training accessibility, and Texas advocates rallied for cardiac emergency response plans in schools during Heart Month. Former Miss Ohio Lindsay Davis joined cardiologists to raise awareness for hypertrophic cardiomyopathy, while NFL Hall of Famer Jerome Bettis partnered with the CDC Foundation's Live to the Beat campaign to address hypertension's impact on Black adults. HIMSS25: The healthcare technology sector generated significant wire activity surrounding the 2025 HIMSS Global Health Conference in Las Vegas (March 3-6). AI innovation dominated announcements, with companies unveiling solutions ranging from Kontaktio's agentic AI for care orchestration to Amtelco's AI-powered virtual agent Ellie. Industry collaboration also emerged as a key theme, with major EHR providers MedAllies, Epic, Netsmart, and eClinicalWorks announcing a joint demo, while Microsoft partnered with Canary Speech to advance digital health transformation. Rare Disease Day: As Rare Disease Day approached on Feb. 28, PR Newswire distributed numerous announcements highlighting advocacy efforts and research breakthroughs. The National Organization for Rare Disorders (NORD) released a critical report on newborn screening programs and later partnered with Paramount Pictures to amplify awareness. The Rare Disease Diversity Coalition prepared to host its 2nd Annual RISE Awards, while NFL legends joined advocates from 49 states for the 14th annual Rare Disease Week on Capitol Hill. Additional mainstream support for the rare disease community came from the New York Stock Exchange with a special pre-market update commemorating Rare Disease Day. Looking ahead: This March, women's health themes will likely dominate coverage surrounding International Women's Day (March 8) and throughout Women's History Month. PR Newswire also anticipates significant activity around National Nutrition Month, with releases spotlighting dietary innovations and wellness campaigns. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. 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BridgeBio Pharma has received European approval for a drug that treats cardiomyopathy stemming from a rare metabolic condition, strengthening the biotech’s position to take market share from the blockbuster Pfizer drug that is currently the standard treatment. The European Commission granted marketing authorization to acoramidis, which BridgeBio developed as treatment for transthyretin amyloidosis (ATTR), a disease in which a genetic mutation leads to abnormal versions of the liver protein transthyretin (TTR). The misfolded proteins can cause nerve and heart problems. BridgeBio’s acoramidis, which will be commercialized in Europe as Beyonttra, is a small molecule designed to stabilize TTR to treat the cardiomyopathy caused by the disease. The biotech contends its drug is a better stabilizer than the drugs marketed by Pfizer. For 2024, Pfizer reported $3.3 billion in revenue from its Vyndaqel family of TTR stabilizers, a 36% increase compared to 2023. The FDA approved the BridgeBio TTR drug this past November and it is marketed in the U.S. under the brand name Attruby. In a prescriptions update included in its report of fourth quarter and full year 2024 financial results, BridgeBio said that as of Feb. 17, 1,028 unique patient prescriptions for the drug have been written by 516 unique prescribers since the U.S. approval. That’s an increase from what the company reported last month during the annual J.P. Morgan Healthcare Conference last month, which Leerink Partners said indicates a broadening prescriber base. presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical In Europe, the BridgeBio drug will be commercialized by Bayer per terms of an agreement signed last year. BridgeBio is in line to receive milestone payments and royalties from sales. The first payment is $75 million for the European approval. Here’s a recap of other recent regulatory developments: More Rare Disease Drug Approvals —The FDA approved Mirum Pharmaceuticals drug chenodiol, brand name Ctexli, for treating rare lipid storage disease cerebrotendinous xathomatosis (CTX). This genetic metabolic disorder results in deficient levels of an enzyme important for breaking down fats. Chenodiol is a naturally occurring human bile acid. Under the brand name Chenodal, chenodiol has been marketed for treating gallstones, but it has been used off label as a treatment for CTX. The new FDA approval makes Ctexli the first FDA-approved treatment for CTX. Mirum acquired the drug from Travere Therapeutics in 2023. Sponsored Post Tips for Greater Healthcare Practice Success in 2025 Join us on February 26 at 3 pm ET, and we’ll dive into the key areas where practices are losing time and money and provide solutions to overcome them. By Elation Health and MedCity News —The European Commission approved Livdelzi, a Gilead Sciences drug developed for the rare liver disease primary biliary cholangitis (PBC). The conditional marketing authorization covers use of the daily pill in combination with ursodeoxycholic acid, an older drug that is the standard PBC treatment. The European decision for Livdelzi follows FDA approval of the drug last August. Livdelzi comes from Gilead’s $4.3 billion acquisition of Cymabay Therapeutics last year. —The FDA approved SpringWorks Therapeutics drug Gomekli as a treatment for tumors caused by the rare genetic disorder neurofibromatosis type 1 (NF1). The approval covers treatment of these tumors in both adults and children. That’s an advantage over AstraZeneca’s Koselugo, which is only approved for treating pediatric NF1 patients. —CSL’s garadacimab received approvals in Europe and Japan for treating adults and adolescents age 12 and older who have hereditary angioedema (HAE). The rare disease leads to swelling attacks in tissue beneath the skin. This swelling can close off the airway, putting a patient at risk of death. CSL’s drug, brand name Andembry, is an antibody engineered to inhibit activated Factor XII, a protein that starts the cascade of events leading to unpredictable HAE swelling attacks. Andembry is still under regulatory review in the U.S., Canada, and Switzerland. —Evrysdi, a drug marketed by Roche for the rare disease spinal muscular atrophy, is now approved in a tablet formulation. The product, which was initially developed by PTC Therapeutics and later partnered with Roche, was first approved in 2020 as a liquid administered via an oral syringe or through a feeding tube. The liquid formulation must be refrigerated and kept away from light. The new Evrysdi tablet offers patients a simpler dosing option that can be stored at room temperature. Cancer Drug Approvals —Merck’s Welireg is now approved in Europe as a treatment for adults with von Hillel-Lindau (VHL) disease, a rare genetic disorder that causes benign tumors in the body that can become cancerous. The European Commission’s conditional approval covers patients whose VHL is unsuitable for surgery and requires therapy for renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors. The commission’s decision also covers the treatment of adults with advanced clear cell renal cell carcinoma that has progressed after two or more lines of therapy. Welireg is a once-daily pill designed to block HIF-2 alpha, inhibiting this protein’s ability to contribute to cancer progression. The FDA approved Welireg in 2021. —The FDA approved Romvimza, an Ono Pharmaceutical drug for tenosynovial giant cell tumor (TGCT). The drug, which came to Ono via the 2024 acquisition of its developer, Deciphera Pharmaceuticals, offers more convenient dosing and a lower risk of liver toxicity compared to Turalio, a Daiichi Sankyo drug that was the first approved systemic therapy for TGCT. —Datroway, a TROP-2-targeting antibody drug conjugate (ADC) from partners AstraZeneca and Daiichi Sankyo, landed FDA approval for treating advanced and unresectable breast cancer that’s classified as HR positive and HER2 negative. It will compete with Trodelvy, Gilead Sciences’ TROP-2-targeting ADC is already approved in the same indication. —Axsome Therapeutics’ Symbravo won FDA approval for acute treatment of migraine with or without aura in adults. The tablet pairs two compounds that target multiple pathways behind a migraine attack. Symbravo is made with proprietary Axsome technology that enables the drug to more quickly achieve maximum concentration in the blood and to maintain a long half-life. Symbravo’s label carries a black box warning for cardiovascular and gastrointestinal risks. The approval marks a comeback for the drug, which received an FDA complete response letter in 2022 due to manufacturing issues. —Foundation Medicine received FDA approval for FoundationOne CDx as a companion diagnostic for the brain cancer drug Ojemda. The test detects the BRAF V600 mutation addressed by the drug, developed by Day One Biotherapeutics. The FDA approved Ojemda last April as a treatment for advanced cases of pediatric low-grade glioma. —Adcetris, an antibody drug conjugate (ADC) developed by Pfizer subsidiary Seagen, added to its label the treatment of advanced cases of diffuse large B-cell lymphoma (DLBCL). The new approval covers use of the drug in combination with the cancer drugs Revlimid and Rituxan. The new FDA approval is based on Phase 3 results showing the Adcetris regimen led to a 37% reduction in risk of death compared to Revlimid, Rituxan, and a placebo. Adcetris was first approved in 2011 for Hodgkin lymphoma and systemic anaplastic large cell lymphoma. The drug now has eight FDA approvals in cancer. Pfizer has rights to the drug in the U.S. and Canada; Takeda Pharmaceutical has rights to the product in the rest of the world. —Blockbuster AstraZeneca cancer drug Calquence, first approved in 2017 for treating advanced mantle cell lymphoma after at least one prior line of therapy, is now approved as a first-line treatment for this rare and aggressive blood cancer. The drug, a BTK inhibitor, is the first in its class approved as a first-line MCL treatment. —Amgen cancer drug Lumakras expanded its FDA approval to metastatic colorectal cancer that is positive for the KRAS G12c mutation and is also unresponsive or resistant to chemotherapy. The regulatory nod in this indication covers use of the daily pill in combination with Vectibix, an Amgen antibody drug approved for colorectal cancer. Lumakras was initially approved in 2022 as a treatment for non-small cell lung cancer driven by the KRAS G12C mutation. Approvals in Immunology —Galderma drug Nemluvio received European Commission approval as a treatment for the inflammatory skin disorders atopic dermatitis and prurigo nodularis. The once-monthly injection is an antibody designed to block IL-31 signaling. The FDA approved Nemluvio for prurigo nodularis and atopic dermatitis last year. —Eli Lilly’s Omvoh, a biologic drug first approved in 2023 as a treatment for ulcerative colitis, added moderately to severely active Crohn’s disease to its label. The drug is an antibody that targets IL-23p19, a protein that contributes to gastrointestinal inflammation. Regulatory submissions in Crohn’s are currently under review in Europe and Japan. In ulcerative colitis, the drug is approved in 44 countries. —Palforzia, a peanut allergy immunotherapy marketed by Stallergenes Greer, expanded the product’s approved uses in Europe to include the treatment of children ages 1 through 3. The initial approval for Palforzia covered children age 4 through 17. The new approval in Europe comes about six months after the therapy secured a similar regulatory decision from the FDA. Privately held Stallergenes Greer added Palforzia to its allergy products portfolio via a 2023 deal with Nestlé. Approvals for Neuro, Pain Meds —Supernus Pharmaceuticals received FDA approval for Onapgo, a drug/device combination product that continuously infuses the drug apomorphine to treat the “off” episodes experienced by Parkinson’s disease patients. Onapgo joins a Supernus Parkinson’s drug lineup that includes Apokyn, an injection pen product that administers apomorphine, and Gocovri, a capsule approved to treat dyskinesia and off time in Parkinson’s patients. —Vertex Pharmaceuticals’ non-opioid drug Journavx won FDA approval as a first-in-class treatment for moderate-to-severe acute pain in adults. The twice-daily pill targets NaV1.8, a pathway in the peripheral nervous system. By stopping pain signals in the periphery before they reach the brain, drugs in this class are intended to avoid the addiction risks poised by opioids, which hit targets in the brain. —The FDA approved Johnson & Johnson’s Spravato as a monotherapy for adults with treatment-resistant depression. The nasal spray drug’s initial approval in 2019 covered its use in combination with an oral antidepressant for treatment-resistant depression in adults. Vaccine Approvals —Bavarian Nordic received FDA approval for its virus-like particle chikungunya vaccine, which will be marketed under the brand name Vimkunya. The FDA nod covers use of the vaccine in those age 12 and older. That’s a broader range than Valneva’s Ixchiq, which became the first FDA-approved chikungunya vaccine in 2023. Ixchiq is indicated for use in those age 18 and older. Bavarian Nordic’s new approval was accompanied by a tropical disease priority review voucher, which the company said it plans to sell. —A GSK vaccine covering five groups of bacteria that cause meningococcal disease is now FDA approved for use in those ages 10 through 25. The vaccine, brand name Penmenvy, combines components of two already available GSK meningococcal vaccines, Bexsero and Menveo. Penmenvy will now compete with Pfizer’s Penbraya, which also covers five bacterial groups. Both vaccines are administered as two intramuscular injections given six months apart. —A Covid-19 vaccine developed by partners Arcturus Therapeutics and CSL is now approved in Europe. The vaccine, brand name Kostaive, employs self-amplifying RNA. Unlike traditional mRNA vaccines, self-amplifying RNA vaccines instruct the body to make more mRNA and protein to boost the immune response. Kostaive was originally developed by Arcturus. In 2022, CSL paid $200 million up front to collaborate on the vaccine. Per deal terms, Arcturus is responsible for regulatory filings in the U.S. and Europe as well as R&D of next-generation vaccine candidates. CSL subsidiary Seqirus takes the lead on all other R&D in Covid-19, influenza, and other fields. More Regulatory Approvals —Izervay, a geographic atrophy drug marketed by Astellas Pharma, is now approved for longer dosing. The product’s initial 2023 approval permitted the once-monthly eye injection to be administered for up to 12 months. The new approval removes the 12 month restriction. However, the Astellas product did not receive the FDA O.K. for every-other-month administration. That additional flexibility would have put it on par with Apellis Pharmaceuticals’ geographic atrophy drug Syfovre, which is approved for monthly and every-other-month dosing. —Novo Nordisk drug Ozempic is now approved for treating chronic kidney disease in patients with type 2 diabetes. The blockbuster drug was initially approved for type 2 diabetes, which is a risk factor for chronic kidney disease. In the pivotal study supporting the latest regulatory nod, Ozempic led to a 24% reduction in kidney disease complications compared to a placebo. —AbbVie’s pairing of the antibiotics aztreonam and avibactam received FDA approval for the treatment of complicated intra-abdominal infections, giving clinicians another tool to address antimicrobial resistance. The therapy, which will be marketed under the brand name Emblaveo, is indicated for use in combination with Flagyl, a Pfizer antibiotic. Emblaveo was developed in partnership with Pfizer. AbbVie has commercialization rights to the drug in the U.S and Canada; Pfizer is responsible for the antibiotic’s commercialization in the rest of the world. Clinical Holds and Regulatory Setbacks —The FDA sent Harmony Biosciences a refuse to file letter for pitolistant, a drug the biotech is seeking to commercialize as a treatment for excessive daytime sleepiness in adults who have idiopathic hypersomnia. In a Phase 3 withdrawal study, the once-daily tablet did not achieve statistical significance compared to placebo. The biotech said a Phase 3 registrational study in idiopathic hypersomnia is on track to begin in the fourth quarter of this year. Pitolistant is already available as a treatment for excessive daytime sleepiness or cataplexy in adults with narcolepsy, marketed as Wakix in this indication. —Moderna’s Phase 3 test of its two-season norovirus vaccine candidate, mRNA-1403, is under an FDA clinical hold. The company said the clinical trial halt is due to a single report of Guillain- Barré syndrome, nerve damage that can be a complication of vaccines. The adverse event is under investigation. The company does not expect the clinical hold will affect the trial readout timeline in the northern hemisphere, where the study is already fully enrolled. The timing of a data readout will depend on case accruals. Second season enrollment is being prepared in the southern hemisphere. —The FDA placed a clinical hold on Ebvallo, a treatment for advanced cases of Epstein-Barr virus positive post-transplant lymphoproliferative disease. The hold came days after the FDA rejected the immunotherapy due to findings from an inspection of a third-party manufacturing facility. The company said the Ebvallo clinical hold relates to the issues flagged in the complete response letter. Ebvallo, which is made by engineering T cells from healthy donors, was approved in Europe in 2022.