Bausch Health Cos., Inc.

As a wave of individualized cancer vaccines advances, the FDA's vaccine czar Peter Marks, M.D., Ph.D., is weighing new regulatory questions surrounding the products. As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite AI-related unknowns. “We are ready to review—we’re open for business,” Marks, director of the FDA’s Center for Biologics Evaluation and Research, said of cancer vaccines at the 2024 World Vaccine Congress (WVC). “We have therapeutic cancer vaccines coming in; I think we would review them very much like we could review potentially a CAR-T cell or other therapeutic products,” Marks said. The FDA has approved a cancer vaccine before, namely Dendreon’s prostate cancer shot Provenge. Although the next wave of therapeutic cancer vaccines aim to prove efficacy through familiar clinical endpoints—such as tumor progression and overall survival—the novelty of their tech raises new regulatory questions. And neither the FDA nor the biopharma industry seem to have the full set of answers right now. For the production of CAR-T therapies and Provenge, a patient’s own immune cells are collected and then manipulated to recognize cancer cells. In both cases, although the final products differ based on the patient’s cells, the starting components and the processing steps are the same in nature. For Moderna and Merck’s mRNA candidate mRNA-4157, though, AI dictates how the individualized vaccine should be formulated to attack cancer. The platform sequences a patient’s tumor and healthy tissue and then uses AI to capture the most relevant tumor-specific mutational signatures. Neoantigens identified this way form the basis of the vaccine construct, and the resulting proteins can be very different between individuals. The goal is to induce an immune response against tumors bearing those biomarkers. As AI is a core component of the program, Moderna expects the FDA will need to inspect its algorithm as part of the review of vaccines like mRNA-4157, also known as V940, Kyle Holen, Moderna’s head of development of therapeutics and oncology, told Fierce Biotech on the sidelines of WVC. “We have to put our algorithm on a hard drive, put it in armored truck and have it shipped to the FDA,” Holen said. AI algorithms are known to evolve as they absorb new information. But to protect the integrity of a clinical trial for an AI-based vaccine, Moderna had to “lock down” the algorithm before the study to avoid any changes that may have confounded the results, Holen added. All of this raises a new regulatory question: How much change to the AI algorithm is allowed before the vaccine should be considered a completely new product? “We don’t know,” Holen said. “Nobody knows. We’re in, like, no-man’s land here, because no one’s ever done this.” Moderna has started these discussions internally, but the company doesn’t yet have a conclusion, he added. “I think when the phase 3 trial is complete, you should understand all the data that we generated and use that to train the model and to create a new model,” Holen said during a panel discussion at WVC. “But ultimately what that’s going to result in is the requirement for another randomized trial of the new model versus the old model.” Moderna has talked to the FDA and learned that changing the vendor for genome sequencing and the range in the number of antigens would be considered major changes to the program, Holen said. But it's unclear whether those adjustments would require a supplemental application or a brand-new product filing if they came after an initial approval, he said. “It’s an unexplored space in drug development, when you have the ability to change your drug and how it works and how you manufacture your drug continuously,” Holen said. FDA’s Marks appears to have a more stringent criterion for considering updates to cancer vaccines as new products. “I think the assumption is that most things are going to be new products unless they actually are similar enough to an old one that you can consider for a vaccine, that it’s like a strain change,” Marks told Fierce Biotech. It would be hard to imagine requiring completely new reviews or large randomized clinical trials for every update to a cancer vaccine. That’s why Marks believes the FDA’s yet-to-be-formalized platform technology designation could be helpful. The FDA recently issued draft guidance on the “advanced manufacturing technology” designation program, which was developed as part of the Food and Drug Omnibus Reform Act of 2022. The initiative is viewed as a step to facilitate the development of products based on novel technologies to improve the drug production process. The agency is still separately working on the specifics of the “platform” designation. The idea would be that products developed with the same platform technologies may enjoy streamlined reviews for subsequent advances. The FDA has had the “platform” idea for some time. But it hasn’t really applied the idea to the fullest extent possible, Marks said. “I think the mRNA platforms are going to force us to really try to lean into that," Marks added.

LAVAL, QC / ACCESSWIRE / April 3, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), today announced the first public drug plan listings for PrUCERIS® (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults.1 UCERIS is now available for patients through the public drug plans of five Canadian provinces: Ontario, Quebec, Saskatchewan, New Brunswick and Nova Scotia. These first public drug plan listings for UCERIS come following the signing of a letter of intent with the pan-Canadian Pharmaceutical Alliance (pCPA) early this year, setting out the parameters for listing of the treatment by the public drug plans of the provinces, territories and federal government. "Bausch Health is very pleased that patients with distal ulcerative colitis in five provinces, including the two largest, will now have access to UCERIS and we look forward to the rapid completion of listing agreements with other public drug plans so more Canadians will have insured access to this new therapy," said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. "We want to provide additional effective treatment options to Canadians." UCERIS, part of the Company's growing gastrointestinal franchise, has been available in Canada by prescription since September 2023 and is covered by the majority of private insurance drug plans in Canada. "Living with ulcerative colitis means experiencing painful, frequent bowel movements, which can also be bloody. Effective treatments for this chronic inflammatory bowel disease are vital to have any quality of life," said Gail Attara, President and Chief Executive Officer of the Gastrointestinal Society, a patient group known by its badgut.org website. "We are pleased that public drug plans in Canada are starting to make the new ulcerative colitis treatment UCERIS available as a covered benefit and look forward to their example being followed by all drug insurance plans across Canada." UCERIS is the only glucocorticosteroid rectal foam available in Canada indicated for the induction of remission in adult patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.1 In a study comparing budesonide foam and budesonide enema in patients with active distal ulcerative colitis, most patients (84%) preferred the foam formulation because of its better tolerability and easier application.2 Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.3 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).3 In the two clinical studies on which the approval of UCERIS rectal aerosol foam was based, a significantly higher proportion of patients in the UCERIS group than in the placebo group were in remission at Week 6 (38.3% and 44.0% vs. 25.8% and 22.4% respectively, pooled p<0.0001) and had a rectal bleeding sub-score of 0 at Week 6 (46.6% and 50.0% vs. 28.0% and 28.6% respectively, pooled p<0.0001). There was also a higher proportion of patients in the UCERIS group than in the placebo group with an endoscopy sub-score of 0 or 1 at Week 6 (55.6% and 56.0% vs. 43.2% and 36.7% respectively.1 About Bausch Health Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, healthcare professionals, employees and investors. For more information, visit and connect with us on Twitter and LinkedIn. The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at . REFERENCES 1 Bausch Health, Canada Inc., UCERIS rectal foam Product Monograph, 2 Gross V, et al, Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis, Aliment Pharmacol Ther. 2006;23(2):303-312. 3 IBD Clinic, University of Alberta: Investor Contact: Media Contact: Kevin Wiggins ir@bauschhealth.com corporate.communications@bauschhealth.com (877) 281-6642 (toll free) (908) 927-1198 SOURCE: Bausch Health Companies Inc. View the original press release on accesswire.com

GuideWell delivers on commitment to health equity and community well-being, providing $28.4 million in charitable giving to improve the health of local communities. JACKSONVILLE, Fla., March 27, 2024 /PRNewswire/ -- GuideWell Mutual Holding Corporation (GuideWell), a leading not-for-profit, policyholder-owned health solutions organization, released its 2023 Impact Report which details the company's progress in its efforts to improve health outcomes and increase access to quality, affordable health care. The report details the strides GuideWell has made to advance an inclusive workplace, increase supplier diversity, strengthen food security, provide comprehensive mental well-being resources, and reduce health disparities. Continue Reading "We are committed to serving as a force for good and improving the health care system for everyone." - Pat Geraghty, President & CEO of GuideWell and Florida Blue Post this GuideWell publishes 2023 Impact Report "At GuideWell, to help people truly live healthier lives, we are constantly thinking beyond the boundaries of the traditional health care system and engaging actively with partners in our communities, collaborating to find and implement real solutions that change people's lives," said Pat Geraghty, president and CEO of GuideWell and its largest subsidiary, the health solutions company Florida Blue. "We are committed to serving as a force for good and improving the health care system for everyone." In 2023, through its joint venture with Sanitas Medical Centers (Sanitas USA), GuideWell opened eight new clinics and plans to open 30 additional locations over the next three years, building on the organization's commitment to increasing access to quality whole-person, customized, coordinated care throughout Florida. GuideWell works to better serve diverse communities by understanding their unique health challenges. Last year, it launched qualitative studies on multicultural engagement and health literacy and provided culturally relevant experiences for its customers. It also made strategic hyperlocal investments to support those with the greatest needs, spearheading initiatives that target major issues, such as diabetes, social isolation, and generational poverty. Led by its Chief Health Equity Officer, Dr. Kelli Tice, GuideWell created a whole health index to measure member health holistically, taking community, social, and clinical drivers into account. The index monitors disparities to identify areas of improvement and indicators to help guide future efforts. Additional 2023 report highlights include: $28.4 million provided in charitable giving to improve the health of local communities $1.5 million invested to address generational poverty in six ZIP codes $4 million allocated to health equity initiatives through the Equity Alliance $3.2 million donated to improve mental well-being for Florida residents 2.12% reduction in disparate health outcomes for Black Florida Blue members $250,000 awarded to alleviate social isolation and loneliness in Puerto Rico 52.9 million meals supplied as part of food security programs 20% diverse supplier spend achieved across GuideWell companies, exceeding its annual target of 14% 48.7% reduction in greenhouse gas emissions since 2017 The GuideWell Board of Directors is responsible for providing oversight and direction for GuideWell's business and community impact strategies, setting specific metrics in consultation with external subject matter experts, and ensuring accountability across the organization. The GuideWell enterprise includes Florida Blue, the leading health insurance company in Florida, and Triple-S Management, a leading health care services company in Puerto Rico. For more information and to view the full report, visit . About GuideWell GuideWell comprises Florida's Blue Cross Blue Shield plan, Florida Blue, which is the leading health insurer in Florida; Triple-S Management, Puerto Rico's Blue Cross Blue Shield plan and a leading health care services company on the island; GuideWell Health, a portfolio of clinical delivery organizations; PopHealthCare and its value-based national medical group Emcara Health; GuideWell Source, which provides administrative services to federal health care programs; and WebTPA, a market leading administrator of self-funded employer health plans. The company holds majority or significant interests in a range of health solutions companies including Lucet, a behavioral health care company that provides technology-enabled support to payers, providers, and health plan members. Through a joint venture with Keralty, a multinational health business group with more than 40 years of global experience, GuideWell is expanding care delivery across Florida through more than 48 Sanitas direct care delivery locations. GuideWell serves 38.5 million people across 50 states, Puerto Rico and the U.S. Virgin Islands, including more than 6 million individuals in Florida. For additional information visit . For the latest news and content, visit the GuideWell Newsroom, and follow GuideWell on Facebook, LinkedIn, and Instagram @LifeAtGuideWell; and X (formerly Twitter) @_GuideWell. SOURCE GuideWell