Latest news with #Humira
Business Wire
a day ago
- Business
- Business Wire
Candid Therapeutics Advances Portfolio of Novel T-Cell Engagers into Five Autoimmune Diseases for Clinical Evaluation
SAN DIEGO--(BUSINESS WIRE)--Candid Therapeutics, Inc. ('Candid'), a clinical-stage biotechnology company redefining the treatment of autoimmune and inflammatory diseases through novel T-cell engagers (TCEs), today announced key operational and clinical milestones for its two lead clinical stage programs, cizutamig (BCMA TCE) and CND261 (CD20 TCE). Candid launched in the second half of 2024 with $370 million in financing and two in-licensed TCEs that had completed full Phase 1 dose escalation studies in oncology patients. Emerging clinical data with TCEs have solidified our confidence that TCEs can become the most compelling modality across a range of diseases. Share 'We founded Candid on the conviction that T-cell engagers would become the largest therapeutic class in autoimmune diseases, surpassing the commercial success of TNF inhibitors such as Humira,' said Dr. Ken Song, Chairman, President, and Chief Executive Officer of Candid. 'We are hyperfocused on execution to generate clinical data. Over the past few quarters, we have prioritized disease indications and built a foundation of key CMC and clinical operational activities to set a new benchmark for innovation, scale, and speed. Emerging clinical data with TCEs have solidified our confidence that TCEs can become the most compelling modality across a range of diseases.' Key Highlights Reinforcing Candid's Leadership Position: First patients dosed with cizutamig and CND261: Patients with refractory rheumatoid arthritis and systemic sclerosis have been dosed at therapeutically active doses. Both TCEs have been well tolerated and patients have shown early signs of promising clinical response and disease improvement. Industry-leading clinical study pipeline in motion: Clinical studies are now in progress for IgA Nephropathy, Myasthenia Gravis, Rheumatoid Arthritis, Systemic Lupus Erythematosus and Systemic Sclerosis. Additional clinical studies in high-value disease indications slated to launch in the 2H 2025. Studies are designed to evaluate safety, pharmacokinetics, pharmacodynamic effects, and early signs of efficacy in patients with immunology and inflammatory diseases. CMC activities completed to enable global clinical trials: Candid has invested significant resources to build an integrated Chemistry, Manufacturing, and Controls (CMC) infrastructure to support global development with the completion of several new drug product manufacturing runs. Subcutaneous dosing formulations for both cizutamig and CND261 have been established. Strategic establishment of China operations: To support clinical execution across multiple geographies, Candid has established a fully staffed legal entity in China. The China based team includes professionals with deep expertise in regulatory, clinical development, and clinical operations. With unmatched executional momentum and differentiated programs, Candid Therapeutics is defining a new future in immunology through its commitment to TCEs in autoimmune diseases. Additional trial initiations and clinical data disclosures are anticipated in the coming quarters. About Candid Therapeutics Candid Therapeutics is a clinical-stage biotechnology company focused on transforming the treatment of autoimmune and inflammatory diseases through novel T-cell engager (TCE) platforms. Candid is advancing two lead B-cell depleting TCE antibody drug candidates, with a goal to broadly explore the potential of TCEs across multiple autoimmune diseases by targeting different B-cell protein targets, as well as evaluating different depths of B-cell depletion. Established in 2024 and headquartered in San Diego, CA, Candid is led by a team of entrepreneurial executives who have a track record of advancing programs into and through development and is supported by a distinguished syndicate of premier life science investors. About Cizutamig Cizutamig is a bispecific antibody designed to simultaneously bind B-cell maturation antigen (BCMA) on B-cells and CD3 on T-cells, enabling T-cell–mediated cytotoxicity against BCMA-expressing B-cells. Originally developed and clinically evaluated in multiple myeloma, cizutamig has demonstrated patient experience in oncology settings and is now being investigated in autoimmune diseases where pathogenic B-cells play a critical role in disease progression. Cizutamig has the potential to deliver deep and selective B-cell depletion through its dual-targeting mechanism, offering a novel approach for treating a broad spectrum of immune-mediated disorders. About CND261 CND261 is a bispecific antibody designed to target CD20 on B-cells and CD3 on T-cells, enabling T-cell mediated cytotoxicity against CD20-expressing B-cells. Engineered with low CD3 affinity, CND261 is optimized to reduce the risk of excessive T-cell activation while maintaining potent and selective B-cell depletion. The molecule has demonstrated patient experience in B-cell malignancies and is now being investigated in autoimmune diseases where pathogenic B-cells contribute to disease progression. CND261 represents a promising therapeutic candidate for immune-mediated disorders with the potential for improved safety and efficacy through its targeted mechanism of action.
Yahoo
3 days ago
- Health
- Yahoo
AbbVie's migraine drug meets main goal in head-to-head study with topiramate
(Reuters) -AbbVie said on Wednesday its migraine drug met the main goal and was superior to a widely used generic treatment in a head-to head late-stage trial. The U.S. drugmaker has been expanding and banking on its neuroscience portfolio after its blockbuster arthritis drug Humira began facing competition from several less expensive biosimilar versions. The study's main goal was for the company's drug Qulipta, also known as Aquipta in Europe, to show a lower discontinuation rate due to undesired effect from the treatment than topiramate. Qulipta was stopped in 12.1% of patients, compared to 29.6% for the generic at 24 weeks. The European Medicines Agency's safety committee had in 2023 recommended pregnant women not use topiramate-containing medicines to prevent migraine or manage their body weight as their newborns could have a higher risk of neurodevelopmental disorders. AbbVie's study also met all secondary goals, with 64.1% patients on Qulipta seeing a 50% or more reduction in the average number of days per month when they experience migraine headaches. In comparison, 39.3% patients on topiramate saw a similar reduction. Qulipta, first approved in the United States in 2021, brought in $658 million in international sales last year.
Business Wire
10-06-2025
- Business
- Business Wire
Navitus Drug Trend Report: Keeping Costs Low for Plans and Members in an Era of Accelerating Inflation
MADISON, Wis.--(BUSINESS WIRE)-- Navitus, the nation's first transparent, pass-through pharmacy benefit manager (PBM), released its ninth annual Drug Trend Report today, revealing how commercial plan sponsors saved millions in prescription costs while maintaining high-quality member care. 30% of Navitus clients spent less in 2024 than in the previous year, while overall client book of business drug cost trend was managed to 7%. The data shows that medications such as glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are creating unprecedented financial pressure on plan sponsors as utilization for diabetes treatment increased 26% year-over-year. Overall health spending in the United States is nearly $4.9 trillion and projected to increase nearly 6% annually over the next decade. 1 A subset of this, prescription drug spending, was estimated to be $487 billion in 2024, an industry-wide 11.4% increase over the previous year, compared to 7% for Navitus clients. While the industry faces these escalating cost pressures, our latest Drug Trend Report highlights how Navitus continues to outperform industry trends and save clients money in this challenging environment, including companies such as Progressive Insurance. 'Navitus stands out for its commitment to transparency and managing to lowest net cost, which has significantly benefited Progressive and its members. From the outset, their 100% pass-through model has ensured that we receive the full value of manufacturer rebates and discounts, directly translating to reduced pharmacy costs,' said Heidi Minter, Data Analyst, Benefits & Design Services, Progressive Insurance. The Navitus Drug Trend Report revealed three critical trends influencing the broader industry: 1. 26% increase in GLP-1 RAs use for treatment of type 2 diabetes. While delivering significant clinical benefits, these medications are contributing substantially to pharmaceutical cost increases for benefit plans: Net trend in the diabetes category increased 8.5%, driven by growth in both the use of GLP-1 RAs, including Ozempic, Mounjaro and Trulicity, and a 16% increase in use of sodium-glucose cotransporter-2 inhibitors (SGLT-2s), including Farxiga and Jardiance. The prevalence and cost of GLP-1 RAs and SLGT-2s resulted in an overall unit cost increase of 3.0% for the diabetes category, in spite of the net cost decrease of more than 28% for insulin in 2024. 2. Biosimilars delivered $315 million in savings with a 60% reduction in Humira costs. Targeted immunomodulators (TIMs) treat a wide range of autoimmune disorders, from rheumatoid arthritis and psoriasis to inflammatory bowel diseases. The launch of Humira biosimilar alternatives in 2023 significantly changed the landscape of the category as these clinically-equivalent, much lower cost options were added to formulary. After adding biosimilars to formulary, Navitus took a decisive step to lower costs further by removing Humira from formulary in June 2024. This led to key results including: Over $315 million in upfront cost savings. 60% reduction in net costs per claim. 3. Specialty medication utilization increased 12%. Approximately 75% of new drug approvals have been for specialty or medical specialty agents, and that trend is expected to continue in the next two years. Key factors included: Oncology net trend increased more than 13%, driven by both higher utilization and unit cost: Utilization of newer breast cancer treatments (Kisqali, Verzenio) increased 20%, driving overall cost. In specialty dermatology, Dupixent (dupilumab) emerged as the most rapidly growing drug of 2024. The category saw a net trend increase of more than 45% and Dupixent represented 96% of category cost and utilization. While increased use of newer, more expensive agents like Kesimpta created upward pressure within the multiple sclerosis category, generics represented more than 50% of prescriptions filled at 10% of the cost. Expand 'Our annual Drug Trend Report confirms we were able to control year-over-year costs for commercial clients - both large and small - and deliver savings greater than the estimated industry averages,' said Sharon Faust, PharmD, MBA, CSP, Chief Pharmacy Officer, Navitus Health Solutions. 'Deploying generic-first strategies, facilitating adoption of new biosimilars, ensuring 100% pass-through of negotiated rebates and discounts, and supporting clinically appropriate prescribing, utilization and formulary management remain core to our focus.' Access the Navitus Drug Trend Report executive summary here: Methodology: The Navitus drug trend is calculated by comparing the net total cost per-member per-month (PMPM) for 2024 to that for 2023. Net cost PMPM represents full-year (Q1-Q4) data for total member copays and plan paid amounts minus manufacturer rebates and fees. This value is divided by the total number of members and by 12 months of the year. The data represents employer plan sponsors and health plans. In order to be included organizations must have been with Navitus for two full calendar years. * Due to varying coverage decisions by clients, GLP-1s for weight loss were not included in the Drug Trend Report, yet they still warrant thoughtful consideration and conversation in the overall picture of trend and future decisions. The DTR only represents prescriptions under the pharmacy benefit. 40% of Rx spend is through the medical benefit and warrants careful consideration by plans. Sources: About Navitus Navitus remains the nation's first transparent, pass-through pharmacy benefit manager (PBM). It uniquely brings clarity to drug pricing and takes costs out of the drug supply chain. Unlike traditional PBMs that generate profit by retaining an undisclosed portion of rebates and discounts negotiated with drug manufacturers and pharmacies, Navitus passes along the complete savings to clients, enabling them to make medication more affordable for their members. Navitus was established more than 20 years ago by Navitus Health Solutions, LLC, a pioneering pharmacy solutions company. The organization delivers a range of services through portfolio brands including Navitus, Lumicera, Archimedes. Owned by SSM Health and Costco, Navitus Health Solutions serves over 18 million lives across 800 clients including employers, unions, government plans, payors and health systems. For more information, please visit
Yahoo
10-06-2025
- Health
- Yahoo
Health New England to replace Humira coverage with lower-cost biosimilars
SPRINGFIELD, Mass. (WWLP) – Health New England announced Monday that it will shift coverage of the biologic drug Humira to more affordable FDA-approved biosimilars starting next month for members of its commercial health plans. Markey playing defense against GOP clean energy plans Effective July 1, the not-for-profit health insurer will cover Amjevita by Nuvaila and Hadlima instead of Humira, as part of a broader effort to manage rising health care costs while maintaining access to effective treatments. Humira is used to treat several chronic inflammatory conditions, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. 'Biologic medications like Humira are complex treatments that carry significant cost. Its biosimilars provide a meaningful opportunity to enhance affordability for the health care ecosystem while members continue to get the full benefits of the medication,' said Gary Tereso, PharmD, Director of Pharmacy Services at Health New England. Biologic drugs are made from living organisms and are typically more expensive than other medications. Biosimilars are developed to be nearly identical in safety, potency, and efficacy to the original biologic, but at a significantly lower cost. The shift in coverage is intended to make treatment more accessible and financially sustainable for members and employer groups alike. Health New England is directly reaching out to members who are currently prescribed Humira, along with their health care providers and pharmacies, to assist with the transition. The company said it will continue monitoring the biosimilar marketplace to ensure members receive both high-quality care and cost-effective treatment options. WWLP-22News, an NBC affiliate, began broadcasting in March 1953 to provide local news, network, syndicated, and local programming to western Massachusetts. Watch the 22News Digital Edition weekdays at 4 p.m. on Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
India Today
05-06-2025
- Business
- India Today
Dr Reddy's shares jump over 3% today. Here's why
Dr Reddy's Laboratories shares rose over 3% on Thursday, emerging as the top gainer on the Nifty Pharma index, which climbed 1.4%. Around 1:03 pm, the stock was up 3.39% at Rs 1, surge follows the announcement of a strategic partnership with US-listed biotech firm Alvotech to develop a biosimilar version of Merck's blockbuster cancer drug Keytruda (pembrolizumab). The PD-1 inhibitor, used to treat multiple cancer types, is expected to generate $29.5 billion in global sales in 2024, making it one of the most valuable targets in the biosimilars the agreement, Dr Reddy's and Alvotech will share development and manufacturing responsibilities and retain commercialisation rights globally, with a few Israeli, CEO of Dr Reddy's, called the deal a 'major step' in the company's oncology strategy. 'This collaboration enhances our capabilities in immuno-oncology and reinforces our focus on affordable, high-quality treatment options,' he which already markets biosimilars of Humira and Stelara, sees this partnership as a way to further leverage its R&D and manufacturing platform. 'This agreement demonstrates our ability to accelerate development of key biosimilars,' said chairman and CEO Rbert market has reacted positively to the development. While Dr Reddy's shares are down 5.3% on a year-to-date basis, they have gained 10.5% in the past month. Analysts see the move as a strategic bet to boost the company's global presence in the competitive biosimilar Direct described the Keytruda biosimilar as a 'decent pipeline opportunity' despite expected competition. At a forward 12-month PE of 18.8, Dr Reddy's remains the third-cheapest stock on the Nifty Pharma oncology being a core focus area and biosimilars gaining momentum globally, the collaboration with Alvotech marks a critical step in Dr Reddy's long-term growth The views, opinions, recommendations, and suggestions expressed by experts/brokerages in this article are their own and do not reflect the views of the India Today Group. It is advisable to consult a qualified broker or financial advisor before making any actual investment or trading choices.)Must Watch
