Latest news with #Calquence
Boston Globe
01-08-2025
- Health
- Boston Globe
Researchers forecast what Trump's bill will mean for patients: Debt and delayed care
About 2.5 million people may no longer have a personal doctor. About 1.6 million patients will take on medical debt. The lack of care may cause nearly 22,000 deaths annually. 'There's really no questioning the basic reality that you can't take health care away from 10 million people without causing many preventable deaths,' said Dr. Adam Gaffney, lead researcher on a team that explored the new law's impact. Here's a deeper look at the research and challenges that could develop. Advertisement How the law may affect coverage It will become harder for many people to enroll in Medicaid or individual insurance plans and then stay covered. Medicaid is a state and federally funded program that covers care for people with low incomes. States will have to verify every six months whether someone remains eligible for Medicaid. That could cause coverage lapses for people with incomes that fluctuate or for those who move and miss renewal paperwork. Many also are expected to lose coverage as states require Medicaid recipients to work, volunteer or go to school unless exempted. Related : Enrollment in Medicaid has swelled in recent years. Republicans are cutting back in part to help fund tax breaks and pay for other priorities like border security. They also say they are trying to root out waste and fraud by rightsizing Medicaid for the population it was initially designed to serve — mainly pregnant women, the disabled and children. Advertisement People covered through the Affordable Care Act's individual insurance marketplaces also will see shorter enrollment windows and no more automatic renewals. About the research Gaffney, of Harvard Medical School, and other researchers looked to past studies to measure how many people would experience detrimental effects, like going without prescriptions, from the upcoming changes. Gaffney updated the published analysis, which was originally based on the House version of the bill, at the AP's request. One study in particular was critical for their work: In 2008, Oregon offered a rare opportunity to compare groups of people enrolled in Medicaid with those who were not. The price for a bottle of 60 tablets of Amanda Schlesier's prescription chemotherapy pill, Calquence, printed on a pharmacy statement. Paul Sancya/Associated Press After a four-year period of frozen enrollment due to budget limitations, the state determined it could enroll 10,000 more people in Medicaid. It used a lottery system to make the selection amid high demand. That gave researchers a chance to follow people who got coverage and those who did not, similar to how scientists testing a new drug might compare patients taking it to those given a placebo. 'This is a gold standard research design because it replicates a randomized-controlled trial,' said Christine Eibner, a senior economist at RAND Corp. who was not involved in the study. Related : Applying results from that study and other research to the recent CBO estimate allowed Gaffney and other researchers to estimate specific effects of losing coverage. 'By taking coverage away, we are putting patients in a terrible position,' said Gaffney, a former president of Physicians for a National Health Program. Care could grow complicated Amanda Schlesier went four days without her cancer treatment Calquence this spring and wound up in a local emergency room, delirious with pain. Advertisement The leukemia patient worries about what might happen if she stops treatment again for a longer stretch because she's lost Medicaid. 'God forbid I forget to fill out a page of documentation, and suddenly I lose access to my medication or my doctors or any of the treatment that I've been going through,' the 33-year-old Farmington Hills, Michigan, resident said. People can still receive care when they don't have coverage, but important steps often are delayed, said Dr. Gwen Nichols, chief medical officer of The Leukemia & Lymphoma Society. Patients may be able to visit a doctor, but they would have to line up coverage or help before they can receive expensive chemotherapy. Diagnosis also may be delayed. Meanwhile, the patient's cancer continues to grow. 'It's a ticking time bomb,' Nichols said. Preventive care may lapse The first thing patients often ditch when they lose coverage are screenings designed to catch health problems before they become serious, said Dr. Jen Brull, president of the American Academy of Family Physicians. That could mean patients skip tests for high cholesterol, which can contribute to heart disease, or colonoscopies that detect cancer. Researchers forecast that a half million fewer women will have gotten a mammogram within the past year by 2034. When patients struggle financially and lose coverage, they focus on things like keeping a place to live and food on their table, said Brull, a Fort Collins, Colorado, physician. 'Seeing a doctor because you don't want to get sick feels like a much lower priority,' Brull said. Dennis Heaphy, an advocate with the Massachusetts Disability Policy Consortium, said he would likely be in a nursing home without MassHealth support, during a panel at the Cambridge Health Alliance Revere Care Center on May 27. To his left, Governor Maura Healey and Senator Elizabeth Warren. To his right, Senator Ed Markey. Brett Phelps for The Boston Globe Financial pressure can build Patients start taking financial hits at all ends of care when they lose coverage. They may have to pay up front or start a payment plan before they receive care, said Erin Bradshaw, an executive vice president with the nonprofit Patient Advocate Foundation, which helps people with medical bills. Advertisement Anyone with an outstanding balance will have to pay it before the next appointment. Related : Financial assistance may be available, but patients don't always know about it. Getting help also may take time and require the submission of tax returns, pay stubs or some validation that the patient no longer has coverage. Bradshaw said letters stating that a patient has lost Medicaid sometimes arrive a couple months after the fact. That can contribute to treatment delays or missed medication doses. Some patients also try to avoid financial stress by skipping care. Schlesier said she delayed seeing a doctor when she first felt symptoms of her cancer returning because she had no coverage at the time. Staying on medications If prescriptions are too expensive, patients may simply not get them or split the doses to stretch the medicine. For Thomas Harper, it's a question of priorities. 'Sometimes you have to make a choice, how well do you want to eat this week versus taking your medicine,' he said. The West Monroe, Louisiana, truck driver has around $300 a month in prescriptions as he deals with diabetes and recovers from non-Hodgkin lymphoma, a type of blood cancer. Harper, 57, recently returned to work. That meant he lost Medicaid, which covered more of his prescription costs. He's balancing buying his meds with shopping for healthy food that keeps his blood sugar in check and builds his immune system. 'I'll survive, but I know there's people out there that cannot survive without Medicaid,' he said. AP video journalist Laura Bargfeld contributed to this report. Advertisement
Yahoo
21-05-2025
- Business
- Yahoo
AstraZeneca Stock Declines 6% in 3 Months: Time to Buy the Dip?
AstraZeneca AZN stock has declined 6.4% in the past three months. Although AstraZeneca faces its share of challenges, a significant portion of this price decline is attributed to broader market uncertainties and a volatile macroeconomic environment. The sky-high tariffs imposed by the United States and retaliatory tariffs by China and some other countries hurt global stock markets. Though the massive tariffs imposed by the United States and China are now on a pause, it is only a temporary suspension, and no one knows what will happen after the 90-day tariff suspension ends. The uncertainty around tariffs and trade production measures remains, slowing down economic growth. Although pharmaceuticals have been exempted from tariffs in the first round, they could be Trump's target in the next round, considering the President's goal to shift pharmaceutical production back to the United States, primarily from European and Asian countries. Trump and the Republican government also continue to stress on the control of drug prices with the latest attempt being his 'most favored nations' policy.' Let's understand AZN's strengths and weaknesses to better analyze how to play the stock in an uncertain macro environment. AstraZeneca boasts a diversified geographical footprint as well as a product portfolio with several blockbuster medicines. AstraZeneca now has 16 blockbuster medicines in its portfolio with sales exceeding $1 billion, including Tagrisso, Fasenra, Farxiga, Imfinzi, Lynparza (partnered with Merck [MRK]), Calquence and Ultomiris. These drugs are driving the company's top line, backed by increasing demand trends. The company is confident that the growth will continue in 2025. Almost every new product it has launched in recent years has done well. Newer drugs like Wainua, Airsupra, Saphnelo, Datroway (partnered with Daiichi Sankyo) and Truqap are also expected to continue to contribute to top-line growth in 2025. Oncology is AstraZeneca's biggest segment. The company is working on strengthening its oncology product portfolio through label expansions of existing products and progressing oncology pipeline candidates. Oncology sales (comprising around 41% of AstraZeneca's total revenues) rose 13% in the first quarter of 2025, generating $5.6 billion in sales. The strong oncology performance is being driven by medicines such as Tagrisso, Merck-partnered Lynparza, Imfinzi, Calquence and Daiichi Sankyo-partnered Enhertu. A key new cancer drug approval was that of Truqap for HR-positive, HER2-negative (HR+ HER2-) breast cancer. The drug has seen a robust launch, recording sales of $430 million in 2024 and $132 million in the first quarter of 2025. In January this year, AstraZeneca and partner Daiichi's drug, Datroway, was approved by the FDA for HR+ HER2- breast cancer, while a regulatory application is under review for EGFR-mutated non-small cell lung cancer (NSCLC). Datroway witnessed encouraging early launch signals in the United States. AstraZeneca expects continued growth of its oncology medicines in 2025, particularly Tagrisso, Enhertu and Imfinzi, despite the incremental impact of the Part D redesign. The impact of Part D redesign hurt sales of AZN's older drugs, Tagrisso, Lynparza and Ultomiris, as well as newer drugs, Truqap and Wainua, in the United States in the first quarter of 2025, with the trend expected to continue through the rest of the year. AstraZeneca expects Farxiga and Lynparza to be included in the volume-based procurement plans in China in mid-2025, which can hurt sales of these drugs in the country. Pricing and competitive pressure in Europe and generic competition in some emerging markets are expected to hurt sales of some drugs. Brilinta generics are expected to be launched in the United States in 2025. This will hurt sales of the drug. Biosimilar versions of Soliris were launched in the United States in March 2025, which, along with successful conversion to Ultomiris, biosimilar pressure in Europe and unfavorable order timing in certain tender markets, is expected to lead to a continuous decline in sales of Soliris. AstraZeneca is facing ongoing investigations at its China subsidiary. The Chinese authorities are investigating some current and former AstraZeneca employees at its China subsidiary for medical insurance fraud, illegal drug importation and personal information breaches. AZN stock has risen 8.2% so far this year againsta decrease of 3.1% for the industry. The stock has also outperformed the sector and S&P 500 index, as seen in the chart below. Image Source: Zacks Investment Research From a valuation standpoint, AstraZeneca is slightly expensive. Going by the price/earnings ratio, the company's shares currently trade at 14.93 forward earnings, slightly higher than 14.74 for the industry. However, AZN's stock is trading below its 5-year mean of 18.05. The stock is also much cheaper than other large drugmakers like Eli Lilly LLY and Novo Nordisk NVO. Eli Lilly and Novo Nordisk currently dominate the obesity space. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2025 earnings has risen from $4.47 per share to $4.50 per share over the past 60 days. For 2026, earnings estimates have risen from $4.95 per share to $4.98 per share over the same timeframe. Image Source: Zacks Investment Research Despite the potential impact from Part D redesign, AstraZeneca expects total revenues to grow by a high single-digit percentage at CER in 2025. Growth momentum in Oncology and CVRM(cardiovascular, renal and metabolism) segments is expected to continue in 2025. However, in Rare Disease, though AstraZeneca expects growth in 2025, it will be at a slower pace than in 2024. Regarding the potential impact of tariffs, AstraZeneca had a positive tone on the first-quarter conference call. The company said it has limited commercialized finished medicines imported to the United States from China, which lowers its exposure to potential China tariffs on pharmaceuticals. It also has a substantial and growing manufacturing footprint in the United States, and the majority of its medicines sold in the United States are manufactured domestically. It does import some medicines from Europe but believes that if tariffs on pharmaceutical imports from Europe are implemented in a similar range as other industries, it will be manageable and allow the company to remain within its guidance range for EPS. In 2025, AstraZeneca expects core EPS to increase by a low double-digit percentage. Backed by its new products and pipeline drugs, AstraZeneca believes it can post industry-leading top-line growth in the 2025-2030 period. AstraZeneca expects to generate$80 billion in total revenues by 2030, a significant increase from the $54 billion it generated in 2024. By the said time frame, AstraZeneca plans to launch 20 new medicines, with nine new medicines already launched/approved. It believes that many of these new medicines will have the potential to generate more than $5 billion in peak-year revenues. The company is also on track to achieve a mid-30s percentage core operating margin by 2026 Considering AZN's growth prospects, investors may take advantage of the recent dip and consider buying this Zacks Rank #2 (Buy) stock, more so as it is trading below its five-year mean. Consistently rising estimates also indicate analysts' optimistic outlook for growth. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Business
- Yahoo
BioInvent Announces Updated Phase 2a Triple Combination Arm Data of BI-1206, rituximab, and Calquence for the Treatment of Non-Hodgkin's Lymphoma
Latest preliminary data show continued promising clinical activity in NHL patients, with two complete responses (CR), three partial responses (PR), and three stable disease (SD) as best clinical response in the first eight patients evaluated Results equate to an objective response rate (CRs and PRs) of 63% Data from an earlier cutoff date in February are included in an abstract published today by the European Hematology Association (EHA) 2025 conference LUND, SE / / May 14, 2025 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces latest updated data from the ongoing Phase 2a study of BI-1206 in combination with rituximab and Calquence® (acalabrutinib) for the treatment of non-Hodgkin's lymphoma (NHL). Additionally today, an abstract containing data from an earlier February cutoff date has been published by the European Hematology Association (EHA) as part of its 2025 congress due to take place June 12-15 in Milan, Italy. The data released today show the first eight patients in the triple combination arm of BioInvent's ongoing Phase 2a in non-Hodgkin's lymphoma. All patients exhibited disease control at first assessment (DCR 100%), and results show an overall objective response rate of 63% with two patients achieving a complete response (CR) and three patients with partial responses (PR). Stable disease (SD) was observed in the three remaining patients. The combination has been well tolerated in all patients treated at the cut-off-date. These data are further updated compared to the data included in the EHA abstract. "We continue to be encouraged by the early data demonstrating robust clinical activity and manageable safety profile in the ongoing triple combination arm of the Phase 2a study of BI-1206 in combination with rituximab and Calquence in NHL patients who have relapsed after previous lines of treatment," said Martin Welschof, Chief Executive Officer of BioInvent. "The objective responses observed to date highlight the potential of the combination to improve outcomes and overcome resistance, a result we believe is driven by the mechanism of action of BI-1206. Previously we have demonstrated that BI-1206 can restore response to rituximab in relapsed/refractory patients. Now we demonstrate that a BTK inhibitor may be added to this combination without compromising safety. We look forward to advancing the clinical development of this promising and highly convenient treatment." Details of the EHA abstract released today are below: Title: BI-1206, an Antibody Targeting FcγRIIB, given in Combination with Rituximab and Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin's LymphomaLead Author: Laura Fogliatto, Hospital de Clínicas de Porto Alegre, Porto Alegre, BrazilAbstract Number: PB3180 About the studyThe triple combination arm in the ongoing Phase 2a study combines the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib) in subjects with indolent B-cell non-Hodgkin's lymphoma (NHL) relapsed or refractory to rituximab. Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the combination arm. About BI-1206BI-1206 is one of BioInvent's lead drug candidates and is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The drug candidate is evaluated in two separate clinical programs, one for the treatment of non-Hodgkin's lymphoma (NHL, a type of blood cancer) and one for the treatment of solid tumors. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: BioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release. This information is information that BioInvent International is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-05-14 15:30 CEST. Attachments BioInvent Announces Updated Phase 2a Triple Combination Arm Data of BI-1206, rituximab, and Calquence for the treatment of non-Hodgkin's lymphoma SOURCE: BioInvent International View the original press release on ACCESS Newswire
Yahoo
31-03-2025
- Business
- Yahoo
FDA Approves AstraZeneca's Imfinzi As First Perioperative Immunotherapy For Muscle-Invasive Bladder Cancer Patients
The U.S. Food and Drug Administration (FDA) on Monday approved AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) for adult patients with muscle-invasive bladder cancer (MIBC). The FDA approval was based on results from the NIAGARA Phase 3 trial. In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm. Also Read: The estimated median event-free survival (EFS) has not yet been reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event-free at two years compared to 59.8% in the comparator arm. Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy. Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm. Concurrently, AstraZeneca's Calquence (acalabrutinib) in combination with bendamustine and rituximab was recommended for approval in the European Union for adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation. The positive opinion was based on the ECHO Phase 3 trial results. Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy. Median PFS was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone. Price Action: AZN stock is down 0.86% at $73.16 at the last check Monday. Read Next:Image by Robert Way via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? ASTRAZENECA (AZN): Free Stock Analysis Report This article FDA Approves AstraZeneca's Imfinzi As First Perioperative Immunotherapy For Muscle-Invasive Bladder Cancer Patients originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
