Abortion

New Survey by Stagwell (STGW)'s The Harris Poll Reveals Critical Gaps in Public Awareness and Support Surrounding Pregnancy and Infant Loss in the U.S. NEW YORK, Oct. 15, 2024 /PRNewswire/ -- In honor of Pregnancy and Infant Loss Remembrance Day (Oct 15), The Harris Poll, a Stagwell Agency, is releasing additional data from its second annual State of Maternal Health Report, bringing to light alarming gaps in public understanding of and support systems relating to pregnancy and infant loss across the United States. Key findings from the survey, conducted online in April of 2024, indicate significant disparities when it comes to knowledge of infant mortality rates in the U.S., and confirm a shocking lack of support for those experiencing loss. "These statistics just graze the surface of such a significant and delicate issue for women, and families, and the lack of support offered to them," expressed Christina Lojek, Research Manager at The Harris Poll. "As someone who has had the unfortunate experience of facing a pregnancy loss and feeling like I was expected to just jump back into normal life like nothing happened, I whole-heartedly believe that things could have been better on many accounts if proper education and support standards were in place." According to March of Dimes, stillbirth affects about 1 in 160 births in the U.S., and about 10 to 20 percent of pregnancies end in miscarriage. Furthermore, the U.S. — one of the most developed nations in the world – is not among those with the lowest rates of infant deaths (or the death of an infant before his or her first birthday). Less than one third of Americans (29%) know that the U.S. does not have one of the lowest rates of infant mortality among developed countries. And less than half of Americans (45%) know that Black and American Indian/Alaska native babies are twice as likely as white babies to die before their first birthday. This knowledge gap underscores a critical need for increased awareness and action. The study also highlights an urgent call for policy changes regarding parental leave following the loss of a baby. About 2 in 5 women who have been pregnant or given birth (39%) believe that employers should offer the same amount of paid leave for parents who experience a miscarriage or stillbirth as they do for those taking maternity or paternity leave. This sentiment is even stronger among younger women aged 18-34, where about half (51%) support such equality in parental leave policies. Furthermore, there is an overwhelming need for supportive measures post-miscarriage or stillbirth. One in 7 women who have been pregnant or given birth (14%) state that their pregnancy/birth experience(s) would have been easier/better if they were provided support after a miscarriage/stillbirth, with a dramatic increase to nearly one in four (23%) among younger women aged 18-34. These stats, which are among all women and include those who did not experience loss, would undoubtedly be much higher if just looking at those who did in fact suffer a miscarriage or stillbirth. Essential services such as medical support for physical healing, information on therapy and support groups, and memorabilia like footprints or photographs could provide substantial relief for grieving parents. During Pregnancy and Infant Loss Awareness Month (October), and especially today, these findings are even more unnerving as it is clear there is not enough being done to support these individuals and families through this difficult, grief-filled journey. Sadly, it is evident that the U.S. is severely behind when it comes to preventing and addressing pregnancy and infant loss, supporting mothers and families after loss, which should serve as a call to action for policy makers, healthcare providers, and employers alike. If you or someone you know has experienced a pregnancy or infant loss, please consider checking out the below resources/information for support. Survey Method: The 2024 State of Maternal Health survey was conducted online in the U.S. by The Harris Poll April 2-4, 2024 among 2,061 U.S. adults ages 18+, among whom 1,116 are women, and 701 are women who are currently pregnant or have ever been pregnant. The sampling precision of Harris online polls is measured by using a Bayesian credible interval. For this study, the sample data is accurate to within +/- 2.5 percentage points using a 95% confidence level. This credible interval will be wider among subsets of the surveyed population of interest. For complete survey methodology, including weighting variables and subgroup sample sizes, please contact [email protected]. About The Harris Poll The Harris Poll is a global consulting and market research firm that strives to reveal the authentic values of modern society to inspire leaders to create a better tomorrow. It works with clients in three primary areas: building twenty-first-century corporate reputation, crafting brand strategy and performance tracking, and earning organic media through public relations research. One of the longest-running surveys in the U.S., The Harris Poll has tracked public opinion, motivations and social sentiment since 1963, and is now part of Stagwell, the challenger holding company built to transform marketing. To learn more, please visit Contact: Christina Lojek [email protected] SOURCE Stagwell Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

FRIENDSWOOD, Texas--( BUSINESS WIRE )--Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will present new data supporting the ability of its TissueCypher Barrett’s Esophagus test (TSP-9) to independently predict risk of progression to esophageal cancer in patients with Barrett’s esophagus (BE) at the American Foregut Society (AFS) 2024 Annual Meeting, being held Sept. 25-29, 2024, in Denver. “The large majority of patients in BE surveillance programs have non-dysplastic BE (NDBE), and so they fall into what is considered a low-risk category in which they are advised to see their doctor every three to five years for an endoscopy,” said Rhonda F. Souza, M.D., gastroenterologist, co-director of the Center for Esophageal Research at Baylor Scott & White Research Institute and co-director of the Center for Esophageal Diseases at Baylor University Medical Center in Dallas. “However, many BE patients who go on to develop esophageal cancer come from this allegedly low-risk group. Our study shows that traditional clinicopathologic variables are not helpful in predicting the risk of neoplastic progression in patients with NDBE, and TSP-9 testing is far superior in this regard. Rather than delaying surveillance for years, we think that patients identified as high-risk by TSP-9 would benefit from more intensive surveillance or endoscopic eradication therapy.” “TissueCypher is the first test of its kind developed to offer a solution for this clinical challenge,” said Rebecca Critchley-Thorne, Ph.D., vice president of research and development at Castle Biosciences. “The test continues to demonstrate its substantial value in helping physicians tailor their treatment plans for BE patients based on their likelihood of developing esophageal cancer.” Details regarding Castle’s presentations at AFS 2024 are included below: Oral presentation: TissueCypher is the strongest independent predictor of progression in patients with Barrett’s esophagus Presenting Author: Rhonda F. Souza, M.D Date & Time: Saturday, Sept. 28, 11:50 a.m.–12 p.m. Mountain Time Summary: The study aimed to evaluate whether routinely available clinicopathologic factors used to risk stratify patients with BE, including age, sex, BE segment length, hiatal hernia and original pathology diagnosis (non-dysplastic Barrett’s esophagus (NDBE), indefinite for dysplasia (IND) and low-grade dysplasia (LGD)), could be combined with the patient’s TissueCypher risk score to improve the accuracy of predicting progression to high grade dysplasia (HGD) or esophageal cancer within five years. The study showed that the addition of clinicopathologic factors did not improve the predictive performance of the TissueCypher test; in fact, TissueCypher, used alone, was the strongest predictor of progression. In patients with NDBE, TissueCypher was the only significant predictor of progression, supporting its significant clinical utility in identifying high-risk patients in this large population to help determine which may benefit from increased surveillance or early interventions to prevent cancer. Poster # 42: The tissue systems pathology test guides risk-aligned management decisions in patients with non-dysplastic Barrett's esophagus Date & Time: Friday, Sept. 27, 12:45–12:50 p.m. Mountain Time Summary: This study evaluated the clinical utility of the TissueCypher test in guiding risk-aligned clinical management decisions for a series of consecutive patients with NDBE (n=14) at an expert foregut surgery center. The patients received prospective TissueCypher testing, and the ordering physician completed a questionnaire describing their reason for ordering the test, their management plan before and after receiving the test results, and how the test results impacted their management decisions. The study data showed a significant association between patients’ TissueCypher risk class and subsequent management decisions (P=0.01099), with 86% of patients being managed in alignment with their risk of progression to HGD or esophageal cancer according to the test’s results. Use of TissueCypher test results led to upstaged management in 21% of patients, such as the use of endoscopic eradication therapy to help prevent progression to esophageal cancer. The test also supported long-interval surveillance (3-5 years), consistent with guideline recommendations, in 90% of low-risk patients. These data highlight the clinical value of the TissueCypher test in guiding risk-aligned management decisions for patients with NDBE and increasing physician confidence in those decisions. About TissueCypher ® Barrett’s Esophagus Test The TissueCypher Barrett’s Esophagus test is Castle’s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). The TissueCypher Barrett’s Esophagus test is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (NDBE), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by 14 peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022. Learn more at www.CastleBiosciences.com . About Castle Biosciences Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors. Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn , Facebook , X and Instagram . DecisionDx-Melanoma, DecisionDx-CM Seq , DecisionDx-SCC, MyPath Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UM Seq are trademarks of Castle Biosciences, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: (i) Castle’s ability to advance care for patients with BE; (ii) the ability of the TissueCypher test to be the strongest predictor of risk of progression to esophageal cancer in patients with BE based on published studies; and (iii) the ability of the TissueCypher test to guide important patient management decisions, including upstaging care for high-risk patients and supporting long-interval surveillance for patients at low risk of progression. The words “can,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results shown in this study, including with respect to the discussion of TissueCypher in this press release; actual application of our TissueCypher test may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

01 行业新闻 丨药监局曝光多起涉司美格鲁肽违法案例过 9月18日，国家药监局公布了4起药品网络销售违法违规典型案例。其中，3个案例都与司美格鲁肽相关。这三个案例分别发生在浙江、广东、安徽三地，涉案货值金额最高的达到3500万元，系在广东发现的违法生产经营假药案。国家药监局提醒，司美格鲁肽等药品属处方药，需要遵从医嘱。从非正规渠道购入的药品，可能存在成分不明、计量不准、掺杂使假等质量问题，无法保证治疗效果，还可能引发严重毒性反应，威胁生命安全。（健识局） 丨药监局：在部分地区开展创新和临床急需生物制品分段生产试点 9月18日，国务院新闻办公室举行“推动高质量发展”系列主题新闻发布会。国家药品监督管理局（NMPA）局长李利在新闻发布会上表示：1、支持医药行业开放合作。加强国际通用监管规则在国内的转化实施，支持开展国际多中心临床试验，促进全球药物在中国同步研发、同步申报、同步审评、同步上市。2、探索生物制品分段生产模式，在部分地区开展创新和临床急需生物制品分段生产试点。3、加大对医药进出口贸易的支持力度，加快境外已上市新药在境内上市审批，鼓励跨国企业把原研化学药品、生物制品和高端医疗装备等转移到国内生产。完善药品出口销售证明相关政策，鼓励我国更多医药企业走出国门参与国际贸易，让中国药品造福全人类。（药通社） 丨湖南对未过评产品价格纠偏 9月18日，湖南省公共资源交易红心发布《关于对挂网药品（2024年第一批）进行价格纠偏的通知》明确，最小制剂价格高于同规格参比制剂、过评药品最低挂网价格等药品均不符合本省挂网规则，需要实施挂网价格纠偏。本次遭遇湖南省点名的挂网价格不合理，很多都是临床常用药，不乏进口药，包括诺华的沙库巴曲缬沙坦钠片、百特医疗的盐酸艾司洛尔氯化钠注射液；还有通过合作引进的复星医药的马来酸阿伐曲泊帕片、北海康城的马来酸奈拉替尼片。《通知》要求，公示期内如企业有异议，应在9月24日前进行申诉，无申诉且不进行价格调整的药品将于9月25日暂停挂网。湖南省推进药价治理工作十分迅速。今年7月，湖南省公布了第一批234个明显不符合湖南省价格管理要求的挂网药品。从价格纠偏的清单来看，主要针对同通用名、厂牌、剂型、规格药品的价格对比。这次公布的67个药品，价格全都高于参比制剂、过评品种最低挂网价。（健识局） 02 企业动态 丨齐鲁制药司美格鲁肽注射液申报上市 9月15日，中国国家药监局药品审评中心（CDE）网站最新公示，齐鲁制药申报的司美格鲁肽注射液的上市申请获得受理，具体适应症尚未披露。根据齐鲁制药开展的司美格鲁肽注射液的临床研究推测，此次申报的适应症可能为2型糖尿病。根据中国药物临床试验登记与信息公示平台官网，一项评估司美格鲁肽注射液（QLG2065）对比原研药物对于二甲双胍治疗后血糖控制不佳的2型糖尿病患者的有效性和安全性3期研究已经完成。(CDE) 丨默沙东、第一三共：HER3 ADC NSCLC III期研究成功 9月17日，Merck和第一三共宣布其ADC药物patritumab deruxtecan（HER3-DXd）已通过了3期HERTHENA-Lung 02研究。在今年的欧洲肿瘤内科学会（ESMO）会议结束几个月后，该药物因生产问题被美国FDA拒之门外。根据公布的结果，两家公司将与全球监管单位就该试验结果进行进一步的讨论。Patritumab deruxtecan是一款采用第一三共技术设计的潜在first-in-class靶向HER3的DXd ADC。目前为止，默沙东尚未公开无进展生存期（PFS）的具体情况，被视作评价疗效“金标准”的总生存期（OS）数据尚不成熟。此外，HER3 ADC的安全问题不能忽略，在这项临床试验中有两名受试者因间质性肺病（ILD）死亡。（健识局、药融圈） 丨迪哲医药公布舒沃替尼最新肺癌研究数据 9月17日，迪哲医药宣布，该公司首款自主研发的新型肺癌靶向药舒沃哲®（通用名：舒沃替尼片）国际多中心注册临床研究“悟空1B”（WU-KONG1 Part B、WU-KONG1B）最新全球亚组数据在2024欧洲肿瘤内科学会（ESMO）大会亮相。研究显示，舒沃替尼二、后线治疗EGFR 20号外显子插入突变非小细胞肺癌各亚组获益与全球整体人群一致。迪哲医药在其新闻稿中指出，该研究为该产品“高效低毒”和潜在“best-in-class”再添新证。舒沃替尼片是一款口服、不可逆、针对多种EGFR突变亚型的高选择性EGFR酪氨酸激酶抑制剂（TKI），首个适应症于2023年8月获NMPA通过优先审评在中国批准上市。（迪哲医药） 丨科伦药业地屈孕酮片获得药品注册批准 9月18日，科伦药业发布公告称，公司化学药品“地屈孕酮片”于近日获得国家药品监督管理局的药品注册批准。地屈孕酮片为雅培开发，目前已在100多个国家获批上市，用于治疗内源性孕酮不足引起的相关疾病，如痛经、子宫内膜异位症、孕激素缺乏所致先兆性流产或习惯性流产及辅助生殖技术中的黄体支持等。目前其已被中国《闭经诊断与治疗指南（2023 版）》、中国《子宫内膜异位症诊治指南（第三版）（2021）》、中国《孕激素维持妊娠与黄体支持临床实践指南（2021）》等国内外权威指南推荐广泛用于多种妇产科疾病。据相关数据统计，地屈孕酮片为国家医保乙类品种，2023年中国销售为20.5亿元。（科伦药业） 丨智康弘义高选择性ETA小分子拮抗剂SC0062获突破性治疗品种认定 9月18日，智康弘义宣布其核心管线之一的高选择性内皮素受体A（ETA）小分子拮抗剂SC0062胶囊通过CDE评审并完成相应公示程序，正式纳入突破性治疗品种名单，用于治疗伴有蛋白尿的IgA肾病，这是本项目研发进程中获得的又一项重大里程碑式成果。此次SC0062获得CDE授予突破性治疗品种的认定是基于一项名为2-SUCCEED的临床II期试验中IgA肾病队列的优异结果，临床数据显示SC0062与安慰剂组相比能够显著降低蛋白尿，且在不同剂量组间呈现出明确的量效关系，结果具有显著的临床意义和统计学意义。（智康弘义） 丨和黄医药第三代BTK抑制剂新药再获批临床 9月18日，CDE网站最新公示，和记黄埔医药的化学1类新药HMPL-760胶囊获批一项新的临床试验默示许可，适应症为联合R-GemOx（利妥昔单抗+吉西他滨+奥沙利铂）治疗复发/难治弥漫大B细胞淋巴瘤（R/R DLBCL）。公开资料显示，HMPL-760是一款第三代非共价BTK抑制剂，是和黄医药第十一个进入临床开发的潜在创新抗肿瘤候选药物。BTK是B细胞受体信号通路的关键组成部分，并在各种淋巴瘤的细胞增殖及存活中起重要调节作用。B细胞受体信号的异常激活与B细胞血液癌症的发生密切相关，B细胞血液癌症占所有非霍奇金淋巴瘤病例约85%。BTK是治疗某些血液癌症已确认的药物靶点，但BTK的C481S突变是一代和二代BTK抑制剂已知的耐药机制。（CDE、和黄医药） 丨上海医药1类创新药再获批临床 9月18日，CDE网站最新公示，上海医药申报的SPH4336片获得一项新的临床试验默示许可，拟定适应症为联合奥希替尼治疗KRAS突变型晚期实体瘤。公开资料显示，SPH4336为一款CDK4/6抑制剂，奥希替尼是一种不可逆的第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）。SPH4336是一种新型高选择性口服抑制剂，具有广谱的抗肿瘤作用。该产品对CDK4/6靶点具有较高的选择性，同时具有广谱抗Rb阳性肿瘤活性。根据中国药物临床试验登记与信息公示平台官网，该产品已经在中国开展了多项临床研究。该产品此前还获得美国FDA授予孤儿药资格，用于脂肪肉瘤适应症。其已经在美国开展了针对局部晚期或转移性脂肪肉瘤的2期临床试验。(CDE、上海医药） 丨罗氏玛巴洛沙韦流感暴露后预防III期研究成功 9月19日，罗氏宣布，抗病毒药物玛巴洛沙韦用于流感病毒的暴露后预防的III期CENTERSTONE研究取得了积极结果。该研究是第一项证明用于治疗呼吸道病毒性疾病的抗病毒药物具有减少病毒传播益处的全球性III期研究。CENTERSTONE(MV40618)是一项全球性、多中心、随机、双盲、安慰剂对照临床试验(n=4176)，评估了5-64岁流感感染者在症状出现后48h内服用单剂Xofluza或安慰剂对减少流感病毒在家庭接触者中进一步传播的疗效和安全性。结果显示，该研究达到了主要终点，即Xofluza可以有效降低流感病毒在家庭接触者中的进一步传播。(智通财经APP) 丨贝达药业：CFT8919胶囊获得药物临床试验批准通知书 9月19日，贝达药业发布公告称，今日，公司收到NMPA签发的《药物临床试验批准通知书》，公司从C4 Therapeutics，Inc.引进的CFT8919胶囊“拟用于携带表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者”的药物临床试验申请已获得NMPA批准。（贝达药业） *声明：本文不构成任何投资建议，仅出于传递更多信息之目的。 ------------------------------ 「长按」二维码添加小达「进群」 与更多行业伙伴共探市场前沿资讯 艾美达医药咨询 艾美达（北京）医药信息咨询有限公司，成立于2014年4月，是一家专业的医药行业咨询服务提供商。公司致力于将产业政策研究与真实世界的数据挖掘深度结合，洞悉行业政策对市场的影响，通过专业的研究提供前瞻性的市场分析，为企业产品上市后的市场准入提供整体解决方案。