Search Results for “ oncology” – Page 30 – media

Merck expects $20B+ in new cancer sales thanks to Daiichi ADC deal, Moderna vaccine

While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” Make no mistake, given Keytruda’s size, an overall business decline will likely still hit. But Merck is focused on making “the hill to dip as small as possible and the return to growth as fast as possible,” Davis said Monday at the 2024 annual J.P. Morgan Healthcare Conference. Davis and Merck Research Laboratories President Dean Li, M.D., Ph.D., pointed to the breadth of Merck’s portfolio across oncology, infectious disease, cardiometabolic, immunology and neuroscience to explain Merck’s potential for growth. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. 2028, it’s just another year, it’s just another point. We’re focused on 2030 to 2040.” At last year’s J.P. ...
- Source: drugdu
- 102
- January 11, 2024
J&J Joins the Cancer ADC Dealmaking Spree With $2B Ambrx Acquisition

Johnson & Johnson’s acquisition of antibody drug conjugate developer Ambrx Biopharma comes as Novartis and Merck also unveiled M&A deals on the first day of the J.P. Morgan Healthcare conference. In a report, the investment bank said big pharmas are looking for deals involving de-risked assets. By FRANK VINLUAN Big pharmaceutical companies splashed out big bucks in 2023 to acquire or license antibody drug conjugates, or ADCs. The trend is continuing into the new year with Johnson & Johnson reaching a $2 billion deal to acquire clinical-stage Ambrx Biopharma. According to deal terms announced Monday, J&J will pay $28 cash for each Ambrx share, which is a 105% premium to the biotech’s closing stock price on Friday. In other biopharma deal announcements, Merck is paying $680 million to acquire Harpoon Therapeutics, a developer of targeted cancer therapies, and Novartis is buying autoimmune disease drug developer Calypso Biotech for $250 ...
- Source: drugdu
- 137
- January 10, 2024
As cancer players jump head-first into ADC field, Novartis CEO explains how he’s resisted the temptation

San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. On Monday, the Swiss pharma’s CEO Vas Narasimhan explained how he’s resisted the temptation. The answer is radioligand therapies, Narasimhan said Monday during the 2024 J.P. Morgan Healthcare Conference in response to a question from Fierce Pharma. “We have a long history within research of ADCs, but we have not been successful,” Narasimhan said. “To be clear, part of our focus strategy is looking at places where we think we can create long-term sustainable leadership. And we are investing in radioligand therapies.” ADCs and radioligand therapies are similar in that both technologies act as guided missiles. For ADCs, the guiding force is an antibody, and the cancer-killing payload is a chemotherapy. A radioligand therapy uses a ligand to target cancer cells and kills them with a therapeutic radioisotope. Radiotherapies may have a safety ...
- Source: drugdu
- 90
- January 10, 2024
New Drug Application Accepted for Garsorasib (D-1553, KRAS G12C Inhibitor)

On December 29, 2023, China’s National Drug Administration (NMPA) has formally accepted the New Drug Application (NDA) for Garsorasib tablets (D-1553 tablets, KRAS G12C inhibitor) for the treatment of locally advanced or metastatic non-small-cell lung cancer with disease progression or intolerable disease after prior first-line systemic therapy, and with the presence of a KRAS G12C mutation confirmed by testing. metastatic non-small cell lung cancer. This NDA acceptance is primarily based on the results of a Phase II single-arm registrational clinical study (Study D1553-102, CDE Registry No. CTR20220745) conducted in China with Professor Lu Shun of Shanghai Chest Hospital as the principal investigator. Previously, the results of the Phase I clinical study of D-1553 in KRAS G12C mutation-positive non-small cell lung cancer were selected for an oral presentation at the World Conference on Lung Cancer (WCLC) in August 2022 and published in April 2023 in the Journal of Thoracic Oncology1 . ...
- Source: drugdu
- 175
- January 7, 2024
Hengrui’s Innovative Drugs Piratinib and Dalsili Breast Cancer Indications Both Recommended by 2024 CBCS Guidelines

Recently, the Chinese Breast Cancer Society Breast Cancer Diagnosis and Treatment Guidelines (2024 Edition) (hereinafter referred to as the CBCS Guidelines) has been updated and released. As one of the most important and authoritative Chinese diagnosis and treatment norms in the field of breast cancer, the CBCS Guidelines follow the international pace and cutting-edge progress, and comprehensively summarize and elaborate on breast cancer screening, examination, diagnosis and treatment, and reporting. In this guideline recommendation, two new indications for Hengrui Pharmaceuticals’ innovative drugs have been added, which are the first-line treatment regimen of piretinib combination for HER2-positive metastatic breast cancer, and the first- and second-line treatment regimen of dalsirib for HR-positive HER2-negative metastatic breast cancer (MBC). Thus, both innovative drugs have been recommended by the 2024 CBCS guidelines for the marketed breast cancer indications. Breast cancer has become the number one malignant tumor worldwide and is one of the most common ...
- Source: drugdu
- 182
- January 7, 2024
HANSIZHUANG Combined with Chemotherapy for the First-line Treatment of sqNSCLC

Shanghai, China, January 5th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was published in Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3. This publication serves as further evidence of the exceptional performance of HANSIZHUANG in the field of lung cancer. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital. Results of the overall population ASTRUM-004 were initially presented at the IASLC 2023 World Conference on Lung Cancer (WCLC 2023) in the form of oral presentation. Additionally, the data from its Asian subgroup were showcased in a poster session at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2023. Previously in 2022, the new drug application (NDA) of serplulimab for ...
- Source: drugdu
- 86
- January 7, 2024
百济神州PD-1抑制剂百泽安®（替雷利珠单抗）在中国获批第12项适应症,用于肝细胞癌一线治疗

中国北京、美国麻省剑桥和瑞士巴塞尔——2024年1月2日——百济神州（纳斯达克代码：BGNE；香港联交所代码：06160；上交所代码：688235）是一家全球性生物科技公司。公司今日宣布其PD-1抑制剂百泽安®（替雷利珠单抗）新适应症已获中国国家药品监督管理局（NMPA）批准，单药用于不可切除或转移性肝细胞癌（HCC）患者的一线治疗。肝癌是中国常见的高发恶性肿瘤。2020年中国肝癌新发病例约41万，约占全球总数的一半；死亡病例约39.1万，是中国第二大肿瘤致死病因1。70%-80%的肝癌患者在诊断时已经是中晚期2，失去了手术或其他局部治疗机会，临床预后较差，5年生存率仅为12.1%3，亟需更多治疗手段改善患者生存。百济神州高级副总裁、全球研发负责人汪来博士表示：“中国的HCC发病率近年来持续上升，存在较大的未被满足的临床需求。此次获批是替雷利珠单抗在肝癌领域的又一突破性进展，丰富了晚期HCC患者的一线治疗选择。我们期待这一全新的治疗方案能够惠及更多肝癌患者，进一步提升肝癌患者的生存获益。” 本次获批是基于RATIONALE 301（NCT03412773）的临床试验数据。该试验是一项随机、开放性的全球3期临床研究，从亚洲、欧洲和美国各研究中心共入组674例患者，旨在评估替雷利珠单抗对比索拉非尼作为不可切除的HCC成人患者一线治疗的效果。此前，RATIONALE 301试验结果以最新突破口头报告的形式，公布于2022年在法国巴黎举办的欧洲肿瘤内科学会（ESMO）大会，并于今年荣登肿瘤领域著名期刊《美国医学会杂志-肿瘤学》（JAMA Oncology）。研究结果显示：与索拉非尼相比，替雷利珠单抗展示出在总生存期（OS）上的非劣效性结果。替雷利珠单抗的中位OS为15.9个月，而索拉非尼的OS为14.1个月；替雷利珠单抗具有更高的客观缓解率（ORR）（14.3% vs 5.4%）和更持久的缓解（中位缓解持续时间DoR分别为36.1个月和 11.0个月）；替雷利珠单抗和索拉非尼治疗的安全性特征与既往研究一致。中国药科大学附属南京天印山医院消化系统肿瘤首席专家和RATIONALE 301 试验的全球牵头研究者（Leading PI）秦叔逵教授表示：“RATIONALE 301是一项由中国专家主导的、具有前瞻性的、随机对照、全球多中心3期注册临床试验。在设计和优化研究方案阶段，就兼顾东、西方肝癌的高度异质性，同时充分结合中国国情、病人特点和实践经验；试验过程中科学实施，严格质控，数据翔实，从而获得了预期的结果，为晚期肝细胞癌患者的一线免疫治疗提供了新的选择和可靠的依据。” 秦教授进一步表示，“替雷利珠单抗在本项试验中，单药一线治疗肝癌即展现出优良的有效性、安全性和耐受性，带来了明显的生存获益，具有重要的临床价值。可以相信此次替雷利珠单抗获批一线治疗晚期肝细胞癌适应症后，除了可以单药使用，还将推动含替雷利珠单抗联合方案的临床应用及研究进展，为众多的肝癌患者带来生的希望。” 至此，替雷利珠单抗已有12项适应症获得NMPA批准，是目前在中国获批适应症数量最多的PD-1抑制剂，其中11项适应症已全部纳入国家医保药品目录，也是纳入国家医保药品目录获批适应症数量最多的PD-1抑制剂。网址： https://www.beigene.com.cn/pressreleases/%e7%99%be%e6%b5%8e%e7%a5%9e%e5%b7%9epd-1%e6%8a%91%e5%88%b6%e5%89%82%e7%99%be%e6%b3%bd%e5%ae%89%ef%bc%88%e6%9b%bf%e9%9b%b7%e5%88%a9%e7%8f%a0%e5%8d%95%e6%8a%97%ef%bc%89%e5%9c%a8%e4%b8%ad%e5%9b%bd/
- Source: drugdu
- 177
- January 5, 2024
After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer

In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
- Source: drugdu
- 224
- January 4, 2024
A Monthly Summary of Hires and Layoffs

Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry. By KATIE ADAMS This roundup will be published monthly. It is meant to highlight some of healthcare’s recent hiring news and is not intended to be comprehensive. If you have news about an executive appointment, resignation or layoff that you would like to share for this roundup or the MedCity Moves podcast, please reach out to moves@medcitynews.com. Here is a selection of recent executive hires, promotions, departures and layoffs occurring across the healthcare industry. Hires Aledade, an independent primary care network focused on value-based care, brought Rosemary Weldon onto its team as its new chief product officer. She spent the last decade at CVS Health, where she most recently served as vice president of digital health product management. Amgen welcomed James Bradner to its C-suite, where he now serves as chief scientific officer and ...
- Source: drugdu
- 232
- January 3, 2024
Innovent Dosed First Participant in Phase 3 Clinical Study (GLORY-2) of Mazdutide (IBI362) Higher Dose 9 mg in Chinese Adults with Obesity

ROCKVILLE, U.S. and SUZHOU, China, Jan 2, 2024 — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed in a Phase 3 clinical trial (GLORY-2) of higher dose 9 mg mazdutide (Innovent R&D Code: IBI362) , a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with obesity. This is also the fourth large-scale phase 3 clinical study of mazdutide.GLORY-2 plans to enroll 450 subjects and randomize to receive mazdutide 9 mg treatment or placebo. The primary endpoints include the percentage change in body weight from baseline to week 60 and the proportion of subjects with 5% or more body weight loss from baseline at week 60.A Phase 2 study conducted in Chinese people with obesity ...
- Source: drugdu
- 158
- January 3, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.