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The approval gives Novo Nordisk a chance to regain ground lost to rival Eli Lilly. https://t.co/JDbETIToaq ...

Core Insights - Johnson & Johnson (JNJ) has received FDA approval for the subcutaneous formulation of its EGFR/MET inhibitor, Rybrevant, now marketed as Rybrevant Faspro, which is approved for all indications of the intravenous version [1][8] Group 1: Product Approval and Advantages - Both Rybrevant and Rybrevant Faspro are approved in the U.S. for four indications related to EGFR-mutated non-small cell lung cancer (NSCLC), including two first-line and two second-line settings [2] - The subcutaneous formulation offers significant advantages in patient convenience, reducing administration time to about five minutes compared to several hours for the intravenous version [3][8] - The approval of Rybrevant Faspro is supported by data from the late-stage PALOMA-3 study, demonstrating its effectiveness compared to the IV formulation [5][8] Group 2: Competitive Landscape - With this approval, JNJ is better positioned to compete with AstraZeneca's Tagrisso, the current standard of care for EGFR-mutated NSCLC, although Tagrisso's oral administration remains a competitive advantage [4] Group 3: Oncology Sales and Growth Strategy - JNJ's oncology segment comprises approximately 27% of total revenues, with oncology sales rising nearly 21% year-over-year to $18.52 billion in the first nine months [10] - The company aims to achieve $50 billion in oncology sales by the end of the decade, having doubled its oncology sales from $10.7 billion in 2019 to $20.8 billion in 2024 [12] - JNJ is actively building its oncology pipeline through acquisitions, including a recent agreement to acquire Halda Therapeutics for $3.05 billion to enhance its prostate cancer portfolio [14]

Core Insights - AstraZeneca PLC and Daiichi Sankyo received FDA approval for Enhertu as a first-line treatment for HER2-positive breast cancer, in combination with Roche's Perjeta [2][7] - The approval is based on the DESTINY-Breast09 study, which showed a significant improvement in progression-free survival (PFS) [5][8] - AstraZeneca will pay Daiichi Sankyo a $150 million milestone payment following this approval [3][7] Regulatory Approval - Enhertu was reviewed under the FDA's real-time oncology review (RTOR) program [3] - The drug is already approved in over 85 countries for second-line treatment of HER2-positive breast cancer and for other cancers [3] Clinical Study Results - The DESTINY-Breast09 study demonstrated a median PFS of 40.7 months for the Enhertu-Perjeta combination, compared to 26.9 months for the standard regimen [5][8] - The combination reduced the risk of disease progression by 44% compared to the current standard treatment [5][7] Market Performance - Over the past year, AstraZeneca's shares increased by 36.3%, outperforming the industry average rise of 12.1% [4]

华润双鹤公告，公司全资子公司北京双鹤润创科技有限公司收到了国家药品监督管理局颁发的DC6001 片《药物临床试验批准通知书》。DC6001片拟用于青少年遗传性黄斑变性疾病(Stargardt病)。截至本公 告日，公司针对该药品累计研发投入为人民币1489.7万元(未经审计)。 ...

格隆汇12月23日丨博晖创新(300318.SZ)公布，控股子公司博晖生物制药（河北）有限公司（简称"河北 博晖"）研发的药品人凝血因子Ⅷ于近日收到国家药品监督管理局核准签发的《药品注册证书》，本品 对缺乏人凝血因子Ⅷ所致的凝血机能障碍具有纠正作用，主要用于防治血友病A和获得性凝血因子Ⅷ缺 乏而致的出血症状及这类病人的手术出血治疗。 ...

Core Viewpoint - Novo Nordisk's shares increased by 6% following the FDA's approval of its GLP-1 pill, marking a significant milestone as the world's first of its kind [1] Group 1: Product Approval and Market Position - The FDA's approval provides Novo Nordisk a competitive advantage over U.S. rival Eli Lilly in the GLP-1 market [1] - The GLP-1 pill will be available at a starting dose of 1.5 milligrams for $149 per month, accessible through pharmacies and select telehealth providers starting in early January [1] Group 2: Pricing Strategy and Consumer Access - Cash-paying patients can access the GLP-1 pill for the same price through TrumpRx, a direct-to-consumer website established by the Trump administration [2] - The pricing strategy aligns with the U.S. government's efforts to reduce consumer drug costs [2]

Novo Nordisk US listed shares jumping in late trading after it secured FDA approval for a pill version of its weight loss. Jab Wegovy. The pill is expected to launch in the US in January.Let's get more from Bloomberg's pharma reporter, Amber Tong. Amber. Walk us through the significance of this.We've had, of course, the injection for quite some time. Why is a pill so important. Yeah.Oliver, This is really something that many people have been waiting for for a long time. As you said, Wegovy and Novo Nordisk ...

Core Insights - Novo Nordisk's shares surged after receiving FDA approval for an oral version of its weight loss drug Wegovy, expected to launch in January [1][7] - The oral formulation of semaglutide, the active ingredient in both Wegovy and Ozempic, represents a significant advancement in the GLP-1 class of drugs, which are already multibillion-dollar products [2][3] - The approval of the oral pill addresses patient convenience, as it eliminates the need for injections, making it more appealing to those averse to needles [4][5] Company Context - Novo Nordisk has faced a challenging year, with shares down approximately 53% from earlier highs in February, highlighting the need for a successful product launch [6] - The approval of the oral obesity pill is seen as a potential growth driver, but the successful execution of its commercial rollout will be crucial [7] - Novo Nordisk is in a competitive landscape, with Eli Lilly, its main rival, also working on an obesity drug expected to receive approval soon, emphasizing the urgency for Novo Nordisk to establish its market presence [8][9] Industry Dynamics - The oral formulation of obesity drugs is a new frontier in the pharmaceutical industry, with increasing interest from both established companies and startups [9] - Novo Nordisk faces competition not only from Eli Lilly but also from compounding pharmacies and emerging companies that are exploring the obesity market [9]

Core Viewpoint - The article discusses the results of the "You Point, I Test" initiative organized by the Shaanxi Provincial Drug Administration, which aims to enhance public participation in drug safety supervision and ensure compliance with safety standards [2]. Group 1: Initiative Overview - The "You Point, I Test" activity was conducted to involve the public in drug safety regulation, leading to the selection of 9 batches of drug samples for testing based on public votes [2]. - All tested drug samples met the regulatory standards, and the results have been publicly announced [2]. Group 2: Testing Results - The following drugs were tested and found compliant: - Panlong Seven Tablets from Shaanxi Panlong Pharmaceutical Group [2] - Xiao Chai Hu Granules from Jiuzhaigou Natural Pharmaceutical Co., Ltd. [2] - Amoxicillin Capsules from Zhongshan Lienpu Pharmaceutical Co., Ltd. [2] - Multi-element Tablets from Heliang (Suzhou) Pharmaceutical Co., Ltd. [2] - Anti-viral Oral Liquid from Hangzhou China Resources Laotongjun Pharmaceutical Co., Ltd. [2] - Compound Calcium Gluconate Oral Solution from Harbin Pharmaceutical Group Sanjing Pharmaceutical Co., Ltd. [2] - Xiaoyao Pills (Concentrated Pills) from Lanzhou Foci Pharmaceutical Co., Ltd. [2]