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AstraZeneca's Fasenra Falls Short In Smoker's Lung Trial
Benzinga· 2025-09-17 17:20
AstraZeneca Plc AZN released on Wednesday topline data from RESOLUTE Phase 3 trial of Fasenra (benralizumab).AZN is showing upward bias. Get the complete picture here.Fasenra, despite showing numerical improvement, did not achieve statistical significance in the primary endpoint in patients with chronic obstructive pulmonary disease (COPD), also known as smoker’s lung disease.The safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the medicine.The company will a ...
LLY's $5B Virginia Plant Plan: Will U.S. Manufacturing Shift Pay Off?
ZACKS· 2025-09-17 16:26
Key Takeaways LLY plans a $5B Virginia facility for APIs and ADCs, creating 650 manufacturing jobs.This site is part of Lilly's $27B U.S. expansion, with four new plants planned by 2025.Trump's tariff threats prompt pharma giants like J&J, Roche and AstraZeneca to boost U.S. manufacturing.Eli Lilly and Company (LLY) announced plans to spend $5 billion to build a massive new manufacturing facility in Virginia as the Trump administration pushes companies to boost production in the United States.The new site i ...
ADARx Pharmaceuticals Appoints Industry Veteran, Laura Shawver, Ph.D., as Board Chair
Globenewswire· 2025-09-17 13:00
– Accomplished biopharma executive and entrepreneur brings a 25-year track record of upscaling valuable companies and realizing the potential of their innovations – SAN DIEGO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- ADARx Pharmaceuticals, Inc. (ADARx), a late-stage clinical biotechnology company developing next-generation RNA therapeutics, today announced the appointment of Laura Shawver, Ph.D., as Chair of its Board of Directors. “We are honored to welcome Dr. Shawver to our Board. Laura’s outstanding track r ...
Press Release: EADV: Sanofi's brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study
Globenewswire· 2025-09-17 05:00
Core Insights - Sanofi's brivekimig demonstrated positive results in the HS-OBTAIN phase 2a study for treating moderate-to-severe hidradenitis suppurativa (HS), showing clinically meaningful improvements in the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR50) [1][3][6] - The study indicated that brivekimig was well tolerated, with no serious adverse events reported [1][4] - The results will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris [1] Study Details - The HS-OBTAIN study was a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of brivekimig in biologic-naïve adults with moderate-to-severe HS [3][8] - Patients were randomized 2:1 to receive brivekimig 150 mg or placebo subcutaneously every two weeks for 16 weeks, followed by a 12-week open-label period and an 8-week safety follow-up [9] - The primary efficacy endpoint was the percentage of participants achieving HiSCR50 at week 16, with additional endpoints including HiSCR75, HiSCR90, and draining tunnel count [9] Efficacy Results - At week 16, 67% of patients in the brivekimig group achieved HiSCR50 compared to 37% in the placebo group, with a probability of superiority of 99.28% [7] - For HiSCR75, 54% of patients treated with brivekimig achieved this endpoint versus 22% with placebo [7] - HiSCR90 was achieved by 31% of patients in the brivekimig group compared to 9% in the placebo group [7] - The mean percent change from baseline in draining tunnel count was -56.0% for brivekimig versus +10.9% for placebo [7] Company Commitment - Sanofi emphasizes its commitment to addressing underlying inflammation in chronic inflammatory skin diseases through innovative treatments like brivekimig [5][6] - The company is exploring brivekimig's potential across a range of immune-mediated diseases [6][10]
2025年中国甘精胰岛素市场政策、产业链图谱、市场规模及发展趋势研判:原研企业赛诺菲品牌优势显著,但集采后面临国产替代压力较大[图]
Chan Ye Xin Xi Wang· 2025-09-17 01:37
内容概要:庞大的糖尿病患者群体带动我国胰岛素市场需求快速增长,甘精胰岛素是一种长效人胰岛素 类似物,具有长效、平稳的特点,能更好地模拟生理性基础胰岛素分泌,减少低血糖风险,在糖尿病治 疗中具有重要地位,其优势使得它在市场上具有较强的竞争力,据统计,2024年我国门甘精胰岛素行业 市场规模达60.83亿元,同比增长4.13%,占胰岛素行业整体规模的22.36%。 上市企业:甘李药业(603087)、通化东宝(600867)、联邦制药(03933.HK) 相关企业:宜昌东阳光长江药业股份有限公司、辽宁博鳌生物制药有限公司、赛诺菲(北京)制药有限 公司、江苏万邦生化医药集团有限责任公司、山东新时代药业有限公司、礼来苏州制药有限公司、合肥 天麦生物科技发展有限公司、复星万邦(江苏)医药集团有限公司 关键词:甘精胰岛素市场政策、甘精胰岛素产业链图谱、甘精胰岛素市场规模、甘精胰岛素竞争格局、 甘精胰岛素发展趋势 一、概述 甘精胰岛素(Insulin Glargine)是由大肠埃希菌通过重组DNA技术生产,主要作用是调节糖代谢,通过 促进骨骼肌和脂肪等外周组织摄取葡萄糖、抑制肝葡萄精产生而降低血糖,临床用于治疗糖尿病。 我 ...
CAC 40 Rises Sharply; Kering, Thales Among Strong Gainers
RTTNews· 2025-09-15 11:32
Despite Fitch Ratings lowering France's long-term credit rating, citing climbing debt and political instability, the French stock market is up in positive territory on Monday with investors looking ahead to the policy announcements from the Federal Reserve, the Bank of England and the Bank of Japan this week.The Fed is widely expected to lower interest rate by 25 basis points, while the BoE and BoJ are seen holding their rates steady.The benchmark CAC 40 was up 95.78 points or 1.23% at 7,921.02 a few minut ...
Altimmune Appoints Accomplished Commercial Executive Linda M. Richardson as Chief Commercial Officer
Globenewswire· 2025-09-15 11:30
GAITHERSBURG, Md., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced the appointment of Linda M. Richardson to the role of Chief Commercial Officer, effective September 16, 2025. Ms. Richardson joins the Company with more than 30 years of experience in sales and marketing, commercial, corporate and business development across a range of therapeut ...
Shareholder Alert: The Ademi Firm Continues to Investigate the Blueprint Medicines Corporation Transaction
Businesswire· 2025-09-15 05:10
Core Insights - The Ademi Firm is investigating Blueprint (Nasdaq: BPMC) regarding its transaction with Sanofi, focusing on potential insider benefits and conflicts of interest [1] Group 1 - Blueprint insiders received substantial benefits as part of change of control arrangements [1] - Certain insiders may have had conflicts of interest related to the transaction [1]
BMO Capital Maintains a Buy on Regeneron Pharmaceuticals (REGN), Sets a $640 PT
Yahoo Finance· 2025-09-14 05:17
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the best cheap stocks to buy for beginners. In a report released on September 8, Evan Seigerman from BMO Capital maintained a Buy rating on Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), setting a price target of $640.00. Why Regeneron Pharmaceuticals, Inc. (REGN) Crashed Last Week The analyst cited various factors supporting the optimistic outlook, including the promising results from its recent Phase 3 trials for the cat and birch allergy antibody ...
SNY's Gene Therapy Candidate for Eye Disease Gets FDA Fast Track Tag
ZACKS· 2025-09-11 17:46
Core Insights - Sanofi's investigational gene therapy SAR402663 received fast track designation from the FDA for treating neovascular (wet) age-related macular degeneration (AMD) [1][6] Group 1: Fast Track Designation Benefits - Fast track designation aims to expedite the development and review of drugs addressing serious conditions and unmet medical needs, allowing for earlier patient access [2] - The designation enables rolling review, allowing Sanofi to submit completed sections of the regulatory filing for SAR402663 as they become available, potentially speeding up the evaluation process [2][6] Group 2: Product Details - SAR402663 is a one-time intravitreal gene therapy targeting vascular endothelial growth factor (VEGF), which is responsible for abnormal blood vessel growth in the eye [5][6] - The therapy aims to reduce treatment burden by eliminating the need for frequent intravitreal injections [5][6] Group 3: Clinical Development - Sanofi is currently conducting a phase I/II study for SAR402663 in patients with neovascular/wet AMD, a severe condition affecting over a million people in the United States [7] Group 4: Competitive Landscape - Key competitors include AbbVie's ABBV-RGX-314, which is also a one-shot gene therapy targeting VEGF and is in pivotal studies for wet AMD, with data expected next year [8] - Another competitor is 4D Molecular Therapeutics' 4D-150, which is also targeting VEGF and is undergoing late-stage studies for wet AMD, with data anticipated in the second half of 2027 [9]