Pharmaceuticals
Search documents
Sanofi flags delay in FDA's decision on tolebrutinib, shares fall
Reuters· 2025-12-15 08:49
Core Viewpoint - The U.S. Food and Drug Administration's decision on Sanofi's investigative drug for multiple sclerosis is expected to be delayed until the first quarter of 2026, moving from the previously communicated date of December 28 [1] Company Summary - Sanofi is a French pharmaceutical group that is currently awaiting a decision from the U.S. FDA regarding its drug for treating multiple sclerosis [1]
华东医药:全资子公司一审败诉,涉及金额为1.11亿元
Cai Jing Wang· 2025-12-15 07:52
近期送达的一审判决书表示,驳回杭州中美华东制药有限公司的全部诉讼请求。案件受理费598,732 元,由杭州中美华东制药有限公司负担。涉案的金额:111,386,405元(较首次披露暂计金额增加10,600 元) 近日,华东医药(000963)发布公告称,因侵害发明专利权纠纷,中美华东将青海珠峰冬虫夏草原料有 限公司、青海珠峰冬虫夏草药业有限公司、杭州华东武林大药房有限公司三名被告诉至浙江省高级人民 法院。 ...
兴齐眼药:取得换发《药品生产许可证》
Ge Long Hui· 2025-12-15 07:49
Core Viewpoint - The company, Xingqi Eye Medicine, has received a new Drug Production License from the Liaoning Provincial Drug Administration, which will replace its existing license expiring on December 22, 2025. The new license has reduced the scope of production for certain products [1]. Group 1 - The existing Drug Production License of the company will expire on December 22, 2025 [1] - The company has received a new Drug Production License from the Liaoning Provincial Drug Administration [1] - The new license has reduced the production scope to exclude "solution dosage forms (ophthalmic), inhalation preparations (workshop 101 production area 2 line), and large-volume injections" [1]
通化金马(000766) - 000766通化金马投资者关系管理信息20251212
2025-12-15 07:06
通化金马药业集团股份有限公司 投资者关系活动记录表 | | 专业队伍,打造创新营销模式,保证公司在新药销售的主 | | --- | --- | | | 导性、可控性,充分平衡药品的利润空间和患者可及性, | | | 做好新药上市的定价工作;结合市场的广泛需求,制定精 | | | 准营销策略。同时,现有生产体系已做好充分准备,设计 | | | 产能可满足阿尔茨海默病患者的用药需求,确保新药获批 | | | 后能够快速投入市场,为广大患者提供新的优质治疗选 | | | 择。 | | 关于本次活动是否涉 | 否 | | 及应披露重大信息的 | | | 说明 | | | 活动过程中所使用的 | 无 | | 演示文稿、提供的文 | | | 档等附件(如有,可 | | | 作为附件) | | | 投资者关系活动类别 | √特定对象调研 □分析师会议 | | --- | --- | | | □媒体采访 □业绩说明会 | | | □新闻发布会 □路演活动 | | | □现场参观 | | | □其他(请文字说明其他活动内容) 申万宏源证券:张静含、仰佳佳 | | | 建信基金:马牧青 | | | 上市公司: | | 活动参与人 ...
Sanofi Multiple Sclerosis Drug Hit by Double Setback
WSJ· 2025-12-15 06:56
A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of the disease didn't hit its main goal. ...
Press Release: Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis
Globenewswire· 2025-12-15 06:05
Core Insights - Sanofi's tolebrutinib did not meet its primary endpoint in the PERSEUS phase 3 study for primary progressive multiple sclerosis (PPMS), leading the company to decide against pursuing regulatory registration for this indication [1][8][10] Company Updates - Sanofi expressed disappointment over the study results but emphasized the importance of these findings in enhancing the understanding of multiple sclerosis biology [2] - The safety profile of tolebrutinib was consistent with previous studies, with drug-induced liver injury (DILI) identified as a risk, necessitating strict liver monitoring [2][4] - Tolebrutinib was provisionally approved in the UAE for non-relapsing secondary progressive multiple sclerosis and is under regulatory review in the EU and other regions [3] Financial Considerations - Sanofi will conduct an impairment test on the intangible asset value of tolebrutinib, with results expected in January 2026, but this will not impact the business net income or financial guidance for 2025 [4] Industry Context - Multiple sclerosis (MS) is characterized by progressive disability, with PPMS representing about 10% of the overall MS patient population [1][5] - There is a significant unmet need in addressing disability accumulation in MS, particularly for secondary progressive multiple sclerosis [6]
11 Most Profitable NYSE Stocks to Buy Right Now
Insider Monkey· 2025-12-15 04:41
In this article, we will look at the 11 Most Profitable NYSE Stocks to Buy Right Now.On December 12, Adam Parker, Trivariate Research founder and CEO, appeared on CNBC’s ‘Squawk on the Street’ to talk about his view on the ‘buy high and sell low’ mantra. He was of the view that valuation doesn’t work for picking stocks, as we have seen that we cannot buy super cheap stocks.Similarly, one can also not buy stocks that are down from 52 week highs because of underperformance. According to him, buy low, sell hig ...
Biogen: Alzheimer's Disease Treatment Needs More Real-World Data (NASDAQ:BIIB)
Seeking Alpha· 2025-12-15 03:22
Core Insights - Eisai's Leqembi has been highlighted for its potential to slow the progression of Alzheimer's disease, despite the CTAD conference yielding no major breakthroughs in treatment [1] Group 1: Alzheimer's Disease Research - The article emphasizes that Alzheimer's disease is primarily caused by oxidation and nitration, with many current treatments only addressing symptoms rather than the root causes [1] - Most Alzheimer's treatments focus on misfolded amyloid and tau proteins and neuroinflammation, but few target oxidative and nitrostative stress directly [1] - Natural products like panax ginseng and essential oils are suggested to have the potential to stabilize Alzheimer's disease by inhibiting oxidation and nitration [1]
华东医药股份有限公司关于全资子公司收到一审民事判决书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-12-14 23:51
Core Viewpoint - The company, through its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., is involved in a patent infringement lawsuit against three defendants, with the Zhejiang Provincial High Court recently issuing a ruling that dismissed all claims made by the company in the first instance [2][4]. Group 1: Lawsuit Details - The lawsuit pertains to a dispute over the infringement of invention patent rights, with the company claiming that the defendants used its patented fermentation process for Cordyceps sinensis without authorization [2][8]. - The total amount involved in the lawsuit is 111,386,405 yuan, which has increased by 10,600 yuan since the initial disclosure [2]. - The company plans to appeal the first-instance ruling to the Supreme People's Court of the People's Republic of China [2][8]. Group 2: Court Proceedings - The Zhejiang Provincial High Court accepted the case on December 25, 2023, and conducted two public hearings on April 8 and June 11, 2024 [3]. - The court's ruling rejected all claims made by the company, and the company is responsible for the litigation costs amounting to 598,732 yuan [4][5]. Group 3: Financial Impact - The ongoing lawsuit is not expected to have a significant impact on the company's current or future profits [7]. - The company has stated that it believes the court's findings and evidence used during the trial do not accurately reflect the actual circumstances of the case [7][8]. Group 4: Other Legal Matters - As of the announcement date, the company has no other significant undisclosed litigation or arbitration matters [6]. - There are minor ongoing legal matters that do not meet the threshold for significant disclosure, with a total amount involved of approximately 36,991.38 million yuan domestically and 2,539.5 million yuan internationally [6].
TLX DEADLINE ALERT: ROSEN, TRUSTED INVESTOR COUNSEL, Encourages Telix Pharmaceuticals Ltd. Investors to Secure Counsel Before Important Deadline in Securities Class Action First Filed by the Firm – TLX
Globenewswire· 2025-12-14 21:09
Core Viewpoint - Rosen Law Firm is reminding investors who purchased Telix Pharmaceuticals Ltd. securities between February 21, 2025, and August 28, 2025, about the January 9, 2026, deadline to become a lead plaintiff in a securities class action lawsuit [1]. Group 1: Class Action Details - Investors who purchased Telix securities during the specified Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties must move the Court by January 9, 2026, to serve as lead plaintiff, representing other class members [3]. - The lawsuit alleges that defendants made materially false and misleading statements regarding Telix's progress in prostate cancer therapeutic candidates and the quality of its supply chain and partners [5]. Group 2: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting its own achievements, including the largest securities class action settlement against a Chinese company [4]. - The firm has been ranked No. 1 for securities class action settlements in 2017 and has consistently ranked in the top 4 since 2013, recovering hundreds of millions of dollars for investors [4]. - In 2019, the firm secured over $438 million for investors, and its founding partner was recognized as a Titan of Plaintiffs' Bar by Law360 in 2020 [4].