Core Viewpoint - Hims & Hers has decided to withdraw its copycat weight-loss pill from the market following controversy and potential legal threats from pharmaceutical giant Novo Nordisk and the FDA [1][2][4] Group 1: Company Actions - Hims & Hers announced the cessation of its compounded semaglutide pill after engaging in discussions with industry stakeholders [2] - The company had initially aimed to offer a cheaper version of Novo Nordisk's Wegovy weight-loss pill, priced at $49 for the first month, compared to Novo's price of approximately $100 more [2] - Hims & Hers maintains its commitment to providing safe and affordable care to millions of Americans [2] Group 2: Legal and Regulatory Context - Novo Nordisk threatened legal action against Hims & Hers, accusing the company of "illegal mass compounding" and deceptive advertising practices regarding GLP-1 products [3] - The FDA announced plans to take legal action against Hims & Hers, which includes restricting access to the ingredients used in the pill and referring the matter to the Department of Justice [4] Group 3: Marketing and Public Relations - Hims & Hers' announcement raises questions about its planned advertisement during Super Bowl 60, which features rapper Common discussing the health gap in America [4] - The company previously indicated that the advertisement is expected to provoke strong reactions [4]

Core Insights - Roche's experimental drug fenebrutinib has successfully met its primary endpoint in a late-stage trial for patients with primary progressive multiple sclerosis [1] Company Summary - Roche is a Swiss pharmaceutical company that is advancing its research in multiple sclerosis treatments [1] - The successful trial results for fenebrutinib may enhance Roche's position in the competitive pharmaceutical market for neurological disorders [1] Industry Summary - The pharmaceutical industry is witnessing significant advancements in treatments for multiple sclerosis, particularly in progressive forms of the disease [1] - The success of fenebrutinib could lead to increased investment and interest in the development of similar therapies within the industry [1]

Core Viewpoint - Hims & Hers will cease offering the compounded semaglutide pill following FDA's announcement of potential action against the company regarding its $49 weight-loss pill [1] Company Summary - Hims & Hers is a telehealth provider that has been involved in offering a compounded version of semaglutide for weight loss [1] - The decision to stop offering the pill comes in response to regulatory scrutiny from the U.S. Food and Drug Administration [1]

Core Viewpoint - Hims & Hers (NYSE:HIMS) shares are experiencing a significant decline of 16% in after-hours trading due to coordinated actions by two federal agencies targeting its compounded weight-loss drugs [1] Company Summary - Hims & Hers is facing regulatory scrutiny as two federal agencies have taken coordinated actions against its compounded weight-loss drugs, leading to a sharp drop in its stock price [1]

Health Regulators Ask DOJ to Investigate Hims & Hers. The Stock Plunges. - Barron'sSkip to Main ContentThis copy is for your personal, non-commercial use only. Distribution and use of this material are governed by our Subscriber Agreement and by copyright law. For non-personal use or to order multiple copies, please contact Dow Jones Reprints at 1-800-843-0008 or visit www.djreprints.com.# Health Regulators Ask DOJ to Investigate Hims & Hers. The Stock Plunges.By [Evie Liu]ShareResize---ReprintsIn this arti ...

来源：智通财经网 美国食品药品监督管理局(FDA)表示，将打击类似Hims & Hers Health(HIMS.US)所销售的仿制减肥药。 就在此前一天，这家远程医疗公司开始提供一种价格大幅打折的仿制药品。 远程医疗公司通过调整剂量或添加成分来规避规则，使他们的产品被认为与品牌版本有所区别。 在一项更明确的行动中，美国卫生与公众服务部(HHS)总法律顾问迈克·斯图尔特周五在 X 上发帖称， 该机构已根据《联邦食品、药品和化妆品法案》中的犯罪及刑事诉讼条款，将 Hims 移交给司法部进行 调查。 诺和诺德发言人利兹·斯克尔布科娃在声明中表示："我们欢迎 HHS 和 FDA 今天采取的行动，以保护患 者免受未经批准的仿制药侵害，这些药物是由外国不真实的活性药物成分制成的，可能对患者安全构成 重大风险。" Hims 的代表表示，公司一直按照适用法律运营，并"期待继续与 FDA 接触，以确保人们能够安全地获 得负担得起的医疗服务"。 礼来在声明中对这一举措表示赞赏，称公司期待 FDA、其他监管机构和执法部门采取行动。 诺和诺德与 Hims 之间有一段波折的历史。去年，两家公司曾合作提供诺和诺德注射减肥药的折扣版 本 ...

Core Viewpoint - Hims & Hers Health Inc's stock plummeted 12.6% after the FDA issued a warning regarding the sale of unapproved compounded GLP-1 drugs, indicating a significant regulatory challenge for the company [1]. Regulatory Actions - The FDA is taking decisive actions against companies like Hims & Hers that sell compounded drugs as alternatives to approved treatments, aiming to protect consumers from unverified products [3]. - The FDA's intervention follows Hims & Hers' aggressive expansion, including the launch of a compounded semaglutide tablet priced at $49 per month, which the company claims is designed to enhance absorption [3]. - The FDA has warned that companies cannot claim unapproved compounded products are equivalent to FDA-approved drugs, indicating a tightening of regulations [3]. Competitive Landscape - Novo Nordisk, the manufacturer of the popular drug Wegovy, has responded by labeling Hims & Hers' new product as "unapproved, misleading, and untested," and plans to take legal and regulatory action against the company for "illegal mass compounding" [3]. - Novo Nordisk emphasizes that it remains the only manufacturer producing a legally approved oral semaglutide tablet using proprietary absorption technology [3]. Company Positioning - Hims & Hers executives argue that their platform provides essential accessibility and personalized services for patients who prefer non-injection methods [4]. - The company claims to have invested years in building the necessary infrastructure to offer personalized options to patients [4]. - The FDA's recent stance indicates an escalation in actions against misleading direct-to-consumer advertising, following previous warnings about unverified claims regarding compounded drugs [4]. Market Implications - The regulatory crackdown creates a volatile environment for telehealth investors, as Hims & Hers faces significant survival threats since its inception [5]. - The market is closely monitoring whether the FDA will follow through on its threats of legal action without prior notice, which could impact Hims & Hers' promised affordability [5].

Core Viewpoint - The FDA is taking decisive steps to restrict the use of GLP-1 active pharmaceutical ingredients in non-approved drugs [1] Group 1 - The FDA's actions indicate a regulatory tightening around GLP-1 drugs, which may impact companies involved in the development and marketing of these pharmaceuticals [1]

The U.S. Food and Drug Administration said on Friday it plans to restrict GLP-1 ingredients used in non-approved compounded drugs that companies such as Hims & Hers and other compounding pharmacies ha... ...

Hims & Hers also said it's selling a cancer-detection test that's featured in its Super Bowl ad, which plays like a commentary on the wealthy's access to better healthcare. ...