Risankizumab-RZAA

-Continuity任命Josephine Torrente和Joseph DeSimone博士为董事会成员 佛罗里达州布雷登顿 2025年8月7日 /美通社/ -- 开创下一代组合产品药物递送的公司Continuity Biosciences，今日宣布任命两位极其杰出的领导者加入其董事会：Hyman, Phelps & McNamara, P.C.董事 Josephine M. Torrente ，以及连续创业者、斯坦福大学教授 Joseph M. DeSimone博士 。 这些任命标志着Continuity在推进变革性药物递送技术的进程中迈出了关键一步，并得到了世界一流监管专业能力和材料科学创新的有力支持。 Josephine M. Torrente 现任职务： 美国最大的FDA监管律师事务所Hyman, Phelps & McNamara, P.C.董事 经验： 30余年来，为制药及生物技术公司提供FDA监管战略、产品开发及生命周期管理咨询 战略贡献： Torrente女士在监管方面的深刻洞察将为Continuity的临床开发及FDA合作战略提供指导，助力其产品线扩展 Joseph M. DeSimone博士 现任职务： 斯坦福大学Sanjiv Sam Gambhir冠名转化医学与化学工程教授 荣誉和认可： 国家技术与创新奖章获得者；200余项专利发明人；350余篇科学论文作者；全美仅25位同时入选美国国家科学院、国家工程院和国家医学院三院院士的学者之一 创业领导力： Carbon（CLIP 3D打印开发者）联合创始人； Focal Medical （被Continuity收购）和 PinPrint （Continuity进行战略投资的3D微分配平台）创始人 战略贡献： DeSimone博士在材料科学、数字制造及药物递送方面的专业知识，与Continuity以本地化精准治疗为核心的平台战略高度契合 高管评论 “我们很荣幸欢迎Josephine和Joe加入我们的董事会，”Continuity Biosciences联合创始人兼执行主席 Bob Whitehead 表示。 “Josephine的监管敏锐度和清晰的判断力是首屈一指的。 Joe不仅在药物递送领域具有前瞻视野，还是我们通过Focal Medical和PinPrint开展合作过程中值得信赖的伙伴。 他们的专业知识将对我们持续扩大项目规模和建立长期价值起到关键作用。” Torrente和DeSimone加入Continuity现有董事会，该董事会包括两位Continuity联合创始人 Bob Whitehead 和 Ramakrishna Venugopalan （ 博士 、 工商管理硕士 ）、 Monica Reed （ 医学博士 ）、 Mike Fowler 及 Allen Weiss 。 Krishna Venugopalan 曾领导AbbVie的组合产品开发工作，为旗舰疗法 Skyrizi 及新近上市的 Vyalev 做出重要贡献——这两款均为高影响力的组合产品 Mike Fowler 是Berkshire Hathaway子公司Affordable Housing Partners, Inc.的首席执行官 Allen Weiss 曾担任迪士尼乐园及度假区（现为迪士尼乐园、体验与产品）全球运营总裁 Monica Reed 是UChicago Medicine AdventHealth的首席执行官，负责监督该卫生系统五大湖地区的战略发展与扩张，管理范围包括四家医院和超过50个医疗服务点 关于Continuity Biosciences<\/b><\/p> Continuity Biosciences成立于2024年，致力于开发面向生物制剂和复杂疗法的先进递送平台，重点关注 精准靶向<\/b>和 可调控释放<\/b>技术。 Continuity在休斯顿（德克萨斯州）、罗利（北卡罗来纳州）、布雷登顿（佛罗里达州）和都灵（意大利）开展业务，业务范围涵盖肿瘤学、代谢疾病、传染病和妇女健康。 通过包括Focal Medical在内的战略收购，以及对PinPrint等的针对性投资，Continuity正在打造一个差异化平台，以革新高难度疗法的递送方式。<\/p>

iStock, SergeyNivens From tariffs to drug pricing to the FDA, biopharma CEOs find themselves pulled into policy discussions on this year’s second quarter earnings calls. President Donald Trump has been re-raising many issues that pharmaceutical CEOs were happy to have left behind in the first quarter as earnings reporting season continues. Across the pharma landscape, CEOs are doing their best to project the idea that there is nothing to worry about as the pressure from Washington grows. Last week, the president sent a round of letters to a batch of pharma CEOs , asking them to get to work implementing Most Favored Nation drug pricing. Tariffs of 15% were placed on Europe , which could have implications on the industry, while the president threatened tariffs as high as 250% on imported pharmaceutical products specifically—although not any time soon. Then there was the high-profile resignation of an FDA official , which some reports say can be traced all the way back to the White House. Inevitably, these issues were raised as companies reported second quarter earnings over the past week. On the CEO Letters Pfizer CEO Albert Bourla couldn’t dodge the questions about those letters . Analyst after analyst tried to chip away at Bourla’s well-trained responses, seeking any inkling of how the high-pro leader is faring in discussions with the president. “I’m happy the way that they listen to us, in the way that we are trying collectively to find solutions that, from one hand, could make medicines affordable in the U.S., on the other hand, will make our industry even more competitive compared to China,” Bourla said. Bourla was one of very few pharma CEOs who was personally named by the president in the letters. While most were the same, Bourla’s had his full name scratched out and his first name written, apparently in Trump’s handwriting. This signaled to analysts that he had a close connection with the president, which traces back to Pfizer’s Operation Warp Speed effort to develop the COVID-19 vaccine during the pandemic. Bourla confirmed that he had spoken directly to Trump to discuss the matters in the letter. But who is Trump’s closest pharma pal? If you ask Regeneron CEO Leonard Schleifer, it isn’t him. Queried about the president’s personalization of the letters, Schleifer said he hasn’t been to Washington lately to discuss drug pricing or other issues. The Regeneron chief executive was asked if he, or any of his peers at Eli Lilly or Pfizer, might have some sway over policy these days. “I think the president probably knows Regeneron and my first name, given that it was Regeneron’s cocktail for COVID that may have saved his life,” Schleifer said. “Beyond that, I don’t have any great insights to the policies.” His counterparts at Lilly and Pfizer have been more active in attempting to influence policy at this time, Schleifer added. Bourla confirmed as much in his earnings comments days later, while Lilly has yet to report. On the specifics of the drug pricing plan, Schleifer said he agrees with the president that European nations are not paying their fair share for drugs. He said to change this “complicated” reality, policy and trade need to be adjusted, because companies can’t do it alone. “American consumers should not be paying for all of the innovation. The solution is simply not to lower prices in the U.S. without some equilibrating in Europe because then there’ll be no innovation,” Schleifer said. AstraZeneca’s Pascal Soriot agreed, saying that his company has been lobbying the Trump administration and offering some policy proposals that could achieve what the president is trying to do. But he also noted that access to new medications needs to be considered as the pricing discussion continues. “In many countries in Europe, patients wait for years to get access to medicines that could save their lives,” Soriot said on AstraZeneca’s earnings call last week. AbbVie’s Robert Michael, meanwhile, credited the president’s One Big Beautiful Bill Act with expanding the orphan drug exemption to the benefit of cancer therapy Venclexta. Michael said the company had assumed that drug would be subject to price negotiations soon under the Inflation Reduction Act, but with the change in the newer bill, Venclexta is not expected to be subject. “That’s an example of a good policy change where innovation is being rewarded and not penalized,” Michael said during AbbVie’s call last week. On FDA Disruption If anyone has insight into the inner workings of the FDA drug approval machine right now, it’s Moderna’s regulatory team. On a Friday earnings call , President Stephen Hoge said the company was pleased with the three approvals they received in the past quarter. “I will note that they happened on time, and that was through the incredibly diligent work of the folks at FDA to conduct those reviews in a rigorous way, and we continue to feel that those productive dialogues are going on now even on our existing files for the seasonal update,” he said. Hoge pledged to work closely with the FDA to transparently respond to any questions, even after the much-publicized changes within the Center for Biologics Evaluation and Research (CBER), and the CDC, including at the agency’s Advisory Committee on Immunization Practices . When any questions are received by the agencies to help inform public health, Hoge said that Moderna will make sure to provide that information. On Tariffs Many CEOs—of Vertex Pharmaceuticals, Moderna, Takeda, Regeneron and many more—brushed off the threat of tariffs to the pharmaceutical industry, especially for near term impacts this year. There’s still too much uncertainty on what exactly will be taxed, so the executives weren’t willing to speculate. But AbbVie’s Michael went a bit further, noting that one of his company’s largest products, Skyrizi, is made in the U.S. for the domestic market. Longer term, AbbVie plans to add even more U.S. manufacturing capacity, as part of a $10 billion capital investment announced on last quarter’s earnings call. This would include four sites for active pharmaceutical ingredients, peptide dug products and devices. Otherwise, Michael, like his fellow CEOs, will wait for the Section 232 process to complete before commenting further on how tariffs will impact AbbVie. Merck’s Robert Davis took a shot at providing some clarity to analysts about what a 15% tariff would be like for the Keytruda-maker. While he wouldn’t give specific guidance, he said that if 15% tariffs were implemented today, the impact would be minimal as Merck has conducted inventory management and moved manufacturing to the U.S. already. Similarly, AstraZeneca CFO Aradhana Sarin explained that since the first quarter, the company has been managing the potential tariff impact through inventory. AstraZeneca is also starting tech transfers for some products that are not currently manufactured in the U.S. Still, Sarin expects little impact. For its part, Pfizer included potential impacts of Most Favored Nation drug price changes and tariffs in its guidance this quarter—specifically factoring in the currently implemented tariffs on Canada, China and Mexico—but declined to provide actual numbers, to the chagrin of analysts on the call. Bourla, like his fellow pharma execs, said that Pfizer will await the conclusion of the Section 232 investigation before elaborating on tariffs’ impact to the company, though he did note that Pfizer is talking with trade officials about tariffs.