Ralinepag

❈ ❈ ❈ ❈ ” ☆CDE受理(3月3日) ☆ ☆待领取批准证明文件☆ (3月3日) 国内新闻 ❀ 礼来宣布，IL-13单抗 [ 来瑞奇珠单抗（Lebrikizumab，英文商品名：Ebglyss）]在国内申报上市，适用于治疗患有中度至重度特应性皮炎（AD）的12岁及以上青少年和成人患者。 ❀ 亚虹医药宣布，[ 盐酸氨酮戊酸己酯软膏宫颈光动力治疗系统 ]在国内获批上市，拟用于治疗18 岁及以上排除原位癌的经组织学证实的宫颈高级别鳞状上皮内病变的患者。该产品由盐酸氨酮戊酸己酯软膏和一次性使用宫颈光动力治疗灯组成。 国际新闻 ❀ Priovant Therapeutics宣布，美国FDA已受理在研小分子选择性TYK2和JAK1双重抑制剂 [ Brepocitinib]新药申请并授予优先审评资格，用于治疗皮肌炎（DM）的患者。 ❀ United Therapeutics宣布，前列环素受体激动剂 [ Ralinepag ] 3期临床研究达到主要终点。研究结果显示：在肺动脉高压（PAH）患者中，与安慰剂相比，ralinepag可将临床恶化事件风险降低55%（HR=0.45，95% CI：0.33-0.62，p<0.0001）。在该研究中，ralinepag在延缓疾病进展方面展现出持久疗效。除主要终点外，ralinepag在多项关键次要终点上亦优于安慰剂，包括6分钟步行距离（6MWD）和N末端B型利钠肽前体（NT-proBNP）的变化；在第28周时，ralinepag使患者实现临床改善的概率较基线提高47%（p=0.015）。 授权许可/期刊发布/收购 ❀ 中国生物制药宣布附属公司正大天晴药业已与赛诺菲就JAK/ROCK抑制剂罗伐昔替尼在全球的开发、生产及商业化订立独家授权协议。根据协议条款，赛诺菲将从正大天晴获得在全球范围内开发、生产及商业化罗伐昔替尼的独家许可。中国生物制药则有权获得最高 15.3 亿美元的付款，其中包括 1.35 亿美元的首付款以及潜在开发、监管及销售里程碑付款，另外还将获得基于罗伐昔替尼年度净销售额的最高双位数的阶梯式特许权使用费。罗伐昔替尼片是正大天晴自主研发的一款首创新药（first-in-class），具有全新化学结构。作为一类新型、口服的 JAK/ROCK 抑制剂，罗伐昔替尼能够抑制 JAK 家族激酶活性及 ROCK 激酶活性，抑制 JAK/STAT 通路的持续异常活化，同时抑制 ROCK2 减轻 STAT3 的磷酸化，进而重建免疫平衡。

Today, a brief rundown of news from the Food and Drug Administration and Intellia Therapeutics, as well as updates from United Therapeutics, the Department of Health and Human Services and Merck & Co. that you may have missed.The Food and Drug Administration issued 30 warning letters to telehealth companies for making false or misleading claims about GLP-1 products offered on their websites. The new batch of letters is the second round the agency has sent since September, and warns companies making claims of sameness with FDA-approved medicines while obscuring product sourcing. The announcement comes amid a broader crackdown on pharmaceutical ads by the agency and a recent step-up in threats against GLP-1 copycats after Hims & Hers short-lived attempt to launch a compounded version of Novo Nordisks Wegovy pill.U.S. regulators on Monday also cleared Intellia Therapeutics to resume a Phase 3 trial evaluating one of its experimental gene editing treatments against transthyretin amyloidosis with cardiomyopathy, a progressive heart condition. The study is one of two late-stage trials that were paused last year following the death of a participant. Both have now been cleared to restart with new safeguards and, in the latest case, updating the study protocol to exclude patients with a recent history of certain heart problems.Intellia shares initially climbed by more than 10% before falling back.A pulmonary arterial hypertension drug from United Therapeutics lowered the risk of patients disease worsening by 55% compared to a placebo in a Phase 3 trial, positioning the company to seek approval later this year. The drug, ralinepag, is a newer type of prostacyclin receptor agonist, a therapy designed to help widen blood vessels in people with the condition. The results exceeded expectations and compare favorably with what was observed in testing of another prostacyclin therapy, Johnson & Johnsons Uptravi, wrote Leerink Partners Roanna Ruiz. United acquired ralinepag via a 2018 icensing deal with Arena Pharmaceuticals.Health and Human Services Secretary Robert F. Kennedy Jr. appointed two new members to the key federal panel, ACIP, that guides U.S. vaccine policy. One new appointee is Sean Downing, a Florida-licensed primary care physician who works in concierge medicine. The other is Angelina Farrella, a pediatrician and owner of a medical practice in Webster, Texas. The two have joined a committee thats been overhauled over the last year and since weakened multiple longstanding vaccine recommendations, drawing criticism from major medical organizations as well as, recently, a lawsuit from 15 Democrat-led states. The panels next meeting is scheduled for March 18.Merck & Co. on Saturday detailed a pair of study results that could help broaden the use of its kidney cancer drug Welireg. In one study, adding Welireg to Mercks immunotherapy Keytruda after surgery to remove a tumor reduced the risk of disease progression or death by 28% when compared to Keytruda alone. In the other, Welireg and Eisais Lenvima cut that same risk by 30% versus Exelixis Cabometyx in people who relapsed after treatment with Keytruda. The results, which Merck first announced without specifics last year, position the Welireg regimens to rapidly become standard-of-care treatments in their respective settings, wrote Leerinks Daina Graybosch. The Leerink team is predicting more than $3.4 billion in U.S. peak sales for Welireg, which Merck acquired in a 2019 buyout. '