FDA's vac cine ad comm unan i mous ly sup ports Mod er na's boost er in same pop u la tions as Pfiz er's boost er

FDA的vac电影广告通信unan i mous ly sup port Mod er na的boost er与Pfiz er的boost er在相同的pop u la

2021-10-15 05:30:07 ENDPOINTS NEWS


The FDA’s vac­cine ad­vi­so­ry com­mit­tee on Thurs­day vot­ed 19-0 in sup­port of ex­pand­ing Mod­er­na’s Covid-19 vac­cine EUA for boost­er dos­es for cer­tain high-risk in­di­vid­u­als. FDA is ex­pect­ed to au­tho­rize the Mod­er­na boost­er short­ly. Sim­i­lar­ly to the Pfiz­er boost­er shot, Mod­er­na’s will like­ly be au­tho­rized for those old­er than 65, adults at high risk of se­vere Covid-19, and adults whose fre­quent in­sti­tu­tion­al or oc­cu­pa­tion­al ex­po­sure to SARS-CoV-2 puts them at high risk of se­ri­ous com­pli­ca­tions of Covid-19. But un­like the Pfiz­er ad­comm, where FDA had to scram­ble to get the com­mit­tee to vote in fa­vor of a boost­er, this com­mit­tee was unan­i­mous with the Mod­er­na shot. Is­raeli sci­en­tists once again pre­sent­ed the lat­est in their ex­pe­ri­ence with boost­ers, which showed re­duced Covid-19 cas­es. Sev­er­al pan­elists praised how com­pelling the Is­raeli da­ta pre­sent­ed were. Paul Of­fit, a VRB­PAC pan­elist and pro­fes­sor of pe­di­atrics at Chil­dren’s Hos­pi­tal of Philadel­phia, called the da­ta clear for 70- to 79-year-olds, but said he was less im­pressed with the da­ta for those who are younger. Oth­ers al­so ques­tioned the da­ta be­hind the boost­er, par­tic­u­lar­ly as for Mod­er­na is ap­ply­ing to ad­min­is­ter a half-dose of what was pro­vid­ed in the pri­ma­ry, two-shot se­ries. “The da­ta we have is on­ly lim­it­ed to about 149 pa­tients on Mod­er­na. So I have some hes­i­ta­tion,” VRB­PAC mem­ber Jean­nette Lee, a pro­fes­sor of bio­sta­tis­tics at the Uni­ver­si­ty of Arkansas for Med­ical Sci­ences, said. Pan­elist Er­ic Ru­bin, ed­i­tor in chief of the New Eng­land Jour­nal of Med­i­cine and an ex­pert on in­fec­tious dis­eases at Har­vard’s pub­lic health school, not­ed “the da­ta are not per­fect,” but these are “ex­tra­or­di­nary times.” He al­so re­it­er­at­ed the idea that the over­all ef­fect of a boost­er is much less than pri­ma­ry vac­cines, both here and abroad. “We need to vac­ci­nate the un­vac­ci­nat­ed,” Ru­bin said. Oth­er mem­bers of the com­mit­tee ex­plained how the Mod­er­na boost­er needs to win EUA as it wouldn’t make sense as a prac­ti­cal mat­ter to have a Pfiz­er boost­er and not one for Mod­er­na. FDA’s top vac­cine leader Pe­ter Marks of­fered a sim­i­lar sen­ti­ment in not­ing that the CDC’s com­mit­tee, which is like­ly next up to re­view the Mod­er­na boost­er, may de­cide to fur­ther ma­nip­u­late the rec­om­men­da­tions from VRB­PAC, “but to the ex­tent that we can come to place that’ll be ac­cept­able for ACIP, that’ll be ap­pre­ci­at­ed.” VRB­PAC pan­elist Steven Pergam, an ex­pert on in­fec­tious dis­eases at the Fred Hutchin­son Can­cer Re­search Cen­ter in Seat­tle, said he is “very sup­port­ive” of those with oc­cu­pa­tion­al Covid-19 risks re­ceiv­ing the boost­er, par­tic­u­lar­ly as the US seeks to pro­tect health in­sti­tu­tions from out­breaks. For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel. The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks. RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.   Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee. A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news. With about $10 billion in taxpayer funds invested in Moderna so far, it would seem that the company would be more understanding of pleas from President Joe Biden and the federal government to provide more vaccine doses to low- and middle-income countries. But the Biden-Moderna feud over supplying the world with doses of mRNA vaccines is now spilling into the public, with Biden’s chief science officer of the government’s Covid-19 response David Kessler explaining the details in an online panel discussion moderated by Yale law professor Amy Kapczynski on Wednesday. While both Pfizer/BioNTech and Moderna are looking to administer boosters for their Covid-19 vaccines six months after the initial two-dose series, J&J — which has vaccinated about 15 million Americans so far with its one-shot vaccine — is taking a more unique approach with boosters. According to briefing documents released ahead of Friday’s FDA adcomm on the booster dose, J&J is calling for its boosters to be administered anywhere from two months to six months following the initial shot, depending on the strength of the immune responses. About five years ago, Amit Etkin had a breakthrough. The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain. A year and a half after Chinese officials ordered BeiGene to stop selling Bristol Myers Squibb’s Abraxane in the wake of an alarming inspection of a US facility, the manufacturing issues at the root of the import suspension still appear unresolved. And Bristol Myers wants to axe the Abraxane supply deal altogether. But BeiGene, which is currently in arbitration proceedings against its Big Pharma partner, won’t let it off the hook so easily. Nearly a year after being granted an EUA, Regeneron and Roche’s Covid-19 antibody cocktail will now go before the FDA for a chance at full approval. The big biotech announced Thursday it has submitted a BLA for the drug, shooting for an OK to treat Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals. Regulators granted priority review, setting April 13, 2022 as the PDUFA date, and Regeneron said the agency is preparing an adcomm before then. As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans? The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.
周四,美国食品和药物管理局的VAC电影广告以19-0的比分在国防部的新冠肺炎VAC电影EUA中获得了更高的风险。美国食品和药物管理局倾向于短期改善这种模式。 对于那些65岁以上的老年人,那些患新冠肺炎的高风险成年人,以及那些在新型冠状病毒的自由或自由使他们处于新冠肺炎高风险的成年人来说,这是一个更好的机会。但与PFIZ的广告不同,在PFIZ的广告中,美国食品和药物管理局不得不仓促行事,让committee投票给一个促进者,这个committee与moderna镜头不符。 Raeli Scientis又一次预先发送了他们最晚的信息,显示了新冠肺炎的信息。Severalpanelists称赞了预先发送的信息是多么的简洁。 FIT的保罗是一名VRB PAC泛专家,也是费城Children's Hospi'tal of Philadelphia的体育专家,他称DaTa对70岁至79岁的人来说是明确的,但他说他对年轻人来说DaTa不太感兴趣。 至于moderna是previd的一半,是previd的一半,是两次射击的一半。 “我们的da-ta在moderna上大约有149个pa。所以我有一些他的想法,“阿肯色州医学院生物学专家让·内特·李说。 潘埃利斯特·鲁宾,新医学院的首席执行官和哈尔瓦尔酒吧卫生学校的首席执行官,不是“da-ta不是per-fect”,但这些是“ex-tra或di-di时代”他非常重视这样一个想法,即无论是在这里还是在国外,经济增长的总体效果都比经济增长要少得多。 鲁宾说:“我们需要把联合国变得更糟。” COMmit-tee的成员们讲述了mod-na boost er需要如何赢得EUA,因为作为一个pfiz boost er和mod-na boost er是没有意义的。 美国食品和药物管理局的顶级VAC电影领导人表示,疾病预防控制中心的committee可能会从VRB pac获得更多的信息,“但对于我们能够为ACIP提供信息的ext来说,这将是AP pre-ci。” vrb pac panelist Steven Pergam是弗莱德·哈钦(Fred Hutchin)Son can recear center,他说他“非常支持”那些新冠肺炎有风险的人,因为美国寻求从休息中恢复健康。 要了解新闻冠状病毒的所有终点,请查看我们的社交新闻频道。 由于负面情绪占据主导地位,生物技术板块已从2月份的高点稳步回落。新冠肺炎疫苗的成功大大增强了该行业的乐观情绪,使投资者敏锐地意识到生物制药研发引擎的潜力。但从今年年初开始,临床试验、监管和准入方面的挫折提醒投资者该行业固有的风险。 加拿大皇家银行资本市场(RBC Capital Markets)最近对投资者进行了调查,以了解市场的温度,这是专家/通才和只做多/多空投资策略的混合。进入下半年,投资者大多认为该行业被低估(49%),与上半年只有20%的人认为该行业被低估相比有了很大变化。大约41%的投资者现在认为,生物技术将在2021年下半年表现低于标准普尔500。尽管有这种观点,54%的人计划维持市场头寸,41%的人仍计划增持。 本周早些时候,我们播出了第四届欧洲生物制药年度峰会,顶级高管阵容强大。我安排的一对一对话之一是与阿斯利康肿瘤研究主管苏珊·加尔布雷斯的对话。在一次广泛的讨论中,加尔布雷斯回顾了癌症药物管道和影响制药巨头开发工作的关键趋势。您可以观看上面的视频,或者坚持下面的脚本。-JC 乔·拜登总统可能会选择奥巴马总统手下的前美国食品和药物管理局局长罗布·卡利夫(Rob Califf)作为下一任美国食品和药物管理局局长提名人,这是美国食品和药物管理局在没有永久领导人的一段有争议的长时期的结束。 卡利夫是前杜克大学心脏病学家和著名的国家医学科学院的成员,他将是一家努力应对CBER和CDER高调退休的机构的受欢迎的面孔。他还将回到他在奥巴马总统任期结束时很舒服的一个角色。《华盛顿邮报》首先报道了这一消息。 到目前为止,约有100亿美元的纳税人资金投资于莫德纳,该公司似乎会更理解乔·拜登总统和联邦政府向中低收入国家提供更多疫苗剂量的请求。 但拜登和莫德纳在向世界提供基因疫苗剂量方面的不和现在正在蔓延到公众,拜登政府新冠肺炎回应的首席科学官大卫·凯斯勒(David Kessler)周三在耶鲁大学法学教授艾米·卡普钦斯基(Amy Kapczynski)主持的在线小组讨论中解释了细节。 虽然辉瑞/生物技术公司(Pfizer/BioNTech)和莫德纳(Moderna)都希望在最初的两剂疫苗系列六个月后为他们的新冠肺炎疫苗注射助推器,但J&J--迄今为止已为约1500万美国人接种了一针疫苗--正在对助推器采取更独特的方法。 根据周五美国食品和药物管理局关于加强剂量的adcomm之前发布的简报文件,J&J呼吁根据免疫反应的强度,在首次注射后两个月至六个月内给药。 大约五年前,阿米特·埃特金有了突破。 这位斯坦福大学的神经学家,一位说话温和的半神童,在还是住院医生的时候就成为了教授,十年来一直痴迷于如何更好地定义精神疾病。治疗抑郁症或双相情感障碍的药物对许多患有这种疾病的患者不起作用,他怀疑原因是传统诊断实际上没有触及患者大脑的核心。 在对美国一家工厂进行令人震惊的检查后,中国官员下令北根停止销售百时美施贵宝的Abraxane一年半后,导致进口暂停的制造问题似乎仍未解决。 布里斯托尔迈尔斯公司希望完全砍掉亚伯拉罕的供应交易。 但目前正在对其大型制药合作伙伴进行仲裁的贝根不会这么容易就让它脱身。 在获得EUA近一年后,雷根龙和罗氏的新冠肺炎抗体鸡尾酒现在将向美国食品和药物管理局申请完全批准。 这家大型生物技术公司周四宣布,它已经提交了该药物的BLA,申请批准在非住院患者中治疗新冠肺炎,并在某些个人中作为预防。监管机构批准了优先审查,将2022年4月13日定为PDUFA日期,Regeneron表示,该机构正在此前准备一份adcomm。 随着礼来公司努力将其内部和洛索团队整合成一个肿瘤学强国,这家制药巨头对CDK4/6抑制剂Verzenio寄予厚望,以帮助推动该组合进入未来。现在,这种药物在早期乳腺癌方面取得了改变范式的胜利--但礼来公司的市场计划会是一个有争议的诊断腿筋伴侣吗? 礼来在一份新闻稿中说,美国食品和药物管理局周三批准了CDK4/6抑制剂Verzenio与医生选择的内分泌治疗相结合,以降低高危HR阳性、HER2阴性乳腺癌患者的复发风险。