With stars aligned and cash in re serve, Bob Nelsen's Re silience plans a makeover at 2 new fa cil i ty ad di tions to its ...

与明星对齐和现金再服务,鲍勃尼尔森的再学院计划一个改头换面在2个新的fa i ty D i它的...

2021-03-03 18:31:10 ENDPOINTS NEWS

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Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape. Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling. The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs. In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders? Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday. Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line. President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported. When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors. Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family. AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease. The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression. It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though. “I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.” Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic. FibroGen will likely have to delay its US rollout for roxadustat once again. In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed. Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data. CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means. Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society. All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend. After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days. Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here. If this report was helpful in recapping it all for you, please do share it with your colleagues. On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.
鲍勃尼尔森的新的,最先进的药物制造计划正在形成。 仅在筹集了8亿美元的启动资金、一个梦之队董事会以及一个在Covid-19时代发现有太多瓶颈和低效率的领域进行改革的计划之后的三个月,复原力就抢购了两个正在等待重新改造的设施。 该公司从赛诺菲手中收购了位于波士顿的一家31万平方英尺的工厂,并在安大略省收购了一家13.6万平方英尺的工厂,以补充公司的运营网络。该公司首席执行官拉胡尔•辛格维表示,公司的运营才刚刚起步。与赛诺菲的交易伴随着一份继续生产其一种药物的合同。 去年年底,FDA命令百时美施贵宝放弃Opdivo在SCLC的审批,这可能是对那些利用验证性研究来支持加速审批的制药商的一次早期打击。现在,默克是下一个上火线的--我们看到FDA对上市后违法者的严厉打击了吗? 默克公司周一表示,该公司已经撤回了对转移性小细胞肺癌的PD-(L)1抑制剂Keytruda的上市批准,作为FDA对不符合上市后检查点的药物进行“全行业评估”的一部分。 默克公司在选择晚些时候加入新冠肺炎疫苗竞赛时进行了一场豪赌,并在1月下旬做出了一个同样重大的决定,即退出。现在,默克公司希望在这方面有所贡献,据报道,默克公司同意与其中一家已经冲过终点线的公司合作。 据《华盛顿邮报》报道,美国总统乔·拜登周二预计将宣布默克制药公司和强生公司合作,共同生产强生公司的重组蛋白新冠疫苗,该疫苗于周六获得FDA紧急使用授权。 当Michael Shpigelmacher开始这个项目时,他知道他必须自己出资。其他类似的努力都是学术性的,被投资者认为风险太大而拒绝。 Shpigelmacher是一名机器人专家,也是一名企业家,后来成为了制药公司的咨询师,他想要建立一种现实生活中的技术,这与上世纪60年代电影《神奇航行》中的技术相当,在这部电影中,一名潜艇船员被缩小到“大约一个微生物的大小”,并被派去修复一名科学家的大脑。他扫描了文献,找到了正在进行最先进项目的实验室--原来是在德国的马克斯普朗克研究所--并开始用自己账户的钱以及朋友和家人提供的一些种子资金资助这些项目。 在研究了帕金森氏症的临床前研究后,AbbVie完成了一项规模不大但耐人寻味的生物技术收购。 这家公司名为Mitokinin,是从加州大学旧金山分校的Kevan Shokat实验室分离出来的湾区生物技术公司,他的科学探索为该生物技术中心的一系列初创公司奠定了学术基础。Shokat在实验室的一名博士生尼古拉斯·赫兹利用他们在PINK1上的实验室工作与人共同创建了线粒体激肽,这表明增强其活性可能在调节线粒体功能障碍中发挥重要作用,这有助于帕金森病的发病和进展。“”PINK1“”PINK1“”PINK1“”PINK1“”PINK1“”PINK1“”PINK1“”PINK1“”PINK1“”PINK1“”PINK1“”PINK1“。 Paul Sekhri偶尔会想到,如果他们成功了,他的公司将登上《纽约时报》的头版,并成为地球上几乎所有主要新闻媒体的头版报道。不过,他尽量不去想这件事。 “我只想把注意力集中到这一点上,”塞赫里说,然后承认,“是的,我绝对想过了。” 塞克里是一名长期从事生物制药的高管,曾在赛诺菲和诺华任职。如今,他担任eGenesis首席执行官已进入第三年。eGenesis是乔治•丘奇的门生杨露汉创建的生物技术公司,旨在对猪进行基因改造,使它们能够用于器官移植。他带领他们通过了一个megaround,刚刚关闭了另一个,从17个不同的投资者那里筹集了1.25亿美元,将有史以来第一个(人化的)猪移植到人类的诊所。 FibroGen很可能不得不再次推迟在美国推出roxadustat产品。 在一个意想不到的举动中,FDA正在召集其心血管和肾脏药物咨询委员会,在一次咨询委员会会议上审查NDA。日期尚待确认。 就在几周前,SVB Leerink的分析师Geoffrey Porges预测,roxa的批准可能会在3月20日PDUFA的日期之前--尽管FDA在去年12月延长了审查期,但这一批准已经让人失望了一次。阿斯利康与FibroGen合作开发慢性肾病相关贫血药物,该公司透露,监管机构已要求对临床数据进行进一步的澄清分析。 CRLS.483s.CBER、CDER和RWE。对于生物制药专业人员来说,这些首字母缩略词之所以引起注意,是因为FDA在药物开发中起着重要作用。现在Endpoints正在加倍扩大监管覆盖范围,并推出一份关注White Oak公司发展的周报,并对这一切意味着什么进行分析和洞察。 报道将由我们新的高级编辑Zachary Brennan领导。他加入了POLITICO的端点,在那里他报道了制药。在此之前,他是管理事务专业人士协会的新闻刊物《管理焦点》的执行编辑。 引发第三波Covid-19疫苗供应开始席卷美国所需的所有部件都在周末顺利就绪。 在短暂地展示了监管的明智性后,FDA于周六紧急批准强生公司的新冠疫苗,为拜登政府旨在近期结束疫情的计划增添了一笔--至少是在美国。CDC于周日通过了批准,强生公司预计将在未来几天内开始提供疫苗。 欢迎收听《端点周刊》第三期,您对本周生物制药头条新闻的回顾。每周六早上都要在收件箱里放这个吗?当前端点读者可以访问他们的读者配置文件以每周添加端点。新到端点?在这里报名。 如果这份报告对你有帮助,请与你的同事分享。 本周早些时候,FDA审查人员对强生的单剂量疫苗给予了有力的支持--该疫苗在给药28天后证明对有症状的Covid-19的预防有效率为66%,对阻止严重疾病的有效率为85%--之后,该机构召集的咨询委员会一致投票建议批准其紧急使用。这是“一个相对容易的电话,”委员会的一个成员说--尽管这并不意味着他们没有问题。Jason Mast在这个直播博客上有讨论的亮点,包括公司的新信息。

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