Thank you, next: Take da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re viv ing bat tered stock

谢谢你,下一篇:带上da hands Ovid 1.6亿美元现金,控制第三阶段--随时缴获毒品,重新销售库存

2021-03-04 04:01:13 ENDPOINTS NEWS

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Soticlestat made it. Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones. The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights. Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates. 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 Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the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. 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. GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan. The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday. A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement. The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance. Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one. Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms. 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. 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. One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies. The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.” They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.
索蒂克莱斯塔特成功了。 在委托奥维德大学的研究小组进行中期临床工作四年多后,竹田正将这种药物重新纳入自己的阵营。由于所有这些--在Dravet综合征和Lennox-Gastaut综合征中产生了他们认为是积极的第二阶段数据--生物技术公司获得了1.96亿美元的预付现金,另外6.6亿美元用于监管和商业里程碑。 这场全球大流行可能扰乱了经济,夺走了数十万人的生命,扼杀了整个行业,但它对生物制药风险投资的唯一影响是帮助该领域达到令人眩晕的新高度。 根据DealForma首席执行官Chris Dokomajilar的记录,以下是业内前100名风险投资家的排名,根据他们公开参与的交易数量排名。然后,数字大师计算出他们投入每笔交易的估计金额--按玩家人数分配现金--以表明他们是如何管理自己的辛迪加的。 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。 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。 葛兰素史克公司和Vir Biotechnology公司在接到NIH一项针对住院Covid-19患者的重大研究的邀请后,希望他们合作的抗体之一能够赢得胜利。但就像礼来一样,这对组合的药物不能击中目标,现在他们将被留在认真看比赛计划。 合作伙伴周三表示,NIH已经停止了GSK和Vir的抗体VIR-7831在其晚期Active-3试验中的注册,因为该药物在实现住院的Covid-19患者的持续康复方面显示出可忽略不计的效果。 一周多一点后,BrainStorm公司承认FDA的监管机构已经通知他们,该生物技术公司需要更多的数据才能获得ALS治疗NurOwn的批准--同时仍在吹捧疗效的“明确信号”,并不排除申请--该机构决定在一份最不寻常的声明中澄清记录。 FDA的声明完全是对自己的一记耳光,它提供的药效数据与该公司去年11月的公开声明不同,并且排除了任何统计意义的可能性。 过去十年,制药商已经证明JAK抑制剂可以治疗从类风湿性关节炎到COVID-19等一小部分免疫相关疾病。现在礼来又拿出了一个新的。 礼来及其生物技术合作伙伴Incyte周三宣布,他们的JAK抑制剂baricitinib在一项针对斑秃的III期试验中有效地修复了患者的头发。斑秃是一种会导致突然、严重和斑片状脱发的自身免疫性疾病。礼来没有对546名患者的试验结果进行分析,但主要终点是脱发症状标准评分的改善。 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“。 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。 欧洲最受瞩目的生物制药投资者之一将获得5.4亿美元,投资于新的跨界交易,为处于后期阶段的公司投资。 这家总部位于巴黎的风投公司表示,新的Sofinnova跨界基金融资使他们成为“欧洲最大的跨界投资者,致力于后期生物制药和医疗技术投资”。 他们在法国获得了法国政府颁发的“Tibi”特许权,从而获得了60亿欧元的资金池,帮助他们在机构投资者中获得了优势。自50年前成立以来,这家风险集团已经支持了500多家公司,目前管理着超过20亿欧元的资金。

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