Readers' Picks: Top 10 Stories of 2018

2018 BioSpace 年终大盘点:细数医疗保健行业十大新闻事件

2018-12-26 07:58:45 BioSpace

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As we look back over the year, we noticed some stories just grabbed readers more than others. Here’s a look at the top 10 stories of the year. #10. Genentech Cuts 223 Jobs at its Bay Area HQ. On August 16, Genentech announced it was slashing 223 jobs at its headquarters in South San Francisco. The layoffs were to go into effect on Aug. 31. Specific reasons for the cuts weren’t really described other than the layoffs followed a “business evaluation” and were expected to be completed by the end of November. #9. Drum Roll, Please! Top 10 Bestselling Drugs in the U.S. Although total worldwide prescription drug revenue is projected to reach $811 billion this year, the total revenue created by the top 20 drugs in the U.S. in 2017 alone was $135 billion. Some of the top drugs were AbbVie’s Humira; Regeneron and Sanofi’s Eylea; Celgene’s Revlimid; Biogen and Roche’s Rituxan; and Teva Pharmaceutical and Pfizer’s Enbrel. #8. Top 3 Takeover Targets for Pfizer. Readers love to gaze into crystal balls to predict the future, even if those crystal balls are cloudy. Analysts are always making predictions about mergers and acquisitions, and sometimes they’re right. Not so much this time. The top acquisition targets for Pfizer were Biogen, Bristol-Myers Squibb and Allergan, all still freestanding companies. #7. Theranos’ Elizabeth Holmes Charged with Fraud. The Theranos saga included more than a single story, but this particular one ranked number 7. After several years of following the dramatic story of Elizabeth Holmes, founder of Theranos, and the accusations against her and former company president Sunny Balwani of massive fraud, Holmes was charged with fraud in March 2018. The SEC complaints alleged that Holmes and Balwani made false and misleading statements during investor presentations and product demonstrations. In September, Theranos closed its doors for good. #6. Top 20 Life Science Startups to Watch in 2018. Every year, BioSpace analyzes biotech companies that launched in the last 18 months, apply a set of algorithms to key data, including finance, collaborations, pipeline, and innovation, to choose the Top 20 Life Science Startups to Watch. At the beginning of 2018, BioSpace published their “Class of 2018,” with the top spots going to BlueRock Therapeutics, Prelude Fertility, Relay Therapeutics, Freenome,and Cirius Therapeutics. #5. FDA Stuns Celgene With Refusal to File Letter for MS Treatment Ozanimod. In what turned out to be a huge embarrassment for Celgene, and a surprise to most industry watchers, the U.S. Food and Drug Administration (FDA) issued a Refusal to File letter to Celgene for its New Drug Application (NDA) for multiple sclerosis treatment ozanimod. What was most surprising was that a company with the size and experience of Celgene would have submitted an NDA that wasn’t complete enough to even be evaluated. Eventually, in June, the company admitted it made a mistake, although they essentially threw their Receptos subsidiary under the bus in the process. The company expects to file a second NDA in the first quarter of 2019. #4. Off-Label Use of Non-Opioids for Pain Appear to Rise in Response to Opioid Crisis. The opioid crisis and the Trump administration’s often fumbling attempts to address it received quite a bit of coverage in 2018. However, in November, reports came out that, partly as a result of government crackdowns on opioid use, physicians were increasingly using non-opioid therapeutics off-label in response. One example that was published described the use of Pfizer’s Depo-Medrol, an anti-inflammatory, being given in ways that were off-label and resulted in hundreds of complaints about injuries and complications from the injections. #3. NEJM Retracts Another Article Associated With Piero Anversa, Investigates Two More. There were several incidences this year of high-profile retractions, but the story that drew the most attention was about the New England Journal of Medicine retracting several papers about human lung stem cells. An investigation found that images used in the article had been manipulated. The stem cell article came from a lab affiliated with Harvard Medical School and Brigham and Women's Hospital. The lab was headed by Piero Anversa, a pioneer in cardiovascular research and a proponent of cardiac stem cells. Eventually, the two universities called for a retraction of 31 articles from various journals. #2. Another Biotech Conference, Another Party Involving Half-Naked Women Covered in Corporate Logos. This is yet another story that had multiple stories that also harkened back to similar stories from 2016 about the J.P. Morgan Healthcare Conference. At that meeting, some of the organizers of a party hired young women wearing skimpy dresses to mingle with the crowd. In this case, it was the annual Party at Bio Not Associated with Bio (PABNAB) in Boston in 2018 which featured topless dancers covered in body paint. The party had been criticized as “tone-deaf and lacking awareness” after widespread concern over gender equality throughout the biopharma industry. #1. At Last: Eli Lilly Publishes Data for Catastrophic Alzheimer’s Trial. Sadly, 2018 marked quite a number of Alzheimer’s clinical trial failures. But BioSpace’s most popular story involved Eli Lilly’s release of data from a failed Phase III Alzheimer’s trial of solanezumab. The original trial failure was announced in 2016, but Lilly held out hope that an analysis of subgroups of patients, especially those in the earliest stages of the disease, might salvage the trial and the drug. However, as published in the New England Journal of Medicine, the drug failed to reach significance in effectiveness. The story quite likely garnered interest in part because many critics and analysts believe it was the final nail in the coffin for the beta-amyloid theory of Alzheimer’s. It wasn’t, not by a longshot. Beta-amyloid plaques appear early in Alzheimer’s disease, and in fact, are found to appear 10 to 15 years before signs of the disease appear. Later in the disease, tangles of tau proteins are found. Many drugs in current trials focus on preventing, halting or clearing accumulation of beta-amyloid tangles. Although many of these drugs appear successful at doing this, trials have not shown significant improvements in cognition or memory. This has led some critics to say the beta-amyloid theory is dead. However, many in the field, compare beta-amyloid to a match that eventually sets off a cascade of “brushfire” events, including neuro-inflammation, that cause damage to the brain. This has led many companies to focus on earlier and earlier in the disease process, as well as to try other approaches. Here's to another great year, and thanks for being a loyal BioSpace reader! See you in 2019.
回顾2018年,我们发现了一些更能吸引读者的事件,这是其他故事所不能比拟的。以下是本年度十大事件。 #10。Genentech湾区总部削减223个工作岗位。 8月16日,Genentech 宣布在其南旧金山总部削减223个工作岗位。裁员决定于8月31日生效。除经“商业评估”以进行裁员外,该决定的真正原因不为所知。此举预计将在11月底完成。 #9。美国十大畅销药物,闪亮登场! 虽然今年全球处方药总收入预计将达到8110亿美元,但仅在2017年美国前20大畅销药物的总收入就高达1,350亿美元。这些顶级药物中,包括:AbbVie公司的消炎药Humira; Regeneron和Sanofi公司的眼药Eylea; Celgene的抗癌药Revlimid; Biogen 和 Roche公司的抗癌药Rituxan; 以及Teva Pharmaceutical 和Pfizer公司的风湿药Enbrel。 #8。辉瑞的三大收购目标。 读者们喜欢凝视水晶球来预测未来,即使水晶球混浊不清。分析师总是对兼并购做出预测,而他们时有成功。这次的预测就没那么准了。辉瑞公司的最大收购目标 是Biogen ,Bristol-Myers Squibb 和 Allergan,这些公司目前都还是独立公司。 #7。Theranos的伊丽莎白·霍姆斯被指控欺诈。Theranos相关的事件不仅仅是这一个故事。但这个故事排到了第7号。Theranos创始人伊丽莎白·霍姆斯与其原公司总裁Sunny Balwani 曾被指控大规模舞弊。就在伊丽莎白戏剧性遭遇的几年后,在2018年3月,她再次被指控欺骗罪。美国证券交易委员会的投诉指控Holmes和Balwani在投资者介绍和产品演示期间做出虚假和误导性的陈述。9月,Theranos彻底停业。 #6。2018年值得关注的20大生命科学初创公司。 每年,BioSpace 都会应用一组算法分析在过去18个月内创立的生物技术公司,其算法围绕关键数据,包括财务,合作,发展和创新,以选择20大值得关注的生命科学初创公司。在2018年年初,BioSpace 发表 了“2018年排行”,排名靠前的几大公司为:BlueRock Therapeutics,Prelude Fertility,Relay Therapeutics,Freenome 和Cirius Therapeutics。 #5。FDA意外拒绝Celgene公司的多发性硬化症疗法。 对于Celgene来说,这极为令人尴尬与失望,但对大多数行业观察者来说这是一个惊喜,美国食品和药物管理局(FDA)针对Celgene公司多发性硬化症疗法新药申请(NDA)发布了拒信。最令人惊讶的是,像Celgene这种规模和有经验的公司竟然会提交一份不完整甚至无法评估的NDA。最终,在六月,该公司承认了其犯下的错误,虽然他们基本上把锅甩给了Receptos子公司。该公司希望于2019年第一季度的提交第二次新药申请。 #4。面对阿片类药物危及,非阿片类止痛药的药品核准标示外使用情况增多。 阿片类药物危机和特朗普政府摸索中付出的努力在2018年得到了相当多的报道。然而,在11月,有报道称,在一定程度上由于政府对阿片类药物使用的打击,医生越来越多地通过非阿片类药物进行药品核准标示外使用的方法作为回应。报道中的一个例子描述了辉瑞公司抗炎药物Depo-Medrol,由于药品核准标示外使用的方法,导致数百起关于注射伤害和并发症的抱怨。 #3。NEJM收回与Piero Anversa相关的另一篇文章,另外两篇仍在调查中。今年发生了几次高调的撤稿事件,但吸引了最多关注的一次是新英格兰医学杂志收回了关于人肺干细胞的多篇论文。调查发现文章中使用的图像已被操纵。干细胞文章来自哈佛医学院和布莱根妇女医院附属实验室。该实验室由Piero Anversa领导,Piero Anversa是心血管研究的先驱和心脏干细胞的支持者。最终,两所大学要求撤回各大期刊发布的31篇文章。 #2。又一次生物技术会议,又一个涉及半裸女性的企业标志。 这是另一个有多个事件的故事,这些故事也回溯了2016年摩根大通医疗保健会议的类似情况。在那次会议上,聚会的一些组织者雇佣穿着轻薄连衣裙的年轻女性与人群互动。这一次则是2018年在波士顿举行的Bio Not Associated With Bio(PABNAB)年度派对,派对中出现了身体由涂料覆盖的裸照舞者。在整个生物制药行业普遍关注性别平等之后,该排队被批评为“毫无平等意识”。 #1。最后:Eli Lilly发布了阿兹海默症的“灾难性”失败试验数据。可悲的是,2018见证了多个阿兹海默症临床试验的失败。但BioSpace最受欢迎的故事是礼来公司发布的阿兹海默症药物solanezumab的III期试验的失败数据。最初的试验失败是在2016年宣布的,但礼来公司希望对患者亚组进行分析,特别是那些处于疾病早期的患者,可以挽救试验和药物。然而,正如“ 新英格兰医学杂志”报道称,该药物未能达到显著有效性。 这个故事很可能会引起人们的兴趣,因为许多评论家和分析家认为这将会是压倒阿尔茨海默氏症β-淀粉样蛋白理论的最后一根稻草。并非如此,至少长远来看不是这样。β-淀粉样斑块出现在阿尔茨海默病的早期,事实上,在疾病迹象出现的10至15年之前,它们就已经出现了。在疾病的后期,则会出现Tau蛋白缠结。 当前试验中的许多药物都集中于预防,停止或清除β-淀粉样蛋白缠结。尽管这种药物很多都在这方面取得了成功,但试验并未显示出认知或记忆方面的显著改善。这导致一些批评者认为β-淀粉样蛋白理论已破。然而,该领域中的很多人都把β-淀粉样蛋白比作最终会引发一系列“连环火焰”的火柴,包括导致大脑损伤的神经炎症。 这导致许多公司都越来越关注阿兹海默症的早期阶段,以及尝试其他方法。 又是一年好风光,BioSpace衷心感谢您在这一年的陪伴。让我们相约2019。

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