每一天生物医药产业都会发生无数的大事，而这些新闻都会直接影响着我们每一个人。尤其是今年以来，专利悬崖的到来、癌症免疫疗法的兴起、生物医药产业兼并重组等等都吸引了从生物医药产业到金融业所有专业人士的眼球。最近FiercePharma通过统计一年以来的新闻点击率，总结出了2014年最吸引人眼球的十大新闻。辉瑞公司、阿斯利康公司、诺华公司、赛诺菲公司、葛兰素史克公司和吉利德公司等纷纷上榜。而大家关注的重点也涵盖了公司裁员、仿制药市场、药物价格和公司丑闻等方面。
一、FDA批准辉瑞开发阿斯利康畅销药埃索美拉唑非处方版本
今年以来，生物医药产业企业兼并领域中最为吸引人眼球的一个新闻就是辉瑞公司试图收购阿斯利康公司。不过，今天，辉瑞公司和阿斯利康公司并不是因为这一收购案而登上这一榜单。今年三月份，FDA最终做出决定批准辉瑞公司开始研发阿斯利康畅销药物埃索美拉唑的非处方版本。埃索美拉唑是阿斯利康公司2000年9月份正式开始销售这种药物，埃索美拉唑主要是治疗胃食管反流性疾病等疾病，这一药物自从上市以来，为阿斯利康公司带来了数以亿计的收入。而由于专利悬崖的到来，阿斯利康公司一直试图避免来自仿制药的挑战。此次，辉瑞公司与阿斯利康公司合作，来开发这种药物的非处方药版本，也不失为一个明智之举。
二、诺华公司宣布全球裁员4000余个岗位
2014年是生物医药公司兼并重组最为激烈的一年，然而伴随着不同公司的兼并重组，裁员问题是一个无法回避的问题。诺华公司在今年二月份就宣布对公司的全球部门进行业务重组。整个计划中预计裁员将达到4000余人。这其中不仅包括了今年年初公司在瑞士的500余人裁员计划，公司还计划关闭在纽约的一个药物生产厂家，该工厂的535名工作人员也不幸进入这一裁员名单中。这也是诺华公司继2012年、2011年十月份两次大规模裁员后的又一大动作。不过正所谓是有人欢喜有人忧，诺华公司在调整精简了这些地方的机构后，决定将增加来自印度、中国等市场的工作岗位。经过调整后，诺华公司在全球的员工数量仍将保持稳定。
三、诺华公司在日药物研发工作丑闻风波
药物研发的过程中最为重要的就是研究人员对待数据的绝对中立。偏离了这一准则，所有的药物研发过程都将变得毫无意义。这也必然直接危害到广大患者的切身利益。这也是为什么今年年初，诺华公司白血病药物Tasigna研发工作中出现丑闻而在日本、乃至世界生物医药产业引起地震的根本原因。事情的起因在于在进行Tasigna临床研究的日本医院中，有人违规将具体病人信息透露给诺华公司的研究人员。这使得药物研发过程中的双盲原则被严重破坏。而诺华公司被认为将这些数据提交给日本相关医药部门，以完成一些相关手续的批准。
四、吉利德公司树大招风，Sovaldi价高遭人诟病
如果说谁是近两年来生物医药产业研发的最大赢家，吉利德公司一定是热门人选之一。公司开发的治疗丙肝鸡尾酒疗法Sovaldi在经过FDA的快速审查批准后迅速在丙肝市场上引发了一场海啸，并被几乎所有的分析人士认定为这一市场未来的绝对霸主。然而，Sovaldi也为吉利德公司招致了不少的非议，其中最主要的就是Sovaldi整个治疗过程中高达8万美元的售价。而今年四月份Express scripts公司公布的一份市场调查报告更将这一质疑推上了一个新的台阶。Express scripts公司通过调查了2013年丙肝市场药物的价格情况后，宣称2014年-2016年丙肝病人治疗的成本将激增1800%，而这一矛头直指吉利德公司的Sovaldi。另一方面，吉利德公司为了在发展中国家打开市场，计划与这些国家的仿制药生产厂家合作推出廉价版的Sovaldi，相比于美国市场28天一疗程高达28000美元的天价，这一版本的药物仅为300美元。美国人民因此"暴走"也就在意料之中。
五、葛兰素史克中国贿赂案
随着近些年来的飞速发展，以中国为代表的海外新兴市场已经成为了各大生物医药巨头的必争之地。然而，2013年夏天，葛兰素史克公司中国分公司则因为一些不光彩的原因而成为世界关注的焦点，国内外媒体也纷纷开始拷问这些跨国生物医药巨头，如何能够保证所属分公司能够遵守当地的相关法律法规。在这场事件中，葛兰素史克分公司的众多高管都纷纷落马，素有葛兰素史克中国分公司"四架马车"之称的法务部总监赵虹燕，；副总裁、企业运营总经理梁宏，商业发展事业企业运营总经理黄红以及副总裁兼人力资源部总监张国维私人纷纷卷入其中。这一事件甚至引起了美国司法部的关注。可以预见，在今后的数年内，在中国乃至全世界市场中，生物医药产业中都将兴起一场反贿赂的风暴。
六、Pradaxa、Xarelto围剿Eliquis扞卫其在抗凝血剂药物市场地位
抗凝血剂在当今的生物医药产业中占有举足轻重的地位。无论是关节炎、心血管疾病都会广泛应用此类药物。而这一市场则成为生物医药巨头们都想分润的一个大蛋糕。然而这些药物都可能出现严重的副作用。因而医生在开具此类药物时都十分慎重。当FDA表示辉瑞公司和施贵宝公司联合开发的Eliquis更有效、更安全时，在抗凝血剂市场分庭抗礼的两大药物Pradaxa、Xarelto背后的强生、拜耳以及勃林格殷格翰公司不约而同的将枪口一致对外。他们都纷纷表示，首先在过去几年中Pradaxa、Xarelto在欧洲和美国市场虽然都出现了副作用案例，但是案例数目相较于使用这两种药物的庞大基数，仍然属于可接受范围内。同时，他们还认为将一种新上市抗凝血剂药物的不良反应事件数与两种老牌抗凝血剂药物的不良反应事件数进行比较是一种不恰当的做法。由此看来，辉瑞公司和施贵宝公司如果想在抗凝血剂药物市场中分上一杯羹，或许还要面临更激烈的挑战。
七、美国国会要求吉利德澄清Sovaldi定价问题
中国有句戏语--十个劫道的不如一个卖药的。这句带着很大戏谑成分的话用在吉利德公司治疗丙肝的超级新药Sovaldi上似乎是再合适不过了。吉利德公司开发的这种丙肝鸡尾酒疗法能够在十几周的时间内彻底治愈丙肝，从而促使FDA在审批道路上一路绿灯，以创纪录的速度登陆美国市场。然而其令人嗔舌的价格也广为生物医药产业人士所诟病。终于在今年六月份，这一问题也吸引了美国国会的关注。美国国会议员Henry Waxman等人致信众议院能源和商务委员会要求吉利德公司在国会上澄清这一定价问题的合理性。Henry Waxman表示吉利德公司高达8万4千美元的定价将使美国国家老年人医疗保险体系成本增加数十亿美元。他估计仅2015年这一数字就将达到65亿美元，增长了约8%。而吉利德公司此前一直坚称公司对Sovaldi的定价并无不妥。相比于丙肝这种慢性疾病带来的长期花费，Sovaldi的定价已经十分良心了。不过，不知道美国从国会到政府是否会接受这一解释。不论情况如何，吉利德公司在未来数年凭借Sovaldi也会赚个盆满钵满。
八、诺华畅销药物Diovan仿制药或于2014年4月到来
诺华公司的降血压重磅药物代文（Diovan）在过去几年中为这家瑞士的生物医药巨头带来了数以亿计的收益。但是随着专利悬崖的到来，这一药物将或收到多个仿制药的挑战。公司在今年年初预计这一药物的仿制药或将于2014年四月份到来。此前诺华公司曾预计2013年是代文面临挑战的一年。但是由于持有这种药物仿制权的Ranbaxy公司始终未能推出这一药物，使得诺华公司在2013年得以平稳度过。公司由于仿制药竞争的收入损失降低了约23亿美元。
九、赛诺菲公司CEO深陷与董事会纷争被迫离开
一家公司的CEO掌握着这个公司的发展方向。当这个CEO与公司的董事会发生冲突时会发生什么？今年下半年赛诺菲公司的CEO Chris Viehbacher就面临着这样的问题。作为赛诺菲公司首个非法国CEO，自从他于2008年接掌赛诺菲以来，采取了一系列措施对这家生物医药巨头进行重组，其中就包括裁剪公司在法国的员工数目，这也引发了他与赛诺菲董事会的冲突。这一冲突在今年愈演愈烈并最终导致Chris Viehbacher离职。而在2014年剩下不多的时间中，赛诺菲公司面临的一个重要问题是--自家的CEO去哪啦？
十、强生、Pharmacyclics治疗罕见白血病药物Imbruvica每片90美元！要钱还是要命？
2013年十一月，FDA宣布强生公司和Pharmacyclics公司开发的治疗罕见白血病药物Imbruvica被批准上市。然而随后强生公司对Imbruvica的定价让人大跌眼镜。强生公司将其每片定价为90美元。按照这种药物每日四片的剂量，患者每年将为其支付高达13万美元！而这也成为今年来上市的抗癌药物中最为昂贵的一种。此前，Dendreon 公司的前列腺癌疗法 Provenge和施贵宝的黑色素瘤疗法 Yervoy分别定价9万美元和12万美元，都已经引起了一片哗然。不过不同于最近的土豪药物Sovaldi，Imbruvica的主要治疗适应症是一种罕见的白血病，每年仅有2900名患者被却怎为这种疾病。因此，相应的保险体系有足够能力负担这一药物。（生物谷Bioon.com）
详细英文报道：
We publish, you pick: FiercePharma's 10 best-read stories of 2014
Every day, we sort through hundreds of email pitches, press releases, SEC filings, analyst notes, trial data announcements, journal articles, research reports, news digests and alerts. We listen on Twitter and scour the web. We choose which stories to present to you, our readers.
once a year, we let you do the honors. We check our web traffic for the best-readFiercePharma articles of the year. It's pharma news chosen by pharma readers, a crowdsourced list of the most compelling, important, sensational or controversial stories since New Year's.
In 2014, we had all of the above, starring Pfizer ($PFE), AstraZeneca ($AZN), Novartis ($NVS), Sanofi ($SNY), GlaxoSmithKline ($GSK) and Gilead Sciences ($GILD). Pfizer and Novartis each show up in three headlines. AstraZeneca and Gilead account for two apiece. GSK and Sanofi boast just one each--and we bet you can guess their subjects.
Topics? Job cuts, generic competition, ethics lapses, pricing controversy--and one big battle between a Big Pharma's board and its CEO.
Pfizer and AstraZeneca share top billing in the best-read story of the year, but it's not the news you might expect. It's Pfizer's green light for an over-the-counter version of Nexium, AstraZeneca's gastrointestinal blockbuster, which went off patent in May. AstraZeneca struck an OTC deal with Pfizer in 2012, in a bit of a hedge against the inevitable generics. But even now, the OTC drug is the only rival to good old branded Nexium. Thanks to longstanding manufacturing problems,Ranbaxy Laboratories couldn't launch its copy, and it's first in line with exclusive 180-day rights. In mid-November, the FDA pulled Ranbaxy's tentative OK for the drug, delaying its version even further. So far, the agency hasn't allowed any other would-be copycat to step into the breach--and AstraZeneca CEO Pascal Soriotsays he doesn't expect another Nexium rival till next year.
Novartis enjoyed a similar reprieve on generic Diovan, a story that stands in 9th place on our list. After months of delays--and billions in unexpected brand sales for Novartis--Ranbaxy was able to launch its Diovan copy in June. But in the meantime, as the drugmaker prepared for that competition, it rolled out the restructuring plan that's our runner-up for best-read-story of the year. Novartis plotted thousands of job cuts and a business services consolidation in India, part of a push to streamline its operations worldwide.
Novartis also captured third place, with an ethics scandal in Japan. A Tokyo hospital chief admitted that Novartis employees--including sales reps--carried water for researchers in a trial assessing the side effects of several leukemia drugs, including the Swiss drugmaker's old-but-breakthrough-drug Gleevec and its follow-up, Tasigna. It wasn't the only trial-data lapse, either. Novartis pharma chiefDavid Epstein had already apologized for a former employee's involvement in a Diovan trial--the same trial that landed Novartis in hot water with government prosecutors, which charged the company for false advertising.
Surprisingly enough, that single story outranked a bigger ethics scandal: Glaxo's Chinese bribery snafu. Though thousands more readers have followed that particular investigation story-by-story, the single piece of news that managed to crack our top 10 was perhaps the most sensational: GSK's former China chief Mark Reilly, since sentenced and deported for his role in the $493 million bribery scheme, was secretly videotaped in bed with his girlfriend. By itself, not newsworthy. But the video prompted Glaxo to hire private investigator Peter Humphrey, who ended up front-and-center in China's corruption probe. Humphrey was later sentenced to two years in prison for collecting private information on Chinese citizens.
A less salacious controversy takes both fourth and seventh place: Gilead's $84,000 price on its hepatitis C treatment Sovaldi. Notorious with cost-conscious payers, famous as the fastest blockbuster launch in history, and lauded as a game-changing cure for a devastating liver disease, Sovaldi made more headlines in 2014 than any other single drug. Express scripts ($ESRX) CMO Steven Miller, perhaps the most vocal critic of Gilead's pricing decisions, had predicted that treating U.S. hep C patients would cost $300 billion at that rate--an endeavor that could "break the country." Our fourth-place story focused on the pharmacy benefits manager's annual spending report, which predicted an 1,800% increase in spending on hep C from 2014 to 2016, as more pricey-but-effective drugs hit the market.
And then Congress got into the act. Reps. Henry Waxman and Diana DeGette wrote the House Committee on Energy and Commerce, lamenting Sovaldi's potential burden on Medicare drug spending. Some $6.5 billion in 2015 alone, they said, demanding a hearing about that $84,000 list price. That story wasFiercePharma's 7th best-read of the year.
A headline-making price grabbed 10th place, too. Johnson & Johnson's new blood cancer drug Imbruvica won approval late last year, too late to qualify for the 2013 best-read list. J&J tagged it with a $130,000-per-year-price. Just as they are with the Sovaldi saga, readers are hooked on the story of pricey cancer drugs, and the patients and payers who have to foot the bill for them.
Want more controversy? Check out 6th place, wher side-effects data provider AdverseEvents stirred up a debate over the safety of a new group of anticoagulants. After sifting and analyzing the FDA's database of adverse event reports, the company concluded that Pfizer and Bristol-Myers Squibb's ($BMY) entrant, Eliquis, was the safest of the bunch. Some clinical trial data had already suggested as much. But the makers of Pradaxa (Boehringer Ingelheim) andXarelto (Johnson & Johnson and Bayer) argued that the FDA's data isn't reliable enough for such a conclusion. With the agency's adverse events data attracting closer attention from AdverseEvents and others, more arguments are sure to come.
Which brings us to a private argument that went very public--and ended in unemployment for Sanofi's now-former CEO, Chris Viehbacher. News thatViehbacher was on the outs with Chairman Serge Weinberg and Sanofi's board broke on Oct. 27. Like a slow-motion train wreck, the battle played out in headlines, with a leaked letter on Monday, terse comments from Viehbacher during the company's third-quarter earnings call Tuesday, and a critical post mortem Wednesday, when Weinberg announced that Viehbacher had been fired. By Halloween, enough people had read Viehbacher's tale of woe to vault that 5-day-old story into 7th place for the entire year.
We'd be remiss not to point out a couple of the year's biggest stories that didn't make the cut: First, there's Pfizer's failed attempt to buy AstraZeneca in May. Under U.K. takeover rules, Pfizer can make another run at a deal this month. But will it? Perhaps only CEO Ian Read knows for sure. And then there's the Novartis-GlaxoSmithKline-Eli Lilly sale-and-swap, announced in April. In one of the biggest deals of the year--and certainly the most complicated--Novartis bought Glaxo's cancer business and sold Glaxo its vaccines unit, and the two agreed to team up in a consumer health joint venture. As for Lilly, it picked up the Novartis animal health business as part of the bargain.
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