d*****n
发帖数: 259 | 1 愚蠢，无知。。。
看看你丫的咖喱daddy怎么搞'falsified data'的。
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/
FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
Feb. 25, 2009
Media Inquiries:
Rita Chappelle, 301-796-4672
Consumer Inquiries:
888-INFO-FDA
FDA Takes New Regulatory Action Against Ranbaxy's Paonta Sahib Plant in
India
Agency halts review of drug applications from plant due to evidence of
falsified data; invokes Application Integrity Policy
The U.S. Food and Drug Administration today announced t... 阅读全帖 |
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g**********0
发帖数: 886 | 2 欧美制药业业在印度设厂实验室有他们的好处： 1.输出了污染大人力成本高的SECTION
, 2.有利
于做帐，高管与股市挂钩的利益来的快。 被老印山寨是这些利好的副作用。
下面这个报道说的是老印怎么用“法律”来忽悠的：
December 1, 2000
MEDICINE MERCHANTS / Pirated Pills
Selling Cheap 'Generic' Drugs, India's
Copycats Irk Industry
By DONALD G. McNEIL Jr.
Related Articles
• Issue in Depth: Medicine
Merchants
Forum
• Join a Discussion on Prescription
Medication
OMBAY — To anyone else, the room looks like the
unprepossessing office of a college science teacher.
But to the multinational pharmace... 阅读全帖 |
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s********s
发帖数: 579 | 3 【 以下文字转载自 Pharmaceutical 讨论区 】
发信人: smileashes (Pb), 信区: Pharmaceutical
标 题: 能干翻日本人的只有印度大哥了Daiichi Sankyo撤了
发信站: BBS 未名空间站 (Mon Apr 7 22:16:18 2014, 美东)
日本人终于收不了Ranbaxy了，把它卖给了一个印度企业Sun Pharma
Sun Pharmaceutical announced Monday a definitive agreement to acquire
Ranbaxy Laboratories under an all-share deal valued at approximately $3.2
billion. Daiichi Sankyo, which currently owns 63.4 percent of Ranbaxy, has
agreed to back the transaction and will hold an about 9 percent stake in the
merged com... 阅读全帖 |
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b*******e
发帖数: 724 | 4 A quick update on Liptor. I read the opinion after taking the conclusion from
someone else. It now looks like a weird situation may occur to Pfizer and
Ranbaxy. Pfizer's parent patent on Liptor is still valid, and will expire in
2009. however, Pfizer lost the claim 6 of their second patent, which expires
in 20011,therefore, they lost the suit against Ranbaxy.Between 2009-2011, both
Pfizer and Ranbaxy, and only those two, will be selling Liptor, because
Pfizer can still keep other generic makers |
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J**********i
发帖数: 925 | 5 来自主题: Pharmaceutical版 - 阿三作假被查 FDA: Ranbaxy Falsified Test Results
February 27, 2009
The U.S. Food and Drug Administration recently announced that a facility
owned by India-based
Ranbaxy Laboratories falsified data and test results in approved and pending
drug applications. The
facility, Paonta Sahib, has been under an FDA Import Alert since September
2008.
The FDA is continuing to investigate this matter to ensure the safety and
efficacy of marketed drugs
associated with Ranbaxy's Paonta Sahib site. To date, the FDA has no
e |
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s********s
发帖数: 579 | 6 日本人终于收不了Ranbaxy了，把它卖给了一个印度企业Sun Pharma
Sun Pharmaceutical announced Monday a definitive agreement to acquire
Ranbaxy Laboratories under an all-share deal valued at approximately $3.2
billion. Daiichi Sankyo, which currently owns 63.4 percent of Ranbaxy, has
agreed to back the transaction and will hold an about 9 percent stake in the
merged company with the right to nominate one director to Sun Pharma's
board
一个日本的分析师说的很好啊：他们(第一三共）输了全部，损失了40亿美元
"Financially they’ve lost everything – up to $4 bill... 阅读全帖 |
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i**T
发帖数: 3441 | 7 US Federal Drug Administration withdraws approval for a score of drugs from
Ranbaxy.
Meredith Wadman
The FDA move may herald greater scrutiny of generics in future.
PhotodiskRanbaxy Laboratories — India's biggest drug maker and one of the
largest generics firms in the world — has been slapped with tough penalties
by the US Food and Drug Administration (FDA) after it was repeatedly caught
falsifying data from one of its four Indian manufacturing plants.
The news thrusts a key member of the burgeo |
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n******d
发帖数: 244 | 9 Gilead Sciences, Inc. (NASDAQ:GILD), currently leading the hepatitis C
market by a huge margin, will see its blockbuster hepatitis C drug Sovaldi
now being sold for $10 as a generic version developed by Incepta
Pharmaceuticals Ltd. in Bangladesh.
Incepta’s generic version of Gilead’s top-selling drug is to sell for $900
for 12 weeks under the name Hopetavir. Gilead has already been criticized
for charging exorbitant prices for its HCV drugs. Sovaldi, proven to be
highly effective than the previo... 阅读全帖 |
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发帖数: 1 | 10 现在印度至少有20家制药企业通过了美国FDA认证，其中，南新(Ranbaxy)、西普拉(
Cipla)等正在成长为跨国制药公司，南新的非专利药目前已经在美国取得了10％的市场
份额。 |
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p**********u
发帖数: 15479 | 11 这个世界上没有FDA认证。只有中国和欧盟有。
: 现在印度至少有20家制药企业通过了美国FDA认证，其中，南新(Ranbaxy)、西普
拉(
: Cipla)等正在成长为跨国制药公司，南新的非专利药目前已经在美国取得了10％
的市场
: 份额。
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m**5
发帖数: 729 | 13 不是，Ranbaxy 好像名声不好，被FDA禁了？不过这个也是印度前5。 |
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c********r
发帖数: 562 | 14 Details released by the agency last week reveal that, since at least 2006,
Ranbaxy employees refrigerated samples that were supposed to be stored at
room temperature to test their stability over time. In another instance, the
plant reported stability test results for tablets of fluconazole, an
antifungal drug, and ciprofloxacin, an antibiotic reserved for severe and
life-threatening infections, as occurring at the required time intervals of
months; but employees actually conducted all the tests |
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g****y
发帖数: 72 | 15 熟话说,买的不如卖的精.
大公司收购之后整合成功的例子不多.风险很大.
就连pfizer收购 W-L 的确 Lipitor 来说,当时收购也是花了70 billion, 前一阵被判
Lipitor 钙盐( Pfizer Inc. v. Ranbaxy Labs.case)无效,专利保护期会缩短一年半,
如果不能翻案, 收购 W-L 的利润也难说了. |
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s********s
发帖数: 579 | 16 Daiichi Sankyo刚刚购买了印度做仿制药的Ranbaxy |
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b**u
发帖数: 2761 | 17 too old
Daiichi Sankyo刚刚购买了印度做仿制药的Ranbaxy |
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L******r
发帖数: 522 | 18 1米可能还不至于，我大概算了一下，每个ANDA成本大概增加$300,000-400,000，当然
这个估计很粗糙。看看GDUFA后面的推手（美国的generic, 欧洲的API厂），就可以很
清楚，GDUFA其实政治意味非常浓厚，带着明显的大鱼吃小鱼的特征。这也是没办法，
因为美国的这些generic公司，快要被老印搞得活不下去了，老印伪造数据，Ranbaxy只
是冰山一角而已。FDA现在根本批不了那么多ANDA，只能是提高门槛，很快就会有新的
guideline出来，对ANDA提高要求，不然不接受。再就是2013年FDA要开始执行QbD了，
所有这一切，都是对大的，技术实力强，有钱的有利，小的，以前靠偷工减料混得，日
子会越来越难。
Novast能不能活下去，也看在开始收钱之前，他们能拿到多少个approval，其余
pending的，就要交钱了。我个人还是比较看好他们。 |
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m*********3
发帖数: 1425 | 19 开年就layoff?另外amgen layoff 200
http://finance.yahoo.com/news/novartis-cut-transfer-4-000-11060
ZURICH (Reuters) - Swiss drugs group Novartis (NOVN.VX) intends to cut or
transfer up to 4,000 jobs, newspaper NZZ am Sonntag reported on Sunday,
citing an internal email.
The plan affecting up to 6 percent of its pharmaceuticals workforce comes on
top of a program to reduce the number of production sites and is part of a
larger drive to cut costs, the newspaper said.
Global drugmakers are under increasi... 阅读全帖 |
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e******e
发帖数: 57 | 20 来自主题: Pharmaceutical版 - 求救-丙肝 Generic Versions of Sovaldi
On Sept. 15, Gilead Sciences announced that it had signed a non-exclusive
licensing agreement with seven generic pharmaceutical manufacturers in India
to expand access to hepatitis C drugs. Cadila Healthcare Ltd., Cipla Ltd.,
Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd.,
Sequent Scientific Ltd. and Strides Arcolab Ltd. will now have permissions
to manufacture sofosbuvir, which will be marketed as Sovaldi.
“Hepatitis C is a significant public he... 阅读全帖 |
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e*n
发帖数: 1511 | 21 FDA Committee Votes to Reject AstraZeneca RSV Drug: Biotech's Latest Mishaps
The U.S. Food and Drug Administration's Antiviral Drugs Advisory Committee
has recommended that the agency reject MedImmune’s application to begin
marketing motavizumab, a monoclonal antibody for the prevention of serious
respiratory syncytial virus disease in high-risk infants. The committee's
recommendation, which was made with a 14 to 3 vote, calls for additional
clinical trials of motavizumab. The recommendation wil... 阅读全帖 |
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m****g
发帖数: 530 | 22 “即使在全球范围内，关于生物仿制药是否可以替代那些即将或已经失去专利保护的生
物药，仍是一个颇有争议的话题。
但是，印度制药公司正在全力以赴地推出生物仿制药产品，它们十分看好专利到期后生
物仿制药在发达国家的市场前
景。
像DrReddy、Biocon、Reliance和Ranbaxy等印度知名企业，都在积极扩充它们的生
物仿制药产品库，开发和生
产多种生物仿制药。”
目前全球市场上有150多种生物药，其中不少已经或即将失去专利保护。业内专家
估计，到2012年，生物药将占
FDA批准新药的大约一半。现在生物仿制药仅在11个国家销售，大部分产品在美国等国
家还无法上市。由此，生物仿制
药市场前景巨大。保守估计，生物仿制药市场开张的前十年至少有430亿美元的市值；
乐观估计，可能高达1080亿美元
的市值。连品牌药公司协会BIO和PRMA也不否认，生物仿制药入市竞争将大大降低医疗
保健费用。
印度公司进军生物仿制药十分积极，但所走的路各不相同。DrReddy公司选择专注
于自己擅长的肿瘤领域，认为生
物仿制药需要有自己的品牌，所以集中自己的产品优势，让自己的销售渠道可以派上用
场。Woc |
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