f**********g 发帖数: 2252 | 1 3rd UPDATE: FDA Panel Backs Use Of Orexigen's Proposed Weight-Loss Drug
Contrave
Tuesday 12/07/2010 7:06 PM ET - Dow Jones News
Related Companies
Symbol Last %Chg
ARNA 1.66 17.73%
OREX 10.82 127.31%
VVUS 9.00 15.38%
As of 9:35 AM ET 12/8/10
(Updates after-hours share movement)
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--A federal advisory panel Tuesday backed the use of a
proposed weight-loss drug from Orexigen Therapeutics Inc. (OREX), saying
potential safety conce... 阅读全帖 |
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v**********m 发帖数: 5516 | 2 Orexigen Revives Obesity Drug Development With FDA Agreement
Q
By Ryan Flinn - Sep 20, 2011 4:38 PM ET
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Orexigen Therapeutics Inc. (OREX) is renewing development of the
experimental obesity drug Contrave after reaching an agreement with U.S.
regulators to further study heart risks.
Orexigen, one of three companies with rival obesity treatments competing for
approval, will start a two-year clinical trial of about 10,000 patients in
the first half of next y... 阅读全帖 |
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v**********m 发帖数: 5516 | 3 Orexigen Revives Obesity Drug Development With FDA Agreement
Q
By Ryan Flinn - Sep 20, 2011 4:38 PM ET
inShare1
More
Print
Email
Orexigen Therapeutics Inc. (OREX) is renewing development of the
experimental obesity drug Contrave after reaching an agreement with U.S.
regulators to further study heart risks.
Orexigen, one of three companies with rival obesity treatments competing for
approval, will start a two-year clinical trial of about 10,000 patients in
the first half of next y... 阅读全帖 |
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v**********m 发帖数: 5516 | 4 来自主题: _pennystock版 - OREX Orexigen® Therapeutics Provides a Regulatory Update on Contrave® NDA
0
0
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My news for Investors
AtLeast one of the check box should be selected You are following news about Follow the latest news about OREX
SAN DIEGO, June 3, 2011 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced today that it recently met with the Food and Drug Administration (FDA) regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets fo... 阅读全帖 |
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D******9 发帖数: 2665 | 5 不过好像我这把赌对了, 呵呵
Orexigen Wins Panel’s Backing for First Diet Pill in a Decade
December 07, 2010, 4:26 PM EST
Dec. 7 (Bloomberg) -- Orexigen Therapeutics Inc. won a U.S. panel’s backing
for Contrave, a new prescription diet pill.
Contrave’s benefits in helping obese people lose weight are greater than
the drug’s potential long-term risks, outside advisers to the Food and Drug
Administration said today in a 13- 7 vote at the agency’s headquarters in
Silver Spring, Maryland. The panel earlier said a... 阅读全帖 |
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v**********m 发帖数: 5516 | 7 Orexigen Therapeutics, Inc. And FDA Identify Clear And Feasible Path to
Approval for Contrave
4:00pm EDT
Orexigen Therapeutics, Inc. announced that following a recent meeting with
senior officials in FDA's Office of New Drugs (OND), the Company received
written correspondence detailing OND's design requirements for a
cardiovascular outcomes trial (CVOT) for Contrave that would address the
Complete Response Letter (CRL) received in January 2011 . Orexigen believes
that these design requirements a... 阅读全帖 |
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O**I 发帖数: 776 | 8 【 以下文字转载自 pennystock 俱乐部 】
发信人: OSCI (TX), 信区: pennystock
标 题: FDA Drug Approvals in 2011
发信站: BBS 未名空间站 (Sat Jan 8 17:29:50 2011, 美东)
http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
... 阅读全帖 |
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s**********9 发帖数: 846 | 9 The regulatory package for Contrave is extensive, and we believe, compelling
. It contains the interim analysis data and all the previously submitted
data from the core Phase 3 program in a broad and generalizable patient
population. As Mike noted, we will resubmit the Contrave NDA in the next few
weeks.
http://seekingalpha.com/article/1861981-orexigen-therapeutics-m |
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p********e 发帖数: 1960 | 10 周末刚刚被某娱乐周刊评为2014的潜力股
2014 Top health-care stock No. 1: Joining the pack
It's a heck of a lot easier to determine the potential value a biotech when
there's a company further ahead with nearly identical assets. Orexigen (
NASDAQ: OREX ) has two.
The biotech is developing an obesity drug Contrave, which will be reviewed
by the FDA in 2014. Further ahead, Arena Pharmaceuticals (NASDAQ: ARNA )
developed obesity drug Belviq that launched this year. VIVUS (NASDAQ: VVUS
) sells Qsymia, which has bee... 阅读全帖 |
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p***o 发帖数: 714 | 11 Unlike U.S. Food and Drug Administration drug approvals, which are more
precisely timed, the release dates for data from clinical trials is bit
fuzzier, so the timelines here are culled from company guidance when
possible.
The working list of clinical trials expected to complete in 2009 is fairly
long, so expect more information on clinical trials to watch in the coming
weeks.
Company: GTx(GTXI)
Drug/indication: Acapodene for precancerous prostate lesions (high-grade PIN)
Clinical trial event: p... 阅读全帖 |
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O**I 发帖数: 776 | 13 http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
Orexigen Therapeutics Inc.| OREX
DOWN
Dendreon Corporation| DNDN
InterMune Inc.| ITMN
For easy reference, I've organized this regulatory ... 阅读全帖 |
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O**I 发帖数: 776 | 14 http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
Orexigen Therapeutics Inc.| OREX
DOWN
Dendreon Corporation| DNDN
InterMune Inc.| ITMN
For easy reference, I've organized this regulatory ... 阅读全帖 |
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w*******0 发帖数: 13 | 15 BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
For easy reference, I've organized this regulatory calendar in chronological
order based on the drug approval decision date. I've also included
information on pending FDA advisory panels. At the end of the calendar is a
list of companies with potential regulatory milestones in 2011 based on
expected but not yet completed drug approval filings.
In all, this calendar ... 阅读全帖 |
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w*******0 发帖数: 13 | 16 BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
For easy reference, I've organized this regulatory calendar in chronological
order based on the drug approval decision date. I've also included
information on pending FDA advisory panels. At the end of the calendar is a
list of companies with potential regulatory milestones in 2011 based on
expected but not yet completed drug approval filings.
In all, this calendar ... 阅读全帖 |
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v**********m 发帖数: 5516 | 17 Arna pump新文。
http://seekingalpha.com/article/292994-is-arena-s-lorcaserin-on
Is Arena's Lorcaserin On Track For Approval In 2012?
28 comments | by: KLLJ Investments September 12, 2011 | about: ARNA
Arena Pharmaceuticals (ARNA) investors have had a tough road over the last
12 months since a negative vote by an Advisory Committee called to review
Arena’s lead drug candidate for the treatment of obesity – lorcaserin. The
stock was trading close to $7.00 a year ago heading into that fateful
Advis... 阅读全帖 |
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V**n 发帖数: 560 | 18 sorry, a big IF. Maybe a higher chance of REMS...
三种药中间 Lorcaserin 减肥效果比 contrave Qnexa 来的小, 但是副作用也小很多
, 如果你去读一下那些报告。
Qnexa ruled out for child bearing age females this is a red flag to me...
而且其实说白了,正好是这些爱美的女人是减肥药的主力吧!
我相信医生也会开相对谨慎的药。
当然,股票最重要的是顺势而为,science, data 较真是不智的。
现在美国成年人 1/3 超重, FDA 13年来都没有批过减肥药; Qnexa 就像老板没钱的
时候,你觉得他想不想你答辩通过呢? 通过以后有没有锦绣前程 那他就不管了。 |
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r*****g 发帖数: 116 | 19 OREX 的减肥药Contrave, 17号过FDA。借着ARNA通过FDA已经连涨两天,今天不出意外
会小涨或略跌。
按照ARNA的估值18亿,目前OREX 4亿的估值应该还有很大的上升空间,保守一点15~
16。此外,个人以前认为OREX 通过FDA的可能性远大于ARNA,但赌FDA是纯粹
赌博,还是要慎重!
P了个S:一直觉得ARNA过不了FDA,但上升的空间是有的,竟然通过!价格估对了,
结果没对,呵呵。接下来ARNA应该就是慢慢走低,7~8之间。 |
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e*****6 发帖数: 278 | 20 需要下面这篇文章。好心人可否将此文的pdf发至x*****[email protected]
万分感谢!
Curr Opin Investig Drugs. 2009 Oct;10(10):1117-25.
Contrave, a bupropion and naltrexone combination therapy for the potential
treatment of obesity.
Padwal R.
Department of Medicine, University of Alberta Hospital, 2F1 26 Walter C
Mackenzie Health Sciences Centre, Edmonton, AB T6G 2B7, Canada. rpadwal@
ualberta.ca |
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h***e 发帖数: 7320 | 21 我们开个主题,肥猪和哈密我每天更新,希望大家能找到好匹克
如果大家发现新的event, 也请及时跟帖update,非常感谢 :)
Event Thread 不是推荐股票,欢迎讨论。
先给大家总结10月份的,以后每月开一贴哈
====================================
发信人: justsing (飞天的猪), 信区: pennystock
标 题: Re: 【Biotech Event Thread】
发信站: BBS 未名空间站 (Thu Oct 15 22:23:05 2009, 美东)
potentially stock-moving biotech events for October:
Oct. 5-6
JMP Securities Healthcare Focus conference
Oct. 7-8
Cowen & Co. 12 th Annual Therapeutics Conference
Oct. 8
FDA approval decision date for Spectrum Pharmaceuticals'(SPPI Quo... 阅读全帖 |
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r***e 发帖数: 653 | 22 2月份,PLX (2/7), DDSS (2/11), CADX(2/12), XNPT (2/9), CTIC (2/10,Panel
Review), CRXX(2/22,估计要被据)
3月份: SUPG (3/8, 不是SUPG自己的), APPA (3/18,估计很玄), SOMX (3/21, 三进宫了),MNTA (3/31), STAA (3/31),
4月份:CYTX(4/7),CTIC(4/23,估计2月10结果就差不多出来了),POZN(4/30),
PLX: taliglucerase alfa for Gaucher's disease, FDA orphan drug and fast
track designation, 有pfizer的背书,临床结果好于竞争对手Genzyme的Cerezyme.三期
临床试验证明了安全和疗效,作为一个protein drug,只有6%的病人体内产生抗体.结果
不错.
DDSS:去年7月份悲剧是因为生产设施的问题,FDA没提疗效和安全的问题.这次是志在必
得.
CADX:IV acetaminophen (Acetavanc... 阅读全帖 |
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g******0 发帖数: 1165 | 23 Posted: 2/20/10 15:05
简单再说一下三个减肥药, 算是最后的总结: 我认为在FDA决定前三个股票都可以trade
, as far as you buy low and sell high. The only reason I recommended VVUS in
the past is from speculative FA speaking, it is in relative stronger
position. And market do agree with me.
我以前没怎么提,但是减肥药费用不能保险公司支付, insurance companies don't
reimburse obesity drugs这点很重要. 也许这个市场并非象好多人想象的那么大, 另
外有效性不高的药(ARNA 3.6%, OREX 4.5%)即使批准也很难说服病人放弃高效的药(
VVUS 10%)或是便宜的药(metformin, sibutramine, phentermine, bupropion, and
topiramate 3-6%, cheap gener... 阅读全帖 |
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h*****8 发帖数: 4754 | 24 根据今天的收盘价,它们给的TARGET的涨幅
OREX>ARNA>VVUS
Davenport & Co. Starts Three in the Obesity Therapeutics Sector (ARNA, OREX,
VVUS)
May 7, 2010 10:07 AM EDT
Davenport & Co. starts three Obesity Therapeutics companies today:
* Arena Pharmaceuticals (Nasdaq: ARNA) with a Buy rating and price
target range of $5 - $6. The firm cites confidence in Lorcaserin weight
management agent, whose phase III have achieved solid results. The NDA filed
with the U.S. SEC was accepted, and they expected review in Q310.
S... 阅读全帖 |
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f**********g 发帖数: 2252 | 25 3rd UPDATE: Abbott Halts Meridia Sales In US, Canada, Australia
Friday 10/08/2010 1:35 PM ET - Dow Jones News
Related Companies
Symbol Last %Chg
ABT 52.80 -0.02%
ARNA 1.82 3.43%
GSK 41.34 -0.24%
OREX 6.32 1.77%
RHHBY 35.24 -2.11%
As of 10:11 AM ET 10/12/10
(Adds detail, background.)
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--Abbott Laboratories (ABT) said Friday it was pulling
Meridia off the U.S., Canadian and Australian markets at the request of
health regulators... 阅读全帖 |
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y*****l 发帖数: 5997 | 26 盘前到8块了?!
FDA Rejects Vivus Inc.'s Obesity Drug Qnexa
Thursday 10/28/2010 9:18 PM ET - Dow Jones News
Related Companies
Symbol Last %Chg
ARNA 1.59 0.00%
VVUS 6.13 0.00%
As of 4:00 PM ET 10/28/10
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--The Food and Drug Administration rejected Vivus Inc.
's (VVUS) obesity drug Qnexa, the company said Thursday.
The rejection marks the second time in less than a week that the agency has
refused to sign off on... 阅读全帖 |
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v**********m 发帖数: 5516 | 28 楼上文章的comments
Not yet but stay tuned. But a definite fact and you can review it in the FDA
's analysis in the briefing document is that there was no SS of astrocytomas
in male rats or female rats.
Dr. Alavi had concerns about how Arena calculated the exposure margin for
Lorcaserin, that is why it appeared in the CRL. When Arena met directly with
the FDA on December 15th and 16th at the FDA, both Arena and the FDA agreed
on the CSF methodology and the number of participants that would be
acceptab... 阅读全帖 |
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y*****l 发帖数: 5997 | 29 22 Hot Drugs Facing FDA Approval in 2012
By Adam Feuerstein 11/29/11 - 08:55 AM EST
BOSTON (TheStreet) -- Here's your first look at the biotech and
pharmaceutical companies with pending FDA drug approval decisions in 2012.
The calendar on the following pages captures nearly two-dozen U.S.
regulatory events -- FDA drug approvals and advisory panels -- expected
between December 2011 and July 2012. As every savvy biotech investor and
trader knows, the volatility in biotech and drug stocks ramps sig... 阅读全帖 |
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y****o 发帖数: 329 | 30 医药里面的股,我只炒过sppi.确实没注意过减肥方面的。我是搞pharmaceutical的,
但是我自己都不炒这些股,因为觉得太多都是luck了。
我仔细看了文章,减肥药里面就三家,Vivus’ (VVUS) qnexa, Orexigen’s (OREX)
contrave and Arena’s (ARNA) lorcaserin。 前面被否的那两家,都不是新药,是把
已经有的药combine起来。只有这个arna的药,是novel target到蛋白质的receptor上
的新药。
看了FDA之前对他们rat的data的疑问,觉得很正常。因为现在是脑子里面的target,研
究脑子的pk数据,都是用plasma数据估算的。而且还有问题,就是肿瘤模型很复杂,就
算control rat里面,各种肿瘤模型也很复杂。这些确实都是问题,因为FDA审批的时候
,特别按部就班,他们很不容易接受regulation方面新的挑战。
但我现在是觉得这个药还是比较promising的。至少好像efficacy和toxicity都没问题
。我会hold到resubmission.如果这个他们能被接受... 阅读全帖 |
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m*****t 发帖数: 1987 | 31 大概是因为这个吧
Orexigen® Announces Agreement From the FDA on a Special Protocol
Assessment for the Contrave® Outcomes Trial
大牛说说这个药有希望么?记得你以前说不要碰,考虑要不要把手里得出了。谢谢 |
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