t******g
发帖数: 462 | 1 Amylin Pharmaceuticals Inc., Eli Lilly & Co. and Alkermes Inc. dropped in
early trading after they were rebuffed a second time in a bid to gain
approval of a once-weekly version of the diabetes drug Byetta.
The Food and Drug Administration “blindsided” the companies late yesterday
by calling for a study assessing the heart risks for the new drug Bydureon,
said Phil Nadeau, an analyst with Cowen & Co. in New York.
The FDA restricted the use last month of GlaxoSmithKline Plc’s diabetes
drug Avandi... 阅读全帖 |
|
l******k
发帖数: 27533 | 2 今天试着把玩了下，不好用呀～
优点：
同为exenatide，byetta是BID，bydureon是每周一次。
byetta主要是作用于postprandial 降饭后血糖，而bydureon因为是慢慢释放，所以对
fasting的作用很好,这点很赞！
其他优点还没想到，大家补充吧
缺点：
坑爹的注射呀，要病人用先自己配。有效成分是microphere，粉状，要把液体加到装有
粉状的安瓶中。还要保持瓶内高压，摇晃溶解粉末。这个。。。一般的病人会比较难操
作呀！
新配制的溶液不稳定，现配现用。
针头好粗，23 gauge 呀，说是扎下去可能会肿2个周:(
现在用的人不多，毕竟保险要求很严，但不知道以后会不会推广开来。。。 |
|
l******k
发帖数: 27533 | 3 哈哈，这么爽！
都是exenatide嘛，就是用了新的制剂技术，弄成了microphere
有些保险全cover byetta的，但保险对bydureon要求很多，不容易得到好的coverage |
|
D******9
发帖数: 2665 | 4 Bydureon Gains EU Approval
Print Share
By: Zacks Equity Research
June 22, 2011 |Comments: 0
Recommended this article (0)
LLY | ALKS | AMLN | NVO
Amylin Pharmaceuticals, Inc. (AMLN) and its partners, Eli Lilly and Company
(LLY), and Alkermes, Inc. (ALKS), recently received a boost with the
European Commission granting marketing authorization to Bydureon (exenatide
once-weekly) for the treatment of type II diabetes.
Bydureon is the first once-weekly treatment to gain approval for type II
diabetes.... 阅读全帖 |
|
K********g
发帖数: 9389 | 5 Type 2 Diabetes
Ninety to 95 percent of the estimated 246 million adults worldwide who
suffer from diabetes have type 2 diabetes.(1) Despite the introduction of
new medications over the last decade, many people with diabetes are unable
to control their blood sugar.(2) An extended-release formulation of
exenatide may provide a new treatment option for patients with type 2
diabetes.
New treatment paradigm: BYDUREON™ (exenatide extended-release for
injectable suspension) is an extended-rele... 阅读全帖 |
|
f**********g
发帖数: 2252 | 6 Despite the recent setback with the FDA requesting
additional study on Bydureon, for
which ALKS holds an 8% royalty stake with
minimal cost exposure, we remain positive on
ALKS's prospects to diversify sources of revenue
beyond Risperdal Consta royalties.We
view the market opportunity for recently approved
Vivitrol for opioid dependence as attractive,
given the drug's once monthly formulation
and non-addictive mechanism of action, although
we acknowledge the drug's modest
adoption for treating a... 阅读全帖 |
|
y*****l
发帖数: 5997 | 7 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 |
|
K********g
发帖数: 9389 | 8 ALKS的今天药物VIVITROL专家推荐为批准后，下个月可能两个药会得到FDA审批。除了
今天的VIVITROL外，还有一个药为BYDUREON，用于糖尿病的治疗。
VIVITROL的批准用于治疗药瘾地市场大概有100M-120M，BYDUREON的药物如果批准，那
么市场估计在500-600M（三家合作的，Lily和AMLN），还没有调研ALKS占有多少分量，
但是批准估计没多大问题（FDA并未要求补充新的临床前或临床研究资料。该回复函主
要是关于产品的最终标签，要求附加风险评价和规避方案（REMS），并写明产品目前的
生产过程。）。
现在才把这个拿出来，有点晚了，但是风险也小了，我觉得还有上涨空间。
基本面分析，在等等慢慢写，我要先睡觉了。 |
|
f**********g
发帖数: 2252 | 9 Not sure about its market, but looks like phase 2 did not draw much
attentions.
We project FY 11 (Mar.) and FY 12 revenues of
$174 million and $200 million, respectively.We
expect ALKS's main revenue source to be royalties
on sales and manufacturing of Johnson &
Johnson's Risperdal Consta, which rose 11.5%
in FY 10, to $1.5 billion.We expect near-term results
to fluctuate with foreign exchange volatility
and U.S. health care reform.We have removed
near-term royalties from Bydureon from
our estim... 阅读全帖 |
|
y*****l
发帖数: 5997 | 10 Amylin is set for an FDA decision on its product candidate, Bydureon, on 01/
27/2012. Bydureon a glucagon-like peptide-1 receptor agonist, and would be
the first once-weekly treatment for type 2 diabetes in adults. It delivers
glycemic control in a single weekly dose. AMLN currently trades around $10.
50 with the highest sell-side analyst one year price target being $25. |
|
O**I
发帖数: 776 | 11 【 以下文字转载自 pennystock 俱乐部 】
发信人: OSCI (TX), 信区: pennystock
标 题: FDA Drug Approvals in 2011
发信站: BBS 未名空间站 (Sat Jan 8 17:29:50 2011, 美东)
http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
... 阅读全帖 |
|
r***s
发帖数: 1805 | 12 批了. 小玩了一个 bull spread, 估计挣不了几个钱.
FDA approves Bydureon from Amylin, Alkermes, Bloomberg says |
|
r***s
发帖数: 1805 | 13 批了. 小玩了一个 bull spread, 估计挣不了几个钱.
FDA approves Bydureon from Amylin, Alkermes, Bloomberg says |
|
b*****p
发帖数: 9649 | 14 by http://www.guancha.cn/xiaopengcai
星期五传出来Ariad Pharmaceuticals($ARIA)公司内部董事会开始内斗。目前这家公司
的最大股东是萨瑞莎资本公司（Sarissa Capital）拥有6.9%的股份。自从这家维权对
冲基金公司（Activist Hedge Fund）入主这家公司，市场上就开始有心理准备这场即
将到来震荡。萨瑞莎资本公司的创始人叫Alex Denner，今年45岁，是真正的高富帅啊
。这人麻省理工大学本科毕业，耶鲁大学生物医学工程专业博士，博士毕业后在华尔街
摩根斯坦利（Morgan Stanley）和维京全球投资公司（Viking Global Investors）做
医药和生物科技基金经理，后来拜入卡尔·伊卡恩（Carl Icahn）门下统管医药和生物
科技对冲基金，成为卡尔·伊卡恩门生。这人非常内行专业，很懂得分析生物医药公司
的内在价值并把这种价值体现在商业价值上。2012年羽翼丰满脱离卡尔集团自创萨瑞莎
对冲基金公司。
我在前面2月8日文章“大鱼吃小鱼，小鱼吃虾米”中有提到卡尔·伊卡恩是一个传奇投
资... 阅读全帖 |
|
|
|
b******8
发帖数: 1251 | 17 喔，呵呵，这个，我还去吃了人家的dinner，哈哈，一边吃，一边听，我觉得他们的定
价不错，和byetta差不多，都是300多美元。好处就是一周一次。 |
|
|
|
l******k
发帖数: 27533 | 20 是呀，有syringe and needle
needle短短的，就是粗！ |
|
l******k
发帖数: 27533 | 21 呵呵，是呀
因为是microphere，需要大针头才打得出来吧 |
|
r*******w
发帖数: 197 | 22 谢谢LZ分享新知识，这个药还没见医生开过，估计MCD会COVER吧，感觉MCD啥都COVER,
连VIAGRA都是。 |
|
c****m
发帖数: 626 | 23 上学期听过讲座，没想到这学期就上市了。一个dose卖多少钱？ |
|
t*******o
发帖数: 1464 | 24 http://www.thestreet.com/story/10766153/1/alkermes-vivitrol-gets-speedy-fda-review.html
Alkermes(ALKS) will hear from U.S. drug regulators by Oct. 12 about an
approval decision for the company's drug to treat patients addicted to
opioid painkillers, the company said.
October is shaping up to be busy month for Alkermes. On Oct. 22, the FDA is
also expected to issue an approval decision for Bydureon, the company's long
-acting diabetes drug which is partnered with Amylin Pharmaceuticals and Eli
Li... 阅读全帖 |
|
N***i
发帖数: 2063 | 25 http://www.zacks.com/stock/news/37221/Pharma+and+Biotech+Industry+Outlook+-+July+2010
By: Zacks Equity Research
July 20, 2010 | Comments: 0
Recommended this article (2)
ABT | JNJ | PFE | MRK | RHHBY | BMY | SNY | MYL | LLY | GSK | ACL | GILD |
BIIB | AMLN
Print Share
The pharmaceutical industry has witnessed major changes over the past few
quarters, with performance being affected by factors like sluggish
prescription trends, intensifying generic competition and limited late-stage
catalysts. ... 阅读全帖 |
|
b*****h
发帖数: 783 | 26 AMLN 的revenue 有700＋M, 怎么也值10多块。 |
|
|
r******2
发帖数: 754 | 28 太过分了。居然没看它一眼。ＴＯＴＡＬＬＹ不可能。快买ＬＥＡＰ ＣＡＬＬ |
|
|
|
b*****h
发帖数: 783 | 31 出了吧，这种quick money不能太贪，风险不大，但是上面的上升速度会比较慢。
timing cost不是那么合算。 |
|
O**I
发帖数: 776 | 32 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 |
|
O**I
发帖数: 776 | 33 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 |
|
f**********g
发帖数: 2252 | 34 http://www.thestreet.com/_yahoo/story/10989791/1/biotech-calend
By Adam Feuerstein 01/31/11 - 09:10 AM EST
ALIM, AEN, EXEL, PLX, GENZ, IDIX, AVNR
BOSTON, Mass. (TheStreet) -- A calendar of important, potentially stock-
moving biotech events for February:
More from Adam Feuerstein
NPS Pharma: Gattex Bowel Study SucceedsArena Pharma: Weight-Loss Drug
WoesBiotech Stock Mailbag: Orexigen TherapeuticsMarket Activity
AVANIR Pharmaceuticals| AVNR DOWNAlimera Sciences Inc.| ALIM DOWNProtalix
BioThera... 阅读全帖 |
|
f**********g
发帖数: 2252 | 35 http://www.thestreet.com/_yahoo/story/10989791/1/biotech-calend
By Adam Feuerstein 01/31/11 - 09:10 AM EST
ALIM, AEN, EXEL, PLX, GENZ, IDIX, AVNR
BOSTON, Mass. (TheStreet) -- A calendar of important, potentially stock-
moving biotech events for February:
More from Adam Feuerstein
NPS Pharma: Gattex Bowel Study SucceedsArena Pharma: Weight-Loss Drug
WoesBiotech Stock Mailbag: Orexigen TherapeuticsMarket Activity
AVANIR Pharmaceuticals| AVNR DOWNAlimera Sciences Inc.| ALIM DOWNProtalix
BioThera... 阅读全帖 |
|
w*******0
发帖数: 13 | 36 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 |
|
w*******0
发帖数: 13 | 37 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 |
|
y*****l
发帖数: 5997 | 38 http://www.thestreet.com/story/11016605/1/biotech-calendars-201
By Adam Feuerstein 02/22/11 - 07:36 AM ES
Stock quotes in this article:HGSI, OPTR, XNPT, SPPI, DRRX, PATH
BOSTON (TheStreet) -- I've updated the 2011 FDA drug approval calendar.
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 regul... 阅读全帖 |
|
y*****l
发帖数: 5997 | 39 http://www.thestreet.com/_yahoo/story/11215926/1/biotech-calend
Updated with corrected FDA approval decision date for Roche's melanoma drug
Zelboraf. It's Oct. 28, 2011, not Nov. 11, 2011, as previously reported.
BOSTON (TheStreet) -- The 2011 FDA drug approval calendar has been updated
and extended through the first quarter of 2012.
For easier reference, this regulatory calendar is organized in chronological
order based on the drug approval decision date. Information on pending FDA
advisory pan... 阅读全帖 |
|
y*****l
发帖数: 5997 | 40 11:55 Do you think there is > 50% chance someone buys HGSI in next 12 mos.?
Yes
( 68% )No
( 32% )
Thursday October 20, 2011 11:55
11:56 adam feuerstein: Hello! Welcome to the October edition of Biotech
Stock Live Chat.
Thursday October 20, 2011 11:56 adam feuerstein
12:02 adam feuerstein: hi everyone
Thursday October 20, 2011 12:02 adam feuerstein
12:02 adam feuerstein: I'll get started in a minute or so, let folks log in
.
Thursday October 20, 2011 12:02 adam feuerstein
12:02 adam feuers... 阅读全帖 |
|
b*****h
发帖数: 783 | 41 amln 的BYDUREON 和NVO 的Victoza head to head 对比试验输掉了,就注定amln 会失
宠。 |
|
D******9
发帖数: 2665 | 42 个人认为FDA会批准BYDUREON， 欧洲已经批准了， FDA要求的心率不齐的实验已经完成
， 没有问题。 唯一的问题是现在市场上已经有很多种治疗二型糖尿病的药， 不知道
能导致公司盈利。。。要是批准， 能50% UP, 要是有大药厂有兴趣买， 能DOUBLE |
|
