m****g
发帖数: 530 | 1 PR Newswire US - Jul. 29, 2009
SEATTLE, July 29 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. announced
today that it was notified by
the European Medicines Agency that pixantrone is eligible to be submitted
for a MAA through the EMEA's
centralized procedure. CTI completed the submission of the NDA to the FDA
for pixantrone to treat relapsed
or refractory, aggressive NHL in June 2009 and requested priority review,
which if granted could lead to an
approval decision from the FDA in the fourth |
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e*n
发帖数: 1511 | 3 Italian Medicines Agency Approves NerPharMa to Manufacture Cell Therapeutics
' Drug Pixantrone in European Union
SEATTLE, June 14 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (
Nasdaq and MTA: CTIC) today announced that the Italian Medicines Agency ("
AIFA"), the national authority responsible for drug regulation in Italy, has
approved the facility at NerPharMa DS (a pharmaceutical manufacturing
company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for
the producti... 阅读全帖 |
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w****a
发帖数: 12 | 4 Biotech Calendar: 2011 FDA Drug Approvals
05/25/11
BOSTON (TheStreet) -- The 2011 FDA drug approval calendar has been updated.
For easier reference, this regulatory calendar is organized in chronological
order based on the drug approval decision date. Information on pending FDA
advisory panels is also included.
Optimer Pharmaceuticals(OPTR_)
Drug/indication: Dificid for Clostridium difficile infection
FDA approval decision date: May 30, 2011
GlaxoSmithKline(GSK_) and Valeant Pharmaceuticals(VRX_... 阅读全帖 |
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d******8
发帖数: 1972 | 6 http://www.thestreet.com/story/11351242/1/10-biotech-stock-pred
BOSTON (TheStreet) -- Ten biotech predictions for 2012:
1. The Amgen(AMGN_) strategy of returning cash to shareholders in form of
share buybacks, Dutch tender offers and dividends is abandoned in favor of
ramped up acquisitions i.e. Gilead Sciences(GILD_) buying Pharmasset(VRUS_).
Large-cap biotech firms start acting like Big Pharma -- choosing to buy
growth instead of seeking it from internal drug development.
2. After much wrangli... 阅读全帖 |
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O**I
发帖数: 776 | 7 【 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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r***e
发帖数: 653 | 8 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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p**********r
发帖数: 108 | 9 ☆─────────────────────────────────────☆
pray2008 (stock888) 于 (Sun Apr 11 22:47:41 2010, 美东) 提到:
http://gwestrookitraders.com/fdadates.html
☆─────────────────────────────────────☆
tanmaomao (坛猫猫) 于 (Mon Apr 12 10:03:52 2010, 美东) 提到:
Biotech Stocks Facing FDA Approval From April - October 2010
Cell Therapeutics (CTIC)
Drug/indication: Pixantrone for non-Hod1gkin's lymphoma
Approval decision date: April 23
An FDA advisory panel held on March 22 voted 9-0 to recommend against
approval of ... 阅读全帖 |
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O**I
发帖数: 776 | 10 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 | 11 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 | 12 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 | 13 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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y*****l
发帖数: 5997 | 14 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 |
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y*****l
发帖数: 5997 | 15 http://www.thestreet.com/story/11131722/1/biotech-calendar-2011
Biotech Calendar: 2011 FDA Drug Approvals
By Adam Feuerstein 05/25/11
BOSTON (TheStreet) -- The 2011 FDA drug approval calendar has been updated.
For easier reference, this regulatory calendar is organized in chronological order based on the drug approval decision date. Information on pending FDA advisory panels is also included.
Optimer Pharmaceuticals(OPTR_)
Drug/indication: Dificid for Clostridium difficile infection
FDA approval... 阅读全帖 |
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y*****l
发帖数: 5997 | 16 http://www.thestreet.com/story/11131722/1/biotech-calendar-2011
Stock quotes in this article:SPPI, CTIC, TSPT, SGEN, ANX, PATH, OPTR
http://finviz.com/screener.ashx?v=341&t=SPPI,CTICD,TSPT,SGEN,AN
Biotech Calendar: 2011 FDA Drug Approvals
By Adam Feuerstein 05/25/11
BOSTON (TheStreet) -- The 2011 FDA drug approval calendar has been updated.
For easier reference, this regulatory calendar is organized in chronological
order based on the drug approval decision date. Information on pending FDA
advis... 阅读全帖 |
|
v**********m
发帖数: 5516 | 17 Cell Therapeutics(CTIC)
Drug/indication: Pixantrone for aggressive non-Hodgkin's lymphoma
Approval decision date: June 2011
Cell Therapeutics filed an appeal with FDA contesting the agency's April
2010 rejection of pixantrone. |
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y*****l
发帖数: 5997 | 18 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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L********3
发帖数: 2272 | 19 Italian Medicines Agency Approves NerPharMa to Manufacture Cell Therapeutics
' Drug Pixantrone in European Union |
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