发帖数: 1 | 1 J&J, AbbVie's Imbruvica breaks into larger CLL market with first-line FDA
nod
March 4, 2016
Johnson & Johnson and AbbVie have snagged the indication for standout cancer
med Imbruvica that they've been waiting for.
On Friday, the FDA granted the pair a first-line nod in chronic lymphocytic
leukemia (CLL) based on results of a Phase III trial in which the med cut
the risk of disease progression or death by 84% compared with chemo
treatment chlorambucil.
It's a win for the companies, which already ... 阅读全帖 |
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m*******a
发帖数: 8 | 2 yes, thalidomide has been approved for years for treatment of multiple
myeloma and erythema nodosum leprosum, and i remember reading it can be used
off-label for MDS too |
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I****a
发帖数: 407 | 3 I might disagree. Giving steroid for suspected multiple myeloma/lymphoma may
sometimes jeopardize the yield of future definitive tissue diagnosis. She
has so much extra nodal disease burden so I won't be surprised if her GI
tract is also involved.
and |
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I****a
发帖数: 407 | 4 I might disagree. Giving steroid for suspected multiple myeloma/lymphoma may
sometimes jeopardize the yield of future definitive tissue diagnosis. She
has so much extra nodal disease burden so I won't be surprised if her GI
tract is also involved.
and |
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I****a
发帖数: 407 | 5 You are welcome. The next couple years will be very excited for Late stage
prostate cancer treatment, much like multiple myeloma story in the past
decade. |
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I****a
发帖数: 407 | 6 You are welcome. The next couple years will be very excited for Late stage
prostate cancer treatment, much like multiple myeloma story in the past
decade. |
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M****a
发帖数: 577 | 7 病人像是有raccoon eyes，外科是颅底骨折（他耳朵后面有没有瘀斑？），内科是
amyloidosis, multiple myeloma, neuroblastoma, cocaine...
病史里有没有可以往上面靠的？ |
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s*****e
发帖数: 404 | 8 An old man with pancytopenia need to consider MDS, lymphoma, multiple
myeloma, or leukemia, if iron, folate, vitamin B12, or copper deficiency are
excluded.
He has pancytopenia with neutropenia, concerning for hematological
malignancy. I think he needs to have LDH, uric acid, peripheral smear, SPEP,
UPEP and ultimately a bone marrow biopsy. |
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h*****8
发帖数: 4754 | 9 Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the
Treatment of Refractory Advanced Colorectal Cancer
NEW YORK, April 5 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (
Nasdaq: KERX) today announced that the U.S. Food and Drug Administration (
FDA) has granted Fast Track designation for KRX-0401 (perifosine), the
Company's novel, potentially first-in-class, oral anti-cancer agent that
inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for
... 阅读全帖 |
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h*****8
发帖数: 4754 | 10 NND,前几天加的居然入水这么久。
announced
a
demonstrated |
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t*******o
发帖数: 1464 | 12 EXEL June5-7
Presentations Featuring XL184 (MET, VEGF, RET)
* Oral presentation: Data from a phase 2 study of XL184 in patients with
progressive glioblastoma will be presented on Saturday, June 5, 2010 from 5
* Oral presentation: Long-term results in a cohort of medullary thyroid
cancer patients in a phase 1 study of XL184 will be presented in a clinical
science symposium on Monday, June 7 at 10:45-11:00AM (Abstract #5502).
* Poster discussion: Data from a phase 1b/2 study of XL184 ... 阅读全帖 |
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h*****8
发帖数: 4754 | 13 AEZS是个加拿大的BIO-TECH公司。做Oncology和Endocrinology方面的药物研制。
有一个药在市场上：Cetrotide。
2个3期的药：
第一个是Perifosine,用于Multiple myeloma和 Colorectal cancer.这个是和 KERX合
作的。FDA granted orphan-drug and fast track designation. 这个东西好像在欧洲
也是有Orphan medical product designation.和KERX的partner 限于北美。
第二个是AEZS-130，Diagnostic in adult growth hormone deficiency 也拿到了
Orphan-drug designation.
2个2期的：
Perifosine，用于别的癌症。
AEZS-108： Ovarian Cancer和Endometrial Caner.
还有几个一期的和Pre-clinical Trials.
总体来讲，公司应该有研有发，基本面不坏。
不属于那种挂在单一药，结果不好，直接死掉的。
... 阅读全帖 |
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g**********1
发帖数: 399 | 14 it's for myeloma, nothing compared to their major drug |
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b*****h
发帖数: 783 | 15 看来是positive result。
KERX 在2011年会release,
1. zerenex 的52-week long term result.
2. phase 3 clinical trial of KRX-0401 treating patients with advanced
multiple myeloma.
3. Phase 3 clinical trial of KRX-0401 treating patients with refractory advanced
colorectal cancer |
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y*****l
发帖数: 5997 | 16 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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v**********m
发帖数: 5516 | 17 KRX-0401 (perifosine)
Multiple myeloma
Phase 3 ongoing, under SPA
Colorectal cancer
Phase 3 ongoing, under SPA
Multiple other forms of cancer
Phase 2 trials ongoing
ZerenexTM (ferric citrate)
Hyperphosphatemia in patients with end-stage renal disease
U.S. Phase 3 program ongoing under SPA;
Japan Phase 3 program ongoing by sublicensee (JT and Torii)
这些实验结果什么时候会出来？ |
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w*********7
发帖数: 2883 | 18 【 以下文字转载自 JQCLUB 俱乐部 】
发信人: winnie91107 (爱的承诺), 信区: JQCLUB
标 题: ISIS
发信站: BBS 未名空间站 (Fri Aug 5 13:32:08 2011, 美东)
Isis Reports Financial Results and Highlights for Second Quarter 2011
21 hours 30 minutes ago - PR Newswire via Comtex
PR Newswire
Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) today announced its financial
results for the quarter ended June 30, 2011. The Company finished the second
quarter of 2011 with a pro forma net operating loss (NOL) of $11.6 million
and $24.9 million for the thr... 阅读全帖 |
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p********e
发帖数: 1960 | 19 DNDN, KERX, BPAX, CHTP, OPXA
http://seekingalpha.com/article/286963-5-cheap-biotech-stocks-t
Most biotech stocks have experienced very sharp drops as the markets have
plummeted over economic concerns. However, biotechs are not as economically
sensitive as other companies and therefore are likely to rebound sharply in
the coming days. These dirt cheap biotech companies all have interesting
products in the pipeline which could become major catalysts in the future.
The lower priced stocks tend to h... 阅读全帖 |
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y*****l
发帖数: 5997 | 20 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*****9
发帖数: 43 | 21 感谢版主邀请，既然进来了，怎么也得贡献一点心得。这个就再这里首发了~~
这两个股票目前都还是低价股，但是都属于同一类股票。都是与血液肿瘤（癌症）相关
的BIO公司。
医药股的特点不是EPS，不是REV，（当然这些仍是成熟BIO的特点）对于研发阶段的BIO
，最重要的是它的实验数据（trial data).每次关键的data公布都会成为股价的催化剂。
SNTA: 最近两日的大涨都源自于本月底前后的data
Preliminary results from the GALAXY trial are expected in the second quarter
of 2012, and additional results from the GALAXY trial together with
preliminary results from the ALK+ lung cancer and breast cancer trials are
expected in the second half of 2012. In addition to the company-sponsored
tr... 阅读全帖 |
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E****e
发帖数: 315 | 22 from SeekingAlpha
The recent news announcing Genentech’s (DNA) receipt of a “Refuse to File
(RTF)” letter from the FDA for the accelerated approval of the Biologic
License Application (BLA) for trastuzumab-DM1 (T-DM1) has caused a sell-off
in Immunogen, the owner of the technology and partner on the drug with Roche
. According to the FDA letter, the refusal to give the early approval was
because “the trials had not yet exhausted all available drugs approved for
metastatic breast cancer, regardle... 阅读全帖 |
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E****e
发帖数: 315 | 23 from SeekingAlpha
The recent news announcing Genentech’s (DNA) receipt of a “Refuse to File
(RTF)” letter from the FDA for the accelerated approval of the Biologic
License Application (BLA) for trastuzumab-DM1 (T-DM1) has caused a sell-off
in Immunogen, the owner of the technology and partner on the drug with Roche
. According to the FDA letter, the refusal to give the early approval was
because “the trials had not yet exhausted all available drugs approved for
metastatic breast cancer, regardle... 阅读全帖 |
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m****g
发帖数: 530 | 24 SEATTLE, March 23 /PRNewswire-FirstCall/ -- Oncothyreon Inc. (NASDAQ:ONTY)
today announced that
Merck Serono, a division of Merck KGaA of Darmstadt, Germany, and its U.S.
affiliate, EMD Serono, Inc.,
have temporarily suspended the worldwide clinical development program for
Stimuvax(R) (BLP25 liposomal
vaccine). The suspension is the result of a suspected unexpected serious
adverse reaction in a patient with
multiple myeloma participating in an exploratory clinical trial. This
decision was taken |
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y***y
发帖数: 4957 | 25 【 以下文字转载自 NextGeneration 讨论区 】
发信人: ILoveMyMom (我也爱宝宝), 信区: NextGeneration
标 题: 为我亲爱的妈妈求祝福！！
发信站: BBS 未名空间站 (Fri Feb 13 11:52:00 2009)
几天前的早上，我们很高兴的得知我怀孕了，这是我们盼望了好几个月的宝宝。可是在
我们才刚刚高兴了几个小时后，我得知我亲爱的妈妈得了“骨髓多发性肿瘤（multiple
myeloma）”，一种骨髓癌。妈妈的具体病情我发在medicine版，希望有专家可以帮着
看看。
http://www.mitbbs.com/article_t/Medicine/31181365.html
一下子不知道该怎么办，妈妈一辈子劳碌，希望她能安享晚年。妈妈一辈子有很多的不
幸，十几年前，爸爸在一次意外的事故中去世，我和妈妈一直是相依为命。但是我妈妈
是个很坚强的妈妈，从来都是那样勇敢地面对生活中的不幸。我妈很善良，很开朗，很
知道为着生命中的点点滴滴感谢上帝。我已经很多天没有睡好觉了，同时情绪也不是很
稳定。真的也担心对腹中的胎儿不好。
都说宝 |
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