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pray2008 (stock888) 于 (Sun Apr 11 22:47:41 2010, 美东) 提到:
http://gwestrookitraders.com/fdadates.html
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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 pixantrone.
Pozen (POZN)
Drug/indication: Vimovo for pain relief
Approval decision date: April 30
Vimovo combines an acid inhibitor with a non-steroidal anti-inflammatory
drug in a single tablet, intended to provide pain relief with fewer
gastrointestinal side effects. AztraZeneca(AZN) is Pozen's marketing partner
for Vimovo.
Dendreon (DNDN)
Drug/indication: Provenge for prostate cancer
Approval decision date: May 1
The FDA has given no indication that it plans to hold an advisory panel
meeting to review the Provenge application. A similar panel meeting was held
in 2007, which voted to recommend the drug's approval.
InterMune (ITMN)
Drug/indication: Pirfenidone for idiopathic pulmonary fibrosis
Approval decision date: May 4
An FDA advisory panel held March 9 voted to recommend the approval of
pirfenidone for the treatment of idiopathic pulmonary fibrosis.
Questcor Pharmaceuticals (QCOR)
Drug/indication: Acthar for infantile spasms
Approval decision date: June 11
Prior to the FDA's approval decision date, an FDA advisory panel will review
the safety and efficacy of Acthar on May 6. The FDA's review of Acthar is
expected to post to the agency's web site on May 4 or May 5.
Novartis (NVS)
Drug/indication: Gilenia for multiple sclerosis
Approval decision date: June 2010 (Novartis has not disclosed the exact date
.)
The FDA is holding an advisory committee meeting on June 10 to review
Gilenia. If approved, Gilenia would be the first multiple sclerosis drug
administered as a pill, and as such, the drug could have an impact on
already approved, injectable MS drugs from Biogen Idec(BIIB), Teva(TEVA) and
Merck-Serono.
Savient Pharmaceuticals (SVNT)
Drug/indication: Krystexxa for gout
Approval decision date: Sept. 14
The FDA refused to approve Krystexxa last August, citing problems with the
way the drug is manufactured. Savient revised the Krystexxa manufacturing
process and submitted a response in March to the FDA's complete response
letter.
Javelin Pharmaceuticals (JAV)
Drug/indication: Dyloject for acute moderate-to-severe pain in adults
Approval decision date: Oct. 3
If approved, Dyloject will be the first IV non-steroidal anti-inflammatory
drug (NSAID) marketed in the U.S. as a single agent for the management of
acute moderate-to-severe pain in adults since ketorolac in 1990. The active
ingredient in Dyloject is diclofenac sodium, a widely prescribed oral NSAID.
More Dates
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pray2008 (stock888) 于 (Mon Apr 12 10:13:16 2010, 美东) 提到:
next page:
Human Genome Sciences (HGSI) Drug/indication: Zalbin for hepatitis C
Approval decision date: Oct. 4
Zalbin is a longer-acting formulation of interferon that can be dosed as
infrequently as every two weeks for the treatment of hepatitis C. Currently
approved long-acting interferons required once-weekly dosing.
Alexza Pharmaceuticals
(ALXA) Drug/indication: AZ-004 for agitation in patients with schizophrenia
or bipolar disorder
Approval decision date: Oct. 11
AZ-004 is an inhaled formulation of the generic antispsychotic drug loxapine
, intended for the rapid treatment of adults with schizophrenia or bipolar
disorder. Biovail(BVF) will market AZ-004 in the U.S. and Canada, if
approved
Jazz Pharmaceuticals (JAZZ)
Drug/indication: JZP-6 for fibromyalgia
Approval decision date: Oct. 11
JZP-6 contains the same active ingredient as Xyrem, which Jazz currently
markets in the U.S. as a treatment for excessive daytime sleepiness and
cataplexy in adult patients with narcolepsy. |
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