Biotech Stocks Facing FDA Approval From Apr - Oct 2010

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http://gwestrookitraders.com/fdadates.html


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-steroidalanti-inflammatory drug in a single tablet, intended to provide painrelief with fewer gastrointestinal side effects. AztraZeneca(AZN) isPozen'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 panelmeeting to review the Provenge application. A similar panel meeting washeld 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 ofpirfenidone 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 willreview the safety and efficacy of Acthar on May 6. The FDA's review ofActhar 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 reviewGilenia. If approved, Gilenia would be the first multiple sclerosisdrug administered as a pill, and as such, the drug could have an impacton 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 withthe way the drug is manufactured. Savient revised the Krystexxamanufacturing process and submitted a response in March to the FDA'scomplete 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-steroidalanti-inflammatory drug (NSAID) marketed in the U.S. as a single agentfor the management of acute moderate-to-severe pain in adults sinceketorolac in 1990. The active ingredient in Dyloject is diclofenacsodium, a widely prescribed oral NSAID. More Dates

Note from : Gwestrookitraders.comThis is not a recommendation to buy or sell in these securities theinformation is presented "as-is" we are not responsible for theaccuracy or effectiveness of this information.

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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.

Arena Pharmaceuticals (ARNA)
Drug/indication: Lorcaserin for obesity
Approval decision date: Oct. 22
Lorcaserin is one of three obesity drugs currently under review by the FDA. Regulators have not yet indicated whether Arena will be required to bring lorcaserin in front of an advisory panel.

Vivus (VVUS)
Drug/indication: Qnexa for obesity
Approval decision date: October 28
The FDA has scheduled an advisory committee meeting on July 15 to review Qnexa's safety and efficacy as a weight-loss drug. The FDA's review of Qnexa will be posted to the agency's web site on July 13 or July 14.

Biodel (BOID)
Drug/indication: VIAject for diabetes
Approval decision date: Oct. 30
VIAject is a fast-acting insulin analogue designed for absorption into the bloodstream that's faster than currently marketed rapid-acting insulin.

Note from : Gwestrookitraders.com
This is not a recommendation to buy or sell in these securities the information is presented "as-is" we are not responsible for the accuracy or effectiveness of this information.

babyice

是建议买吗？英文不太好 :/

葉芬

是建议买吗？英文不太好 :/
babyice 发表于 22-4-2010 12:13 AM

沒建議買賣，只是純粹分享而已。