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发帖数: 5997 | 1 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 panels is also included.
Regeneron Pharmaceuticals(REGN_)
Drug/indication: Eyelea (VEGF Trap-Eye) for wet age-related macular degeneration
Approval decision date: Aug. 19, 2011
An FDA advisory panel in June voted to recommend Eyelea's approval.
Dendreon(DNDN_)
Drug/indication: Provenge for prostate cancer (Atlanta manufacturing expansion)
Approval decision date: Aug. 28, 2011
NuPathe(PATH_)
Drug/indication: Zelrix, a skin patch for migraines.
Approval decision date: Aug. 29, 2011
Seattle Genetics(SGEN_)
Drug/indication: Adcetris for Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL)
Approval decision date: Aug. 30, 2011
Alexion Pharmaceuticals(ALXN_)
Drug/indication: Soliris for Hemolytic Uremic Syndrome (HUS)
Approval decision date: Oct. 7, 2011
This would be the second approved indication for Soliris, which is already marketed as a treatment for paroxysymal nocturnal hemoglobinuria (PNH).
Bristol-Myers Squibb and AstraZeneca
Drug/indication: dapagliflozin for diabetes
Approval decision date: Oct. 28, 2011
An FDA advisory panel on July 19 voted to recommend against approval of dapagliflozin.
Pacira Pharmaceuticals(PCRX_)
Drug/indication: Exparel for post-surgical pain management
Approval decision date: Oct. 28, 2011
Roche(RHHBY)
Drug/indication: Zelboraf for melanoma
Approval decision date: Oct. 28, 2011
Alimera Sciences(ALIM_)
Drug/indication: Iluvien for diabetic
Approval decision date: Nov. 11, 2011
Teva Pharmaceuticals(TEVA_) and BioSante Pharmaceuticals(BPAX_)
Drug/indication: Bio-T-Gel for male low testosterone levels
Approval decision date: Nov. 14, 2011
Spectrum Pharmaceuticals(SPPI_)
Drug/indication: Zevalin for non-Hodgkin's lymphoma (removal of Bioscan requirement)
Approval decision date: Nov. 20, 2011
Incyte(INCY_) and Novartis(NVS_)
Drug/indication: Ruxolitinib for myelofibrosis
Approval decision date: Dec. 3, 2011
Antares Pharma(AIS_)
Drug/indication: Anturol for overactive bladder
Approval decision date: Dec. 8, 2011
Pfizer
Drug/indication: crizotinib for non-small cell lung cancer
Approval decision date: Before end of 2011
Amylin Pharmaceuticals(AMLN_), Eli Lilly>(LLY_) and Alkermes>(ALKS_)
Drug/indication: Bydureon for diabetes
Approval decision date: Jan. 28, 2012
Alexza Pharmaceuticals(ALXA_)
Drug/indication: AZ-004 for schizophrenia-induced agitation
Approval decision date: Feb. 3, 2012
Corcept Therapeutics(CORT_)
Drug/indication: Corlux for Cushing's Syndrome
Approval decision date: Feb. 17, 2012
MAP Pharmaceuticals(MAPP_)
Drug/indication: Levadex for migraine
Approval decision date: March 26, 2012
Affymax(AFFY_) and Takeda
Drug/indication: peginesatide for anemia associated with chronic kidney disease
Approval decision date: March 27, 2012
Source: BioMedTracker, TheStreet research, company reports.
--Written by Adam Feuerstein in Boston. | y*****l
发帖数: 5997 | 2 http://www.thestreet.com/story/11264599/1/biotech-calendar-key-
Biotech Calendar: Key Dates for October
By Adam Feuerstein 10/03/11 - 08:18 AM EDT
3 CommentsAdd CommentStock quotes in this article:AMGN, PCRX, BIIB, EXEL,
RIGL, DVAX, ONXX inShare.0BOSTON, Mass. (TheStreet) -- A calendar of
important, potentially stock-moving biotech events for October:
Oct. 1-5
Obesity Society annual meeting.
Oct. 3
Onyx Pharmaceuticals(ONXX_) v. Bayer flurosorafenib litigation gets underway
.
Oct. 5
Research abstracts for the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) annual meeting made available.
Oct. 6
"Cancer Immunotherapy: A Long-Awaited Reality" conference, sponsored by MD
Becker Partners.
Oct. 11-15
American Society for Human Genetics (ASHG) meeting.
Oct. 13
Rigel Pharmaceuticals(RIGL_) investor/analyst meeting: Asthma strategy and
pipeline.
Oct. 19-21
ECTRIMS annual meeting. Key data presentations include Teva's(TEVA_)
laquinimod and Biogen Idec's(BIIB_) BG-12.
Oct. 20-23
Infectious Disease Society of America (IDSA) meeting. Dynavax Technologies(
DVAX_) Heplisav Hepatitis B data to be presented.
Oct 22-25
American Academy of Opthalmology (AAO) meeting.
Oct. 24
Amgen(AMGN_) third-quarter earnings.
Oct. 28
FDA approval decision for Pacira Pharmaceuticals'(PCRX_) Exparel for post-
surgical pain management.
FDA approval decision date for Bristol-Myers Squibb(BMY_) and AstraZeneca's(
AZN_) dapagliflozin for diabetes. An FDA advisory panel on July 19 voted to
recommend against approval.
Biotech events expected before the end of September:
Biogen Idec: Top-line results of a phase III study of the multiple sclerosis
drug BG-12 compared against Teva's Copaxone.
Exelixis(EXEL_): Top-line results of phase III study of cabozantinib in
medullary thyroid cancer.
Sources: TheStreet research, company announcements, BioMedTracker
--Written by Adam Feuerstein in Boston. |
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