Friday, February 15, 2013

2013 FDA Drug Approval Decision Calendar


2013 FDA Drug Approval Decision Calendar

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Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.
Johnson & Johnson(JNJ_)
Drug/indication: Canagliflozin for diabetes.
FDA advisory panel: Jan. 10
Approval decision date: March 29
Theravance(THRX_)
Drug/indication: Vibativ for hospital acquired pneumonia
Approval decision date: Jan. 11Santarus(SNTS_)
Drug/indication: Uceris for ulcerative colitis
Approval decision date: Jan. 16NuPathe(PATH_)
Drug/indication: Zelrix for migraine
Approval decision date: Jan. 17, 2013Impax Labs(IPXL_)
Drug/indication: IPX066 for Parkinson's disease
Approval decision date: Jan. 21Hyperion Therapeutics(HPTX_)
Drug/indication: Ravicti for urea cycle disorder
Approval decision date: Jan. 23Sanofi(SNY_) and Isis Pharmaceuticals(ISIS_)
Drug/indication: Kynamro for dyslipidemia/hypercholesterolemia
Approval decision date: Jan. 29, 2013Raptor Pharmaceutical(RPTP_)
Drug/indication: RP103 for cystinosis
Approval decision date: Jan. 30, 2013Hemispherx Biopharma(HEB_)
Drug/indication: Ampligen for chronic fatigue syndrome
Approval decision date: Feb. 1, 2013Celgene(CELG_)
Drug/indication: Pomalidomide for multiple myeloma
Approval decision date: Feb. 8, 2013Dynavax(DVAX_)
Drug/indication: Heplisav for hepatitis B prevention
Approval decision date: Feb. 22, 2013Roche(RHHBY) and Immunogen(IMGN_)
Drug/indication: T-DM1 for breast cancer
Approval decision date Feb. 26Zogenix(ZGNX_)
Drug/indication: Zohydro for chronic pain
Approval decision date: March 1, 2013Depomed(DEPO_)
Drug/indication: Serada for menopause
FDA advisory panel: March 4
Approval decision date: May 31Bristol-Myers Squibb(BMY_)
Drug/indication: Eliquis for blood clot prevention
Approval decision date: March 15A.P. Pharma(APPA_)
Drug/indication: APF530 for chemotherapy induced nausea
Approval decision date: March 27Biogen Idec(BIIB_)
Drug/indication: BG-12 for multiple sclerosis
Approval decision date: March 28MAP Pharma(MAPP_)
Drug/indication: Levadex for migraine
Approval decision date: April 15Sucampo Pharmaceuticals(SCMP_)
Drug/indication: Amitzia for opioid-induced constipation
Approval decision date: April 26Navidea Biopharmaceuticals(NAVB_)
Drug/indication: Lymphoseek, a radioactive tracing agent for lymph node mapping
Approval decision date: April 30GlaxoSmithKline(GSK_)
Drug/indication: Dabrefenib for melanoma
FDA advisory panel: June 3Delcath Systems(DCTH_)
Drug/indication: ChemoSat for liver metastases due to ocular melanoma
Approval decision date: June 14AVEO Pharmaceuticals(AVEO_)
Drug/indication: Tivozanib for kidney cancer
Approval decision date: July 28Companies with drugs filed to FDA but no assigned approval decision dates:Auxillium Pharmaceuticals(AUXL_): Xiaflex for Peyronie's disease
Bayer and Algeta: Alpharadin for prostate cancer
Antares Pharma(ATRS_): Otrexup for rheumatoid arthritis
GlaxoSmithKline: Dolutegravir for HIVSources: Company reports, TheStreet research, BioMedTracker --Written by Adam Feuerstein in Boston.

Friday, December 16, 2011

2013 FDA Expected Approvals!!


2013 FDA Drug Approval Decision Calendar

Please help keeping this post updated by clicking on some ads...


Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.
Johnson & Johnson(JNJ_)
Drug/indication: Canagliflozin for diabetes.
FDA advisory panel: Jan. 10
Approval decision date: March 29
Theravance(THRX_)
Drug/indication: Vibativ for hospital acquired pneumonia
Approval decision date: Jan. 11Santarus(SNTS_)
Drug/indication: Uceris for ulcerative colitis
Approval decision date: Jan. 16NuPathe(PATH_)
Drug/indication: Zelrix for migraine
Approval decision date: Jan. 17, 2013Impax Labs(IPXL_)
Drug/indication: IPX066 for Parkinson's disease
Approval decision date: Jan. 21Hyperion Therapeutics(HPTX_)
Drug/indication: Ravicti for urea cycle disorder
Approval decision date: Jan. 23Sanofi(SNY_) and Isis Pharmaceuticals(ISIS_)
Drug/indication: Kynamro for dyslipidemia/hypercholesterolemia
Approval decision date: Jan. 29, 2013Raptor Pharmaceutical(RPTP_)
Drug/indication: RP103 for cystinosis
Approval decision date: Jan. 30, 2013Hemispherx Biopharma(HEB_)
Drug/indication: Ampligen for chronic fatigue syndrome
Approval decision date: Feb. 1, 2013Celgene(CELG_)
Drug/indication: Pomalidomide for multiple myeloma
Approval decision date: Feb. 8, 2013Dynavax(DVAX_)
Drug/indication: Heplisav for hepatitis B prevention
Approval decision date: Feb. 22, 2013Roche(RHHBY) and Immunogen(IMGN_)
Drug/indication: T-DM1 for breast cancer
Approval decision date Feb. 26Zogenix(ZGNX_)
Drug/indication: Zohydro for chronic pain
Approval decision date: March 1, 2013Depomed(DEPO_)
Drug/indication: Serada for menopause
FDA advisory panel: March 4
Approval decision date: May 31Bristol-Myers Squibb(BMY_)
Drug/indication: Eliquis for blood clot prevention
Approval decision date: March 15A.P. Pharma(APPA_)
Drug/indication: APF530 for chemotherapy induced nausea
Approval decision date: March 27Biogen Idec(BIIB_)
Drug/indication: BG-12 for multiple sclerosis
Approval decision date: March 28MAP Pharma(MAPP_)
Drug/indication: Levadex for migraine
Approval decision date: April 15Sucampo Pharmaceuticals(SCMP_)
Drug/indication: Amitzia for opioid-induced constipation
Approval decision date: April 26Navidea Biopharmaceuticals(NAVB_)
Drug/indication: Lymphoseek, a radioactive tracing agent for lymph node mapping
Approval decision date: April 30GlaxoSmithKline(GSK_)
Drug/indication: Dabrefenib for melanoma
FDA advisory panel: June 3Delcath Systems(DCTH_)
Drug/indication: ChemoSat for liver metastases due to ocular melanoma
Approval decision date: June 14AVEO Pharmaceuticals(AVEO_)
Drug/indication: Tivozanib for kidney cancer
Approval decision date: July 28Companies with drugs filed to FDA but no assigned approval decision dates:Auxillium Pharmaceuticals(AUXL_): Xiaflex for Peyronie's disease
Bayer and Algeta: Alpharadin for prostate cancer
Antares Pharma(ATRS_): Otrexup for rheumatoid arthritis
GlaxoSmithKline: Dolutegravir for HIVSources: Company reports, TheStreet research, BioMedTracker --Written by Adam Feuerstein in Boston.
















2012 FDA Expected Approvals!!

Please help keeping this post acive by clicking on some ads...

Affymax(AFFY_)
Drug/indication:peginesatide for anemia in kidney dialysis patients.
FDA advisory panel: Dec. 7, 2011
Approval decision date:March 27, 2012
Peginesatide, injected once monthly, aims to compete against Amgen's
(AMGN_) Epogen ($2.5 billion in 2010 sales) as a treatment for anemia in patients with chronic kidney disease, although peginesatide use would be limited to sicker kidney dialysis patients only. Amgen recently signed long-term Epogen supply contracts with the two largest kidney dialysis clinics in the U.S.
Pfizer(PFE_)
Drug/indication:Inlyta (axitinib) for kidney cancer
FDA advisory panel: Dec. 7, 2011
Approval decision date: Feb-April 2012
Alexza Pharmaceuticals(ALXA)
Drug/indication:Adasuve for agitation related to schizophrenia
FDA advisory panel: Dec. 12, 2011
Approval decision date: Feb. 4, 2012
Adasuve uses Alexza's proprietary Staccato inhaler system to deliver the anti-agitation medicine loxapine directly into the lungs where it gets into the bloodstream and begins to work quickly. The FDA advisory panel is expected to focus much of its attention on the potential side effects and safety issues related to delivering Adasuve into patients' lungs.
FDA initially rejected Adasuve in October 2010 due to concerns over lung safety. Alexza resubmitted the drug to FDA last August.
Vivus(VVUS), Arena Pharmaceuticals(ARNA_) and Orexigen Therapeutics(OREX_)
Drugs/indication: Qnexa, lorcaserin and Contrave for obesity.
FDA advisory panel: First quarter 2012 (exact date not yet disclosed.)
FDA held advisory panels to review all three of these controversial weight-loss drugs in 2010. FDA subsequently rejected all three drugs. In 2012, Vivus and its obesity drug competitors are back for another shot, and FDA will once again bring together a group of outside experts to weigh the pros and cons of treating obesity with a pill.
Biogen Idec(BIIB_) and Elan (ELN_)
Drug/indication:Update to the Tysabri prescribing label
Approval decision date: Jan. 20, 2012
The Tysabri label update will include information about the anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML). Doctors can use to test to determine which multiple sclerosis patients are at low or high risk for PML, a serious, potentially fatal brain infection caused by Tysabri.
Columbia Labs(CBRX_) and Watson Pharmaceuticals(WPI_)
Drug/indication:progesterone vaginal gel for risk reduction of preterm birth.
FDA advisory panel: Jan. 20, 2012
Approval decision date:Feb. 26, 2012
Amylin Pharmaceuticals(AMLN_)
Drug/indication: Bydureon for diabetes
Approval decision date: Jan. 27, 2012
This is the second shot at approval for Bydureon, a once-weekly injectable medicine for the treatment of Type 2 diabetes. Amylin recently split with its long-time marketing partner Eli Lilly
(LLY_). Alkermes(ALKS_) retains its royalty split on Bydureon sales.
Bristol-Myers Squibb(BMY_)
Drug/indication: dapagliflozin for diabetes
Approval decision date: Jan. 27, 2012
Pfizer(PFE_) and Protalix Biotherapeutics(PLX_)
Drug/indication: Uplyso for Gaucher's disease.
Approval decision date: Feb. 1, 2012
FDA has twice-rejected Uplyso due to manufacturing and quality control issues. If approved this time around, Uplyso will compete against Sanofi/Genzyme's
(SNY_) Cerezyme and Shire's Vpriv.
Teva(TEVA_) and BioSante Pharmaceuticals(BPAX_)
Drug/indication: Bio-T-Gel for hypogonadism
Approval decision date: Feb. 14, 2012
Bio-T-Gel is a once-daily gel used to treat low testosterone in men.
Corcept Pharmaceuticals(CORT_)
Drug/indication: Corlux for Cushing's Syndrome.
Approval decision date: Feb. 17, 2012
FDA will not convene an advisory panel to review Corlux.
Discovery Labs(DSCO_)
Drug/indication: Surfaxin for respiratory distress syndrome in premature infants.
Approval decision date: March 6, 2012
This is Discovery's fifth attempt at convincing FDA to approve Surfaxin.
Roche(RHHBY) and Curis(CRIS_)
Drug/indication: Vismodegib for advanced basal cell carcinoma.
Approval decision date: March 8, 2012.
MAP Pharmaceuticals(MAPP_)
Drug/indication: Levadex for migraines
Approval decision date: March 26, 2012
Levadex is an inhaled migraine drug. FDA has not yet announced whether it intends to hold an advisory panel to review Levadex.
Chelsea Therapeutics(CHTP_)
Drug/indication: Northera for orthostatic hypotension
Approval decision date: March 28, 2012
Pfizer(PFE) and Bristol-Myers Squibb(BMY)
Drug/indication: Eliquis for prevention of stroke and blood clots in patients with atrial fibrilation.
Approval decision date: March 28, 2012
Onyx Pharmaceuticals(ONXX_)
Drug/indication: Carfilzomib for multiple myeloma
Approval decision date: March 28, 2012 (estimated, not confirmed, based on Sept. 28, 2011 filing date.
FDA accepted the carfilzomib filing on Nov. 28 but has not yet set a specific approval decision date. I'm assuming a six-month priority review because carfilzomib is a cancer drug.
Vivus(VVUS_)
Drug/indication: Qnexa for obesity
Approval decision date: April 17, 2012
FDA rejected Qnexa initially in 2010 due to safety concerns.
Vertex Pharmaceuticals(VRTX_)
Drug/indication: Kalydeco for cystic fibrosis
Approval decision date: April 19, 2012
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect.
Cell Therapeutics(CTIC_)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
Approval decision date: April 2012 (Specific date unknown.)
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval.
Amgen(AMGN_)
Drug/indication: Xgeva for prevention of bone metastases from prostate cancer.
Approval decision date: April 26, 2012
VVUS(VVUS)
Drug/indication: Avanafil for erectile dysfunction.
Approval decision date: April 29, 2012
Merck(MRK_) and Ariad Pharmaceuticals(ARIA_)
Drug/indication: ridaforolimus for sarcoma.
Approval decision date: June 5, 2012
Ironwood Pharmaceuticals(IRWD_)
Drug/indication: linaclotide for irritable bowel syndrome.
Approval decision date: June 8, 2012
Amarin(AMRN_)
Drug/indication: AMR101 for dyslipidemia.
Approval decision date: July 26, 2012
Sources: Company reports, TheStreet research, BioMedTracker.com
--Written by Adam Feuerstein in Boston

2012 FDA Expected Approvals!!

2012 FDA Approvals!!
Please help keeping this post active by clicking on some ads in this page. Thanks and good luck!

Affymax(AFFY_)
Drug/indication:peginesatide for anemia in kidney dialysis patients.
FDA advisory panel: Dec. 7, 2011
Approval decision date:March 27, 2012
Peginesatide, injected once monthly, aims to compete against Amgen's
(AMGN_) Epogen ($2.5 billion in 2010 sales) as a treatment for anemia in patients with chronic kidney disease, although peginesatide use would be limited to sicker kidney dialysis patients only. Amgen recently signed long-term Epogen supply contracts with the two largest kidney dialysis clinics in the U.S.
Pfizer(PFE_)
Drug/indication:Inlyta (axitinib) for kidney cancer
FDA advisory panel: Dec. 7, 2011
Approval decision date: Feb-April 2012
Alexza Pharmaceuticals(ALXA)
Drug/indication:Adasuve for agitation related to schizophrenia
FDA advisory panel: Dec. 12, 2011
Approval decision date: Feb. 4, 2012
Adasuve uses Alexza's proprietary Staccato inhaler system to deliver the anti-agitation medicine loxapine directly into the lungs where it gets into the bloodstream and begins to work quickly. The FDA advisory panel is expected to focus much of its attention on the potential side effects and safety issues related to delivering Adasuve into patients' lungs.
FDA initially rejected Adasuve in October 2010 due to concerns over lung safety. Alexza resubmitted the drug to FDA last August.
Vivus(VVUS), Arena Pharmaceuticals(ARNA_) and Orexigen Therapeutics(OREX_)
Drugs/indication: Qnexa, lorcaserin and Contrave for obesity.
FDA advisory panel: First quarter 2012 (exact date not yet disclosed.)
FDA held advisory panels to review all three of these controversial weight-loss drugs in 2010. FDA subsequently rejected all three drugs. In 2012, Vivus and its obesity drug competitors are back for another shot, and FDA will once again bring together a group of outside experts to weigh the pros and cons of treating obesity with a pill.
Biogen Idec(BIIB_) and Elan (ELN_)
Drug/indication:Update to the Tysabri prescribing label
Approval decision date: Jan. 20, 2012
The Tysabri label update will include information about the anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML). Doctors can use to test to determine which multiple sclerosis patients are at low or high risk for PML, a serious, potentially fatal brain infection caused by Tysabri.
Columbia Labs(CBRX_) and Watson Pharmaceuticals(WPI_)
Drug/indication:progesterone vaginal gel for risk reduction of preterm birth.
FDA advisory panel: Jan. 20, 2012
Approval decision date:Feb. 26, 2012
Amylin Pharmaceuticals(AMLN_)
Drug/indication: Bydureon for diabetes
Approval decision date: Jan. 27, 2012
This is the second shot at approval for Bydureon, a once-weekly injectable medicine for the treatment of Type 2 diabetes. Amylin recently split with its long-time marketing partner Eli Lilly
(LLY_). Alkermes(ALKS_) retains its royalty split on Bydureon sales.
Bristol-Myers Squibb(BMY_)
Drug/indication: dapagliflozin for diabetes
Approval decision date: Jan. 27, 2012
Pfizer(PFE_) and Protalix Biotherapeutics(PLX_)
Drug/indication: Uplyso for Gaucher's disease.
Approval decision date: Feb. 1, 2012
FDA has twice-rejected Uplyso due to manufacturing and quality control issues. If approved this time around, Uplyso will compete against Sanofi/Genzyme's
(SNY_) Cerezyme and Shire's Vpriv.
Teva(TEVA_) and BioSante Pharmaceuticals(BPAX_)
Drug/indication: Bio-T-Gel for hypogonadism
Approval decision date: Feb. 14, 2012
Bio-T-Gel is a once-daily gel used to treat low testosterone in men.
Corcept Pharmaceuticals(CORT_)
Drug/indication: Corlux for Cushing's Syndrome.
Approval decision date: Feb. 17, 2012
FDA will not convene an advisory panel to review Corlux.
Discovery Labs(DSCO_)
Drug/indication: Surfaxin for respiratory distress syndrome in premature infants.
Approval decision date: March 6, 2012
This is Discovery's fifth attempt at convincing FDA to approve Surfaxin.
Roche(RHHBY) and Curis(CRIS_)
Drug/indication: Vismodegib for advanced basal cell carcinoma.
Approval decision date: March 8, 2012.
MAP Pharmaceuticals(MAPP_)
Drug/indication: Levadex for migraines
Approval decision date: March 26, 2012
Levadex is an inhaled migraine drug. FDA has not yet announced whether it intends to hold an advisory panel to review Levadex.
Chelsea Therapeutics(CHTP_)
Drug/indication: Northera for orthostatic hypotension
Approval decision date: March 28, 2012
Pfizer(PFE) and Bristol-Myers Squibb(BMY)
Drug/indication: Eliquis for prevention of stroke and blood clots in patients with atrial fibrilation.
Approval decision date: March 28, 2012
Onyx Pharmaceuticals(ONXX_)
Drug/indication: Carfilzomib for multiple myeloma
Approval decision date: March 28, 2012 (estimated, not confirmed, based on Sept. 28, 2011 filing date.
FDA accepted the carfilzomib filing on Nov. 28 but has not yet set a specific approval decision date. I'm assuming a six-month priority review because carfilzomib is a cancer drug.
Vivus(VVUS_)
Drug/indication: Qnexa for obesity
Approval decision date: April 17, 2012
FDA rejected Qnexa initially in 2010 due to safety concerns.
Vertex Pharmaceuticals(VRTX_)
Drug/indication: Kalydeco for cystic fibrosis
Approval decision date: April 19, 2012
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect.
Cell Therapeutics(CTIC_)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
Approval decision date: April 2012 (Specific date unknown.)
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval.
Amgen(AMGN_)
Drug/indication: Xgeva for prevention of bone metastases from prostate cancer.
Approval decision date: April 26, 2012
VVUS(VVUS)
Drug/indication: Avanafil for erectile dysfunction.
Approval decision date: April 29, 2012
Merck(MRK_) and Ariad Pharmaceuticals(ARIA_)
Drug/indication: ridaforolimus for sarcoma.
Approval decision date: June 5, 2012
Ironwood Pharmaceuticals(IRWD_)
Drug/indication: linaclotide for irritable bowel syndrome.
Approval decision date: June 8, 2012
Amarin(AMRN_)
Drug/indication: AMR101 for dyslipidemia.
Approval decision date: July 26, 2012
Sources: Company reports, TheStreet research, BioMedTracker.com
--Written by Adam Feuerstein in Boston