Archive | January, 2010
Zactima’s FDA Application withdrawn (NASDAQ:AZN)
In June 2009, AstraZeneca (NASDAQ:AZN) submitted applications to both the United States of America’s regulator the Food & Drug Administration (FDA) and the European Medicines Agency (EMEA), which is the European equivalent of the FDA. The applications were submitted for the drug that the company has recently discovered and developed – called ZACTIMA (the proposed [...]
Continue reading...Results from Phase 2 trial of Sapacitabine expected on January 31 (Nasdaq:CYCC)
29 January 2010 – 7:22 pm PST
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Sapacitabine is a drug that is being developed by Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC or Nasdaq: CYCCP), a biopharmaceutical company that discovers, develops and then commercialized drugs for cancers and other life-threatening diseases.
Continue reading...AIMM Trial Expected to End on January 31 (NASDAQ:VICL)
29 January 2010 – 6:45 pm PST
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On December 28, 2009, Vical Incorporated (NASDAQ: VICL) disclosed that an independent organization – called the Safety Monitoring Board (SMB) – had been analyzing the safety issues of the company’s Phase 3 AIMM (Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma) trial.
Continue reading...Phase 2 trial of ADXS11 likely to begin on January 31 (OTC:ADXS)
29 January 2010 – 6:29 pm PST
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ADXS11-001 is a “live, attenuated Listeria monocytogenes (Lm)†vaccine that is being developed by Advaxis Inc, (OTC:ADXS). The company had recently completed the Phase 1 trial of the novel vaccine. On October 1, 2009, the company announced that the results received from the Phase 1 trial had been favorable. Now the company plans to begin the [...]
Continue reading...FDA decision on WC 3016 anticipated tomorrow (NASDAQ:WCRX)
25 January 2010 – 11:56 am PST
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WC 3016 is a type of oral contraceptive (of low dose) that is being developed by Warner Chilcott Ltd. (NASDAQ: WCRX). This drug is used by women for birth control. Since it is still in its development phase, it is not sold in the market yet.
Continue reading...Stedesa’s FDA Decision Anticipated Soon (NASDAQ:SEPR)
20 January 2010 – 10:58 am PST
Stedesa is a drug that has been developed by Sepracor Inc. (NASDAQ:SEPR). The company has already submitted the application – known as the New Drug Application (NDA) – for the approval of the United States of America’s Food & Drug Administration to market Stedesa.
Continue reading...Fampridine SR’s PDUFA date delayed (NASDAQ:ACOR)
20 January 2010 – 10:51 am PST
Fampridine SR is a drug that has been developed by Acorda Therapeutics, Inc. (NASDAQ:ACOR). The company has already submitted the application – known as the New Drug Application (NDA) –
Continue reading...Tarceva’s PDUFA date extended (NASDAQ:OSIP)
20 January 2010 – 10:48 am PST
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Tarceva – which is the brand name for the generic drug erlotinib – is co-marketed by OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) and Roche Holding AG (NASDAQ:RHHBY). Both companies have already submitted a special type of application – known as the Supplemental new drug application (sNDA) – regarding Tarceva to the United States of America’s Food & [...]
Continue reading...No Partner for Afresa; the PDUFA date may get delayed (NASDAQ:MNKD)
20 January 2010 – 9:00 am PST
Afresa (also known as Afrezza) is a type of insulin developed by Mannkind Corporation (NASDAQ: MNKD). The company has already submitted the application for the approval of Food & Drug Administration to market Afresa.
Continue reading...World Infertility Device Leader (OTC:IVOB)
19 January 2010 – 2:33 pm PST
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World Health Organization statistics imply that infertility and sterility will be the third most serious diseases in the 21st century after cancer and cardiovascular diseases, according to a Life Times report.
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30 January 2010 – 10:42 am PST
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