Fampridine SR’s PDUFA date delayed (NASDAQ:ACOR)
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
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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
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...Silenor Approaching FDA Decision Date (SOMX)
30 November 2009
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Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), a specialty pharmaceutical company that focuses on in-licensing, developing and bringing to market treatments for psychological and neurological disorders, has announced that the US Food and Drug Administration (FDA) had given it a new Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2009 after accepting its [...]
Continue reading...Dyax approaching its PDUFA Date (DYAX)
24 November 2009
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On 8 June 2009, Dyax Corp. (NASDAQ:DYAX), a clinical stage biopharmaceutical company that discovers, develops and commercializes biotherapeutics for inflammatory and oncology diseases, announced that it had obtained from the US Food and Drug Administration a new
Continue reading...Will the $20 million payment for VIBATIV pay off? (THRX, JNJ, ALPMF)
23 November 2009
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The FDA is anticipated to decide on 11/26/09 for Vibativ (telavancin)Â as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP). This triggers a milestone payment of $10M from THRX’s partner, Astellas Pharma (ALPMF.PK).
Continue reading...CombinatoRx & Neuromed Merger at risk? (NASDAQ:CRXX)
20 November 2009
Neuromed and CombinatoRx, Incorporated (NASDAQ:CRXX)has agreedto sign a definitive merger agreementvalued $28.8 million USD on 30thJune, 2009 according to a news published by the RTT News.
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20 January 2010
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