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    FDA to Rule on Alexza’s Resubmitted Adasuve Application

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    Healthcare Finance: Celgene, AMAG, Takeda Present Hematology Data

    Several key presentations will be made at the American Society of Hematology (ASH) annual meeting in Atlanta, Georgia on Dec. 8-11. On Dec. 11, Celgene will present progression free survival (PFS) and overall survival (OS) data from the MM-003 study, a pivotal Phase III trial that tested pomalidomide in refractory resistant multiple myeloma. The drug [...]

    FDA Panel Examines Zogenix’s Zohydro ER

    The new drug application (NDA) for Zogenix/Alkermes/Paladin Labs’ Zohydro ER (hydrocodone bitartrate extended-release capsules) will be reviewed by a panel advising the FDA this week. To continue reading click here: To subscribe to the full newsletter please contact us at: Annie Gustavson Bloomberg Briefs 212-617-0544

    Healthcare Q&A: Chris Garabedian on Sarepta’s Plans for Eteplirsen

    Chris Garabedian, President and Chief Executive Officer of Sarepta, told Bloomberg Brief: Healthcare Finance’s Elizabeth Krutoholow that the results seen with lead drug eteplirsen for Duchenne Muscular Dystrophy (DMD) have provided proof-of-concept to support the company’s phosphorodiamidate morpholino oligomer technology. He said the company will focus on DMD and eventually other rare genetic diseases. Sarepta [...]

    Theravance’s Vibativ Faces FDA Panel Review

    An FDA Anti-Infective Drugs Advisory Committee will examine Theravance’s Vibativ (telavancin) for nosocomial pneumonia on Nov. 29. This event will be webcast on the Bloomberg terminal. Briefing documents for the panel will be released by the FDA by Nov. 27. To continue reading click here.

    Dynavax’s Hepatitis B Vaccine Up For FDA Review

    Dynavax’s lead compound Heplisav, a vaccine for hepatitis B, will be reviewed by the FDA Vaccines and Related Biological Products Advisory Committee on Nov. 15. Briefing documents for the panel will be released by the FDA by Nov. 13. Read more>> 

    FDA Panel Examines Novo’s Tresiba and Ryzodeg

    The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to review Novo Nordisk’s insulin Degludec (Tresiba) and DegludecPlus (Ryzodeg, insulin Degludec/insulin aspart) for type I and type II diabetes on Nov. 8. Read more>>

    Meningitis Outbreak May Affect Rights of Drug Compounders

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    Aegerion, Sanofi/Isis Face FDA Committee Review

    Aegerion’s lead drug candidate lomitapide and Sanofi and partner Isis Pharmaceutical’s mipomersen will be discussed by a panel advising the FDA this week. Both drugs were developed to treat homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder. Read more>>

    EMA May Approve Most Orphan Products in 2012

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