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    NEWS

    DRUGS & DEVELOPMENTS

    MARKET INTEL by PharmaCompass

    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.
    All News #Library
    Quality

    AbbVie, Amgen, Lilly Urge FDA to Update Post-Approval Rules

    BIOSPACE

    FDA declines to grant Amgen’s Lumakras full approval in lung cancer

    ENDPTS

    Prolia (denosumab) by Amgen: Drug Safety Communication - FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis

    FDA

    Compliance officer profited off Horizon-Viela and Jazz-GW deals

    FIERCEPHARMA

    FDA shoots down Spectrum`s neutropenia drug, citing manufacturing issues

    ENDPTS

    Go or no go? Esperion`s double whammy and a look to priority reviews

    EVALUATE

    Pfizer Calls for FDA Guidance to Address False and Misleading Biosimilar Ads

    RAPS

    EMA’s CHMP Rejects Two Drugs Approved by US FDA in 2017

    RAPS

    Business as usual at Amgen following voluntary evacuation at Cali site

    BIOPHARMA

    Coherus slashes staff by a third after biosimilar knockback

    FIERCE BIOTECH

    After FDA Rejection, Bay Area`s Coherus Axes 30% of Employees

    BIOSPACE

    EMA raises manufacturing questions over Novartis biosimilar production

    FIERCE PHARMA

    Amgen Migraine Drug Winning the Race to Market

    PHARMAMANUFACTURING

    Eleven medicines leap towards EU approval

    PHARMATIMES

    Amgen Asks SC to Reject Challenge to Ruling that Notice of Commercial Marketing

    FDA LAW BLOG

    Amgen files Declaratory Judgment Action against Sandoz over NEULASTA® Biosimilar

    PATENT DOCS

    The FDA offers a controversial solution to the biosimilars name game

    FIERCE BIOTECH

    FDA proposes adding suffixes to distinguish biosimilar drug names

    REUTERS

    Amgen v. Sandoz (Fed. Cir. 2015)

    PATENT DOCS

    FDA panel also backs Amgen`s PCSK9 inhibitor

    PHARMATIMES

    Amgen v. Sandoz -- Federal Circuit Oral Argument

    PATENT DOCS

    Awesome Baby; We Love This Game! An Update on Pending Hatch-Waxman and BPCIA Litigation

    FDA LAW BLOG

    Denied Again! Another Obstacle to Biosimilar First Launch Falls with FDA Rejection of Amgen’s Certification Petition; Meanwhile, an Appeal is Filed in the Patent Dance Litigation

    FDA LAW BLOG

    Amgen Doubles Down On Bid To Block Novartis` Biosimilar Neupogen

    FIERCE PHARMA

    Denied! District Court Rules in NEUPOGEN Biosimilar Litigation; Says that the BPCIA’s “Patent Dance” Procedures are Optional, and...

    FDA LAW BLOG

    Amgen Loses Bid to Block a Biosimilar Version of its Best-Selling Drug

    PHARMALOT

    State Gives $19M in Tax Breaks to Life Science Firms Who Will Add 1,075 New Jobs

    BOSTON BUSINESS JOURNAL

    FDA Proposal Spurs Fight Over Free Speech and Patient Safety

    PHARMALOT

    FDA Proposal to Allow Drug Reps to Circulate Data Draws Protests

    REUTERS

    Biosimilars bill Approved by Colorado Legislature

    DENVER BUSINESS JOURNAL

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