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FDA Issues Draft Guidance on Nanotechnology
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Amy Ritter
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An FDA guidance has provided information for products that involve the application of nanotechnology, and rationales for those points.
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Merck to Develop Biosimilar with Korean Chemical Manufacturer
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Patricia Van Arnum
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Merck and Hanwha Chemical have formed an exclusive global agreement to develop and a commercialize a biosimilar of Enbrel, a drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.
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FDA Reviews First Year of Bad Ad Program
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Erik Greb
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After looking back at the first year of its Bad Ad outreach program, FDA judged that the initiative has successfully raised awareness about misleading promotion, according to an FDA press release.
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GSK Expands its Vaccine Presence in China
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Stephanie Sutton
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GlaxoSmithKline has entered into an agreement to purchase Shenzhen Neptunus? stake in a previously formed joint venture between the companies involved in the development and manufacture of influenza vaccines in China, Hong Kong, and Macau.
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Week of June 13, 2011: Company and People Notes: Biogen Idec Receives Approval for the Avonex Pen; Xceleron Makes Several Senior Appointments; and More.
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Biogen Idec Receives Approval for the Avonex Pen; Xceleron Makes Several Senior Appointments; and More.
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Regulatory Roundup: FDA Takes Action Against Drug Manufacturer and Distributor
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FDA Issues Consent Decree of Condemnation, Forfeiture, and Permanent injunction Against H&P Industries, the Triad Group, and Three Individuals.
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