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PDL BioPharma, Inc.

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Latest From PDL BioPharma, Inc.

FDA Accepts Kabi’s Actemra Biosimilar – Will It Be First?

Fresenius Kabi has been tipped to strike first in the race to launch a biosimilar to Actemra – a market where competition “is likely to be thin for some time.”

Biosimilars FDA

Kabi Awaits Melrose Park Fate As mAbxience Deal Closes

Fresenius Kabi is pressing on with its ‘Vision 2026’ strategic growth initiatives, with the company wrapping up its acquisition of Insud Pharma’s bio unit mAbxience. However, it remains “to some degree output constrained,” which looks set to continue to impact operations, amid staff shortages.

Biosimilars M & A

FDA’s ‘Imminent Action’ Policy Likely Not Best Path For ANDAs To Address Late Brand Label Changes

The policy allowing the FDA to work past a goal date could be used to deal with the generic delaying tactic, but an industry expert said other avenues to quickly dispatch labeling issues may be more appropriate.

Generic Drugs Drug Review

FDA’s ‘Imminent Action’ Policy Likely Not Best Path For ANDAs To Address Late Brand Label Changes

The policy allowing the FDA to work past a goal date could be used to deal with the generic delaying tactic, but an industry expert said other avenues to quickly dispatch labeling issues may be more appropriate.

Generic Drugs Drug Review
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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Eos Biotechnology, Inc.
    • LENSAR, Inc.
    • Noden Pharma DAC
    • Noden USA
    • Protein Design Labs, Inc.
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