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Impax Laboratories, Inc.

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Latest From Impax Laboratories, Inc.

US Draft Bill Highlights Perceived China Biotech Threat

A draft bill from the US House related to national security issues sent WuXi Biologics' shares tumbling over concerns around increased US scrutiny of Chinese firms, which a company clarification did little to dispel.  

China United States

In Swift Challenge To Orange Book Patent Listings, Federal Trade Commission Fills FDA Ministerial Gap

Agency sends letters to 10 companies saying they improperly listed patents in US FDA’s Orange Book covering drug-device combination products. FTC does not specify why it believes the patents were improperly listed.

Intellectual Property Legal Issues

FDA Change In Bioequivalence Requirements Leads To Downgrade Of Accord’s Generic Tacrolimus

After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

Generic Drugs Post Market Regulation & Studies

Gilead, Teva Document Disclosures Helped Sway Jury In Rare Pay-For-Delay Trial

Teva’s counsel notes a key factor in the jury's finding that Gilead’s patent settlement with Teva did not include a reverse payment to delay entry of Truvada and Atripla generics. A second trial will proceed on claims a collaboration agreement between Gilead and Janssen was anticompetitive.

Legal Issues Generic Drugs
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Company Information

  • Industry
  • Pharmaceuticals
    • Generic Drugs
    • Specialty Pharmaceuticals
    • Drug Delivery
      • Controlled Release
  • Other Names / Subsidiaries
    • Amedra Pharmaceuticals LLC
    • CorePharma LLC
    • Impax Generics
    • Impax Specialty Pharma
    • Lineage Therapeutics Inc.
    • Tower Holdings, Inc.
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