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Dynavax Technologies Corporation

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Latest From Dynavax Technologies Corporation

Orphan Drug Exclusivity: In Narrow Application Of Catalyst Ruling, FDA Retains Its Existing Regs

US FDA will continue to tie orphan exclusivity to uses or indications for which the drug was approved. Attorneys say this buys agency time to sort out complex policy and legal questions and continue to seek legislative fix. Additional litigation is also possible, as happened in Depomed case.

FDA Rare Diseases

New Drug Exclusivity Not Impacted By Impurities In Compound, Court Finds In Loss For Sandoz

DC Circuit Court upholds FDA’s grant of new chemical entity exclusivity to Sanofi’s multiple sclerosis drug Aubagio (teriflunomide) even though the agency had previously approved teriflunomide as an impurity in Sanofi’s Arava (leflunomide). FDA reviews known impurities in drugs only to assess their impact on safety and efficacy, not to approve them, court says.

FDA Legal Issues

Deal Watch: AbbVie Leads J.P. Morgan Deal Rush, But BI, Genentech And Lilly Also Big Players

As the usual flurry of deals coincides with the J.P. Morgan Healthcare Conference, AbbVie signed an mRNA pact with Anima and a cancer research tie-up with Immunome.

Deal Watch Business Strategies

Orphan Exclusivity Dilemma: Without Legislative Fix, US FDA May Seek New Regulation

FDA didn’t get policy rider it wanted which would have reversed the Catalyst court ruling that the agency cannot limit a drug’s orphan exclusivity to its approved indication. One attorney says the clearest path forward is for FDA to issue new rulemaking and face additional litigation.

Rare Diseases Legislation
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
    • Vaccines
  • Biotechnology
    • Antisense, Oligonucleotides
    • Drug Discovery Tools
    • Large Molecule
  • Other Names / Subsidiaries
    • Symphony Dynamo, Inc. (SDI)
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