Catalyst Pharmaceuticals, Inc.
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Latest From Catalyst Pharmaceuticals, Inc.
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.
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.
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.
Asia Deal Watch: Kelun Partners With Merck A Third Time, Optioning Rights To Seven ADCs
Already partnered on antibody-drug conjugates and a Phase III breast cancer candidate, Merck could pay up to $9.3bn under its third pact in 2022 with Kelun. Eisai divests Fycompa to Catalyst.
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