Eagle Pharmaceuticals, Inc.
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Latest From Eagle Pharmaceuticals, Inc.
Cool Down: US FDA’s July User Fee Calendar Suggests Slower Pace After Torrid June
FDA action is expected on a handful of novel agents, including Daiichi Sankyo’s quizartinib, and conversion to full approval for Eisai/Biogen’s Leqembi.
Eagle: ‘No Room, No Reason’ For A Generics Business, As Vasopressin Pulled
In something of a surprise, Eagle Pharmaceuticals has announced its exit from the generic vasopressin market – one year after a hard-fought and hard-won launch.
Industry Polarized In Best Manufacturing Approach For Cell And Gene Therapy
Ongoing debate emanates from industry players around the most efficient design of the manufacturing process for cell and gene therapies. The arguments surrounding outsourcing, centralizing, and standardizing processes will no doubt continue through into the near future.
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.
Company Information
- Industry
- Pharmaceuticals
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Pharmaceuticals
- Generic Drugs
- Specialty Pharmaceuticals
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Drug Delivery
- Transdermal
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Biotechnology
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Large Molecule
- Antibodies
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Large Molecule
- Other Names / Subsidiaries
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- Arsia Therapeutics
- Eagle Biologics
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