Eagle Pharmaceuticals, Inc.
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Latest From Eagle 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.
Teva Lowers Forecast As Q3 Revenues Decline Amid Growing Generic Competition
The Israeli firm’s third-quarter revenues and profits decreased as its product sales dipped due to alternative options and generic competition leading it to lower its full-year guidance, but its opioid crisis financial settlement remains on track.
Gamida Set For Breakthrough Transplant Therapy Approval – But Cash Problems Could Hit Launch
With a new CEO at the helm, Gamida is closing in on an FDA approval, but a lack of cash could hobble its US launch efforts for allogeneic cell therapy product omidubicel.
Arcutis Eyes Atopic Dermatitis Opportunity With Ducentis Buy
Arcutis's CEO believes that with "a modest investment," the company can generate proof-of-concept data "against a de-risked target in a high-value indication,” Ducentis's preclinical atopic dermatits drug DS-234.
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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