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Latest From Nektar Therapeutics
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.
The Swiss pharma company has followed Merck & Co. and Sanofi by buying into the TL1A-inhibitor class, with pharma chief Teresa Graham confident RVT-3101 could be its next best-in-class blockbuster
But the partners will have to avoid the pitfalls that have bedevilled several other expensive licensing deals.
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.
- Drug Delivery
- Drug Discovery Tools
- Large Molecule
- Other Names / Subsidiaries
- Aerogen, Inc.
- Inhale Therapeutic Systems, Inc.
- Inheris Biopharma, Inc.
- Nektar Therapeutics (India) Private Limited
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