Mallinckrodt plc
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Latest From Mallinckrodt plc
Keeping Track: Parsaclisib, Kymriah Applications Target Non-Hodgkin Lymphomas; AbbVie Gets New Use For Old Ophthalmic
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Deal Watch: J&J Partners On Bispecific Antibody R&D With F-Star, Xencor
Janssen Biotech adds to its bispecific antibody pipeline for cancer via pair of collaborations. Ipsen and Accent pair up to investigate new target for acute myeloid leukemia.
US FDA Loses Orphan Exclusivity Case While HHS Wins Dismissal Of Pfizer Kickback Complaint
In rare loss for FDA, appeals court reverses district court decision tossing Catalyst’s suit over Orphan Drug Act, saying deference should not have been granted to agency’s interpretation. District court finds it is too early to rule on one Pfizer charity co-pay program but backs broad reading of Anti-Kickback Statute.
Premature PRV: US FDA Mistakenly Announces Voucher Award For Enzyvant Ahead Of Approval
Congenital athymia treatment Rethymic (RVT-802) is still under FDA review, with an 8 October user fee goal date, but FDA announced the regenerative medicine product had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.
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