Jazz Pharmaceuticals plc
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Latest From Jazz Pharmaceuticals plc
Jazz Hits High Note With Updated Zanidatamab Data In Biliary Tract Cancer At ASCO
The company said it is in talks with the US FDA for an accelerated approval filing of the HER2-directed bispecific antibody, which showed better ORR and PFS than the standard of care.
FTC Rebukes Supernus Efforts To Block Sales Of Injector Pen For Use With Generic Apokyn
Agency refutes Supernus’ defense that Sage’s generic drug cartridges are ‘free-riding’ on the supply of the injector pen for its branded product. Company’s alleged exclusionary contract with pen distributor and pressure on specialty pharmacies not to provide the generic involve important antitrust issues, FTC tells court.
iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data
Panel favors elimination of 19-day lockout after patients who can become pregnant miss the first prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.
Krka Talks Russia, Ukraine, One Year After Conflict Began
Slovenia’s Krka enjoyed a solid year for its dominant Prescription Pharmaceuticals business, with sales climbing by 7% on the back of growth for all six of its geographic business units.
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