Jazz Pharmaceuticals to Showcase Rapidly Expanding Oncology Pipeline and Advances in Current Product Portfolio at ASCO 2023
TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.
MISSISSAUGA, ON, March 8, 2023 /CNW/ - Jazz Pharmaceuticals plc (NASDAQ: JAZZ) announced today that Vyxeos® (daunorubicin and cytarabine liposome for injection) is now included on eight additional provincial drug formularies, including British Columbia, Ontario, Saskatchewan, Manitoba, New Brunswick, Nova Scotia, Alberta, and Newfoundland and Labrador. Vyxeos is indicated for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or acute myeloid leukemia (AML) with myelodysplasia-related changes (AML-MRC).1
The shuttering of Teva’s long troubled manufacturing facility in Irvine, California, may create shortages of up to 24 generic sterile injectable drugs, including five essential medications of which the company supplied more than 15% of the market last year, according to an industry group.
BDR Pharma has launched India’s first Generic- Midostaurin under the nbrand name MSTARIN, which is indicated in rare, hard-to-treat cancers, nthe company notified via a statement.
DUBLIN, March 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. The approval of Vyxeos for this indication is supported by safety data from two single-arm trials: AAML1421, conducted by the Children's Oncology Group (COG) and CPX-MA-1201, conducted by Cincinnati Children's Hospital (CCH) and evidence of effectiveness from an adequate and well-controlled study in adults.
Cost regulators for the NHS in England and Wales have now published final guidelines recommending Mylotarg, alongside daunorubicin and cytarabine, as an option for untreated de novo CD33-positive acute myeloid leukaemia (AML).
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Jazz Pharmaceuticals’ Vyxeos formulation to treat adults with two types of secondary Acute Myeloid Leukaemia (AML).
Jazz Pharmaceuticals plc announced that the National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion for routine use on the National Health Service (NHS) in England and Wales for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) two types of secondary AML.
DUBLIN, Aug. 27, 2018 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission approved Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine.