BC Week In Review | Nov 9, 2018
Company News

NICE recommends Jazz's Vyxeos for AML

The U.K.'s NICE issued a final appraisal determination (FAD) recommending Vyxeos daunorubicin/cytarabine to treat adults with newly diagnosed therapy-related acute myelogenous leukemia (AML) or AML with myelodysplasia-related changes. Vyxeos is a liposomal formulation of daunorubicin...
BC Week In Review | Nov 9, 2018
Company News

Earnings roundup: Alnylam off after first peek at Onpattro sales

Shares of at least three companies moved double digits on Nov. 7 after the companies provided 3Q18 financial results, with Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) sliding after reporting sales for newly launched amyloidosis drug Onpattro patisiran...
BC Extra | Nov 7, 2018
Company News

Earnings roundup: Alnylam off after first peek at Onpattro sales

Shares of at least three companies moved double digits on Wednesday after the companies provided 3Q18 financial results, with Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) sliding after reporting sales for newly launched amyloidosis drug Onpattro patisiran and...
BC Week In Review | Aug 10, 2018
Company News

Jazz, MD Anderson partner to evaluate hematologic cancer therapies

University of Texas MD Anderson Cancer Center (Houston, Texas) and Jazz Pharmaceuticals plc (NASDAQ:JAZZ) partnered to evaluate treatment options for hematologic malignancies, with an initial focus on evaluating and generating additional data for Vyxeos daunorubicin/cytarabine....
BC Week In Review | Jul 13, 2018
Clinical News

EMA's CHMP recommends CAR Ts, rare disease therapies

EMA's CHMP recommended for approval Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel, the first two CAR T therapies backed by the committee. CHMP also recommended a handful of other Orphan drug candidates, including Cablivi caplicizumab, a...
BC Extra | Jun 29, 2018
Company News

CHMP backs CAR Ts, Orphan candidates

EMA's CHMP recommended for approval Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel, the first two CAR T therapies backed by the committee. CHMP also recommended a handful of other Orphan drug candidates, including Cablivi caplicizumab, a...
BC Week In Review | Mar 2, 2018
Clinical News

CHMP backs approval for Pfizer's AML triple combo

EMA's CHMP recommended approval of Mylotarg gemtuzumab ozogamicin from Pfizer Inc. (NYSE:PFE) in combination with daunorubicin and cytarabine to treat previously untreated, CD33-positive acute myelogenous leukemia (AML), except acute promyelocytic leukemia (APL), in patients ages...
BC Extra | Feb 24, 2018
Company News

CHMP backs approval of Mylotarg, Alpivab, Kineret

EMA's CHMP announced a spate of opinions Friday, including positive recommendations for Mylotarg gemtuzumab ozogamicin, Alpivab peramivir and Kineret anakinra, as well as the expected negative opinion for Nerlynx neratinib. The committee recommended approval of...
BC Week In Review | Dec 8, 2017
Company News

NICE does not recommend Novartis' Rydapt for AML

The U.K.'s NICE issued draft guidance recommending against the use of Rydapt midostaurin (CGP 41251, PKC412) from Novartis AG (NYSE:NVS; SIX:NOVN) to treat newly diagnosed, FMS-like tyrosine kinase 3 (FLT3; CD135)-mutant acute myelogenous leukemia (AML)...
BC Week In Review | Nov 9, 2017
Clinical News

Novartis's Rydapt approved for AML, systemic mastocytosis in EU

In September, the European Commission approved Rydapt midostaurin (CGP 41251, PKC412) from Novartis AG (NYSE:NVS; SIX:NOVN) to treat acute myelogenous leukemia (AML), advanced systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm and mast cell leukemia....
Items per page:
1 - 10 of 191