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...
BioCentury | Oct 6, 2017
Finance

Bargain shopping

With all companies valued over $1 billion increasing a median of at least 16.8% in 1H17, investors went bargain shopping in the $500-$999 million tier in 3Q17. The group outperformed all other market cap bands,...
BioCentury | Oct 6, 2017
Finance

Coasting on catalysts

While buysiders do not expect any sector-moving milestones in the wake of a catalyst-heavy third quarter, they will have at least 21 Phase III milestones and 23 PDUFA dates on their radar. But the biggest...
BC Extra | Sep 2, 2017
Company News

FDA approves Pfizer's Mylotarg for AML

On Friday, FDA approved a BLA from Pfizer Inc. (NYSE:PFE) for Mylotarg gemtuzumab ozogamicin to treat adults with newly diagnosed, CD33-positive acute myelogenous leukemia and for relapsed or refractory CD33-positive AML in adults and in...
BC Week In Review | Aug 4, 2017
Clinical News

FDA approves Jazz's Vyxeos for AML

FDA approved Vyxeos (CPX-351) from Jazz Pharmaceuticals plc (NASDAQ:JAZZ) to treat adults with 2 types of acute myelogenous leukemia (AML) -- newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC). On Aug. 3,...
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