Specialty Pharma Journal Specialty, Precision & Technology
CAMBRIDGE, Mass., Nov. 29, 2016 (GLOBE NEWSWIRE) — Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that the confirmatory Phase 3 clinical study of M923, a biosimilar HUMIRA® (adalimumab) candidate developed in collaboration with Baxalta, now part of Shire plc, in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint. The proportion …
Tag Archives: Baxalta
November, 2016
June, 2016
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6 June
Shire Completes $32 Billion Takeover of Baxalta
Dublin, Ireland – June 3, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) today completed its previously announced combination with Baxalta Incorporated (NYSE: BXLT), creating the leading global biotechnology company focused on serving patients with rare diseases and other highly specialized conditions. Through the combination, Shire expects to deliver double-digit …
March, 2016
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2 March
Baxalta Submits MAA to the EMA for its Hemophilia A Treatment
BANNOCKBURN, Ill.–(BUSINESS WIRE)– Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval of ADYNOVI, an extended circulating half-life recombinant Factor …
February, 2016
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25 February
Baxalta and Precision Biosciences Form Global Genome Editing Collaboration in Immuno-Oncology
BANNOCKBURN, Ill. & DURHAM, N.C.–(BUSINESS WIRE)–Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, and Precision BioSciences, the genome editing company, today announced a global collaboration to develop a broad series of allogeneic chimeric antigen receptor (CAR) T …
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10 February
CTI Biopharma’s Myelofibrosis Study Placed on Full Clinical Hold, Following Patient Deaths
SEATTLE, Feb. 9, 2016 /PRNewswire/ — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today provided an update regarding the clinical studies being conducted under the Company’s Investigational New Drug (“IND”) application for pacritinib. Following the issuance of the Company’s February 8, 2016, press release describing the partial clinical …
January, 2016
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11 January
Baxalta and Coherus’ Enbrel Biosimilar Meets Primary Endpoint in Late-Stage Study
REDWOOD CITY, Calif., and BANNOCKBURN, Ill., Jan. 11, 2016 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ:CHRS) and Baxalta Incorporated (NYSE:BXLT) today announced that CHS-0214, a proposed biosimilar of Enbrel® (etanercept), met its primary endpoint in a confirmatory, double-blind, randomized, controlled, two-part clinical study. This ongoing study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel in patients …
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11 January
Shire to Acquire Baxalta for $32 Billion
Shire plc (LSE: SHP, NASDAQ: SHPG) and Baxalta Incorporated (NYSE: BXLT) today announced that the boards of directors of both companies have reached an agreement under which Shire will combine with Baxalta . Under the agreement, Baxalta shareholders will receive $18.00 in cash and 0.1482 Shire ADS per Baxalta share. …
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4 January
Baxalta Enters $1.6 Billion Immuno-Oncology Deal with Symphogen
BANNOCKBURN, Ill. & COPENHAGEN, Denmark–(BUSINESS WIRE)–Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, and Symphogen, a private biopharmaceutical company developing recombinant antibodies and antibody mixtures, today announced a broad strategic immuno-oncology collaboration. Under the terms of the …
December, 2015
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28 December
Baxalta and Momenta’s Humira Biosimilar Candidate Meets Primary Endpoint in PK Study
BANNOCKBURN, Ill. and CAMBRIDGE, Mass., Dec. 21, 2015 (GLOBE NEWSWIRE) — Baxalta Incorporated (NYSE:BXLT) and Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced that M923 met the primary endpoint in a randomized, double-blind, three-arm, parallel group, single-dose study. The primary objective of the study was to evaluate the pharmacokinetics of M923 compared …
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8 December
Baxalta Wins FDA Approval for Vonvendi for Treatment of Patients with Von Willebrand Disease
BANNOCKBURN, Ill.–(BUSINESS WIRE)– Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (Recombinant)]. VONVENDI is the first and only recombinant treatment for …