Oncology

Seismic Bio Partners With Twist Bioscience for Discovery and Optimization of Antibodies

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Seismic Bio, Inc., an immuno-oncology company focused on bispecific antibody development, today announced a partnership for the discovery and optimization of antibodies to …

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Novartis Announces Kymriah Meets Primary Endpoint at Interim Analysis of Pivotal Study in Follicular Lymphoma

Basel, August 4, 2020 — Novartis today announced positive results from the Phase II ELARA trial of Kymriah® (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL). At the interim analysis, the global study met its primary endpoint of complete response rate (CRR), as assessed by independent review committee. CRR …

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FDA Approves Monjuvi in Combination with Lenalidomide for Treatment of Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

PLANEGG, Germany & MUNICH & WILMINGTON, Del.–(BUSINESS WIRE)–MorphoSys AG (FSE:MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell …

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Siemens Healthineers to Acquire Varian Medical for $16.4 Billion

/PRNewswire/ — Varian (NYSE: VAR) today announced that it has entered into a definitive agreement to combine with Siemens Healthineers AG (Frankfurt: SHL) in an all-cash transaction valued at $16.4 billion on a fully diluted basis. Under the terms of the agreement, which has been unanimously approved by Varian’s Board …

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FDA Approves Genentech’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq ® (atezolizumab) plus Cotellic ® (cobimetinib) and Zelboraf ® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination …

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Guardant Health and Radius Health Partner to Develop Liquid Biopsy Companion Diagnostic for Elacestrant

REDWOOD CITY, Calif., July 30, 2020 (GLOBE NEWSWIRE) — Guardant Health, Inc. (Nasdaq: GH) today announced a strategic collaboration with Radius Health, Inc. (Radius, Nasdaq: RDUS) to pursue regulatory approval of the Guardant360® CDx as a companion diagnostic for elacestrant (RAD1901), an investigational selective estrogen receptor degrader (SERD) being studied in the treatment …

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AstraZeneca’s Tagrisso Granted Breakthrough Therapy Designation by the FDA for Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s TAGRISSO® (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent. The Food and Drug Administration’s (FDA) BTD is …

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FDA Grants Breakthrough Therapy Designation to Takeda’s Pevonedistat for Treatment of Higher-Risk Myelodysplastic Syndromes

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS). Pevonedistat, a first in class NEDD8-activating enzyme (NAE) inhibitor, could be …

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Merck Announces Two FDA Regulatory Milestones for Keytruda in Triple-Negative Breast Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted two new supplemental Biologics License Applications (sBLAs) for KEYTRUDA, Merck’s anti-PD-1 therapy. The FDA has accepted and granted priority review for a new sBLA …

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Bristol Myers and bluebird bio Announce Submission of BLA to the FDA for Idecabtagene Vicleucel for Relapsed and Refractory Multiple Myeloma

PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell …

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