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Oncology

FDA Approves Roche’s Cobas EGFR Mutation Test v2 as a Companion Diagnostic with Iressa

PLEASANTON, Calif., Aug. 23, 2018 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval from the U.S. Food and Drug Administration (FDA) for the cobas® EGFR Mutation Test v2 as a companion diagnostic test (CDx) with IRESSA®. A CDx test provides information that is essential for the safe …

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Pfizer and Astellas Amend Clinical Research Protocols to Accelerate Completion Dates for Phase 3 Trials of Enzalutamide in Prostate Cancer

NEW YORK & TOKYO–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI® (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC). …

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Pfizer and Exact Sciences Enter Agreement to Co-Promote Colorectal Cancer Screening Test Cologuard

MADISON, Wis. and NEW YORK, Aug. 22, 2018 /PRNewswire/ — Exact Sciences Corp. (Nasdaq : EXAS ) and Pfizer Inc. (NYSE : PFE ) today announced an agreement through 2021 to co-promote Cologuard, the first and only FDA-approved non-invasive stool DNA screening test for colorectal cancer. Pfizer will join Exact …

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FDA Expands Approval of Agilent’s Companion Diagnostic in Urothelial Carcinoma

SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma. The assay is now approved to identify patients with urothelial carcinoma who may benefit from KEYTRUDA, an anti-PD-1 …

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AbbVie Exercises Option to License Argenx’s GARP Checkpoint Inhibitor

Breda, the Netherlands/Ghent, Belgium – argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced the exercise by AbbVie of its exclusive license option to develop and commercialize ARGX-115, an antibody targeting the …

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Lixte Biotechnology and Moffitt Cancer Center to Initiate Trial Evaluating LB-100 in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndrome

EAST SETAUKET, NY, Aug. 21, 2018 (GLOBE NEWSWIRE) — Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT) announced that it has entered into a Clinical Trial Agreement and Exclusive License Agreement with Moffitt Cancer Center to conduct a Phase 1b/2 study of the safety and therapeutic benefit of Lixte’s lead clinical compound, LB-100, in patients with …

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Rexahn Pharmaceuticals Partners with Merck to Evaluate RX-5902 in Combination with Keytruda in Triple Negative Breast Cancer

ROCKVILLE, Md. , Aug. 21, 2018 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NYSE American:RNN), a clinical stage biopharmaceutical company developing innovative, targeted therapeutics for the treatment of cancer, today announced that it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and …

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Agena Bioscience Collaborates with PerkinElmer to Optimize Liquid Biopsy Workflow

SAN DIEGO, Aug. 21, 2018 /PRNewswire/ — Agena Bioscience (Agena) announced today that they have entered into a collaboration with PerkinElmer, incorporating the LabChip® GX Touch™ nucleic acid analyzer for quality assessment and quantitation of DNA in the upfront workflow of Agena’s MassARRAY® system. The companies have focused on targeting …

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Large Study Finds HPV Vaccination Does Not Negatively Impact Fertility in Adolescents

PORTLAND, Ore., Aug. 21, 2018 /PRNewswire/ — Adolescents who receive recommended vaccinations, including for human papillomavirus (or HPV), have no increased risk of primary ovarian insufficiency, also known as premature menopause, according to a Kaiser Permanente study published today in Pediatrics. Rates of HPV vaccination have lagged behind coverage rates …

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FDA Approves Expanded Label for Merck’s Keytruda in Patients with Metastatic Nonsquamous NSCLC

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 approved an expanded label for KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous …

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