Specialty Pharma Journal Specialty, Precision & Technology
BRIDGEWATER, N.J., and SECAUCUS, N.J., Nov. 01, 2018 (GLOBE NEWSWIRE) — Clinical Genomics, a leading innovator of tests for colorectal cancer, and Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced a 5-year extension to their U.S. supply agreement for the InSure® ONE™ fecal immunochemical test …
Tag Archives: colorectal cancer
November, 2018
October, 2018
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24 October
FDA Approves Spectrum Pharmaceuticals’ Khapzory for Injection for Three Indications
HENDERSON, Nev.–(BUSINESS WIRE)–Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved KHAPZORY (levoleucovorin) for injection, a folate analog for three indications: • Rescue …
August, 2018
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22 August
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 …
July, 2018
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11 July
Bristol-Myers Squibb’s Opdivo-Yervoy Combo Receives FDA Approval for Certain Patients with Metastatic Colorectal Cancer
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) …
May, 2018
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10 May
Genentech’s Tecentriq Fails to Meet its Primary Endpoint in Late-Stage Colorectal Cancer Trial
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMblaze370 study evaluating the combination of TECENTRIQ® (atezolizumab) and COTELLIC®(cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. The study evaluated the combination in …
January, 2018
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22 January
Opdivo in Combination with Yervoy Demonstrates Clinical Activity in Previously Treated Patients with dMMR or MSI-H Metastatic Colorectal Cancer
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced new data from a cohort of the phase 2 CheckMate -142 trial evaluating Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of patients with DNA mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC). With a median of 13.4 months of follow-up, the primary …
November, 2017
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15 November
Roche’s VENTANA MMR IHC Panel Receives FDA Clearance for Patients Diagnosed with Colorectal Cancer
TUCSON, Ariz., Nov. 14, 2017 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food & Drug Administration (FDA) clearance of the VENTANA MMR IHC Panel, which provides clinicians with a comprehensive group of immunohistochemistry (IHC) tests for patients diagnosed with colorectal cancer. The tests detect certain proteins …
August, 2017
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1 August
Bristol-Myers Squibb’s Opdivo Receives FDA Approval for Opdivo in Certain Patients with Advanced Colorectal Cancer
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment …
June, 2017
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30 June
Illumina Granted FDA Approval for Next-Generation Sequencing Cancer Companion Diagnostic Test Kit
SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ:ILMN) today announced its Extended RAS Panel, an FDA-approved next-generation sequencing (NGS) kit that meets the newly published guidelines for evaluation of colorectal cancer from the American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the …
May, 2017
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22 May
Nektar and Takeda Enter Research Deal Exploring Combination Cancer Therapy Approaches
SAN FRANCISCO, May 22, 2017 /PRNewswire/ — Nektar Therapeutics (NASDAQ: NKTR) announced today that Takeda Pharmaceutical Company Limited (TSE: 4502) and Nektar have entered into a research collaboration to explore the combination of Nektar’s lead immuno-oncology candidate, the CD122-biased agonist NKTR-214, with five oncology compounds from Takeda’s cancer portfolio. The …