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Author Archives: Kristen

Opdivo OK’d for adjuvant treatment of melanoma

Jan. 4, 2018—Bristol-Myers Squibb announced the FDA has approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. The purpose of adjuvant therapy is to reduce the risk of recurrence following surgical removal of the tumor and lymph nodes that contain cancer. ...

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Perjeta OK’d for neoadjuvant use

Jan. 3, 2018—Genentech announced Dec. 20 the FDA’s approval of Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. People should receive the adjuvant Perjeta-based regimen for one year (up to 18 cycles). The FDA has also converted the previously granted accelerated approval of ...

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Access AMH immunoassay gets FDA OK

Dec. 29, 2017—Beckman Coulter Diagnostics announced FDA clearance for its automated Access AMH immunoassay for in vitro diagnostic use. This test aids health care providers in the assessment of a woman’s ovarian reserve and helps guide the clinical management of women struggling with infertility or planning to become pregnant later in life. The Access AMH assay is a paramagnetic particle chemiluminescent ...

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NeoGenomics to host molecular symposium

Dec. 28, 2017—NeoGenomics will host a symposium, “NGS for Clinicians and Pathologists: An Overview of Principles and Clinical Applications,” Feb. 23–24, 2018 at Laguna Cliffs Marriott Resort and Spa, Dana Point, Calif. Objectives of the symposium are to simplify next-generation sequencing for clinicians and pathologists with discussion of its advantages, disadvantages, and pitfalls; provide an introduction to NGS data analysis software ...

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Hemlibra OK’d for hemophilia A with inhibitors

Dec. 27, 2017—Genentech announced the FDA’s approval of Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors. Nearly one in three people with severe hemophilia A can develop inhibitors to factor VIII replacement therapies, putting them at greater risk for life-threatening bleeds or repeated ...

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Ortho’s Vitros ALTV Slides

Dec. 26, 2017—Ortho Clinical Diagnostics announced the launch of Vitros ALTV Slides, a new and novel method for the measurement of alanine aminotransferase, a key liver function enzyme found in serum and plasma, using dry slide technology. By using dry slide technology, Vitros ALTV Slides confer several operational and clinical advantages for the clinical laboratory and physicians, including low patient ...

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FDA expands approval of Sutent

Dec. 22, 2017—Pfizer announced the FDA has approved a new indication expanding the use of Sutent (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. The approval was based on results from the S-TRAC trial, which demonstrated a significant reduction in the risk of a disease-free survival event for ...

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Expanded FDA approval for Cellvizio

Dec. 21, 2017—Mauna Kea Technologies received expanded FDA 510(k) clearance for the Cellvizio 100 series confocal laser microscope and its Confocal Miniprobes. The expanded clearance adds indications for identification of cells and vessels and their organization or architecture. The previously cleared intended use included the fields of gastroenterology, urology, and pulmonology during endoscopic, laparoscopic manual and robot-assisted surgical, and image-guided percutaneous procedures. ...

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Horizon, Roche team up to develop IHC assays

Dec. 20, 2017—Horizon Discovery Group announced that it has entered into an agreement with Roche Diagnostics to assist in the development of immunohistochemistry assays. Under the terms of the agreement, Horizon will develop and provide reference standard material expressing neurotrophic tropomyosin receptor kinase fusion biomarkers. NTRK gene rearrangements have emerged recently as promising targets for cancer therapy, and a number ...

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