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FDA Grants Orphan Drug Designation to Lynparza for Treatment of Pancreatic Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) for LYNPARZA for the treatment of pancreatic cancer. LYNPARZA is currently being investigated as maintenance therapy in patients with germline BRCA-mutated …

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Cannabics Announces Positive Results for Pilot Study on Treatment of Cancer Anorexia-Cachexia Syndrome

TEL AVIV, Israel and BETHESDA, Maryland, Oct. 16, 2018 /PRNewswire/ —  Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized cannabinoid medicine focused on cancer and its side effects, announced today the results of its pilot study to test the efficacy of Cannabics capsules for the treatment of cancer anorexia-cachexia …

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Genentech’s Kadcyla Reduced the Risk of Disease Recurring in People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla® (ado-trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin®(trastuzumab) …

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FDA Grants Breakthrough Therapy Designation to Loxo Oncology’s Investigational LOXO-292 for RET Fusion-Positive Thyroid Cancer

STAMFORD, Conn., Oct. 15, 2018 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion-positive thyroid …

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Bristol-Myers Squibb’s Opdivo Fails to Meet Primary Endpoint in Phase 3 Study in Patients with Relapsed Small Cell Lung Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced topline results from the Phase 3 CheckMate -331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The study did not meet its primary endpoint of …

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Bristol-Myers Squibb and Compugen Partner to Evaluate Therapeutic Regimen in Advanced Solid Tumors

NEW YORK & HOLON, Israel–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and Compugen (NASDAQ: CGEN) today announced the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Compugen’s COM701, an investigational anti-PVRIG antibody, in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab), in patients with advanced …

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Celltrion and Teva Announce FDA Advisory Committee Recommends Approval of CT-P10, a Proposed Rituximab Biosimilar

SILVER SPRING, Md. & JERUSALEM–(BUSINESS WIRE)– Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan®1 (rituximab) for the treatment of …

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Genentech to Present New Positive Data from its Broad Cancer Immunotherapy Program and Across a Wide Range of Cancers

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new results from a number of studies across its industry-leading oncology portfolio of approved and investigational medicines will be presented at the European Society for Medical Oncology (ESMO) 2018 Congress, taking …

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Veracyte Announces that New Data from Multiple Studies Demonstrate “Real World” Performance of Afirma GSC and Xpression Atlas in Thyroid Cancer Diagnosis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT) announced today that new findings from six studies reinforcing the “real world” performance of the next-generation Afirma Genomic Sequencing Classifier (GSC) and the Afirma Xpression Atlas in thyroid cancer diagnosis were presented at the 88th Annual Meeting of the American Thyroid Association (ATA). The …

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FDA Grants Orphan Drug Designation to MediciNova’s Investigational Glioblastoma Candidate

LA JOLLA, Calif., Oct. 04, 2018 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to MN-166 (ibudilast) as …

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