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Monthly Archives: June 2016

BMS Partners with PsiOxus for Late-Stage Cancer Combo Trials

NEW YORK & OXFORD, England–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and PsiOxus Therapeutics, Ltd. (PsiOxus) today announced an exclusive clinical collaboration agreement to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus’ enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with Bristol-Myers Squibb’s Immuno-Oncology (I-O) agent Opdivo (nivolumab) to treat a …

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Merrimack’s Pancreatic Cancer Regimen Maintains QOL While Improving Overall Survival in Clinical Trial

CAMBRIDGE, Mass., June 30, 2016 /PRNewswire/ — Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) today announced a newly presented analysis of the Phase 3 NAPOLI-1 data shows patients treated with ONIVYDE® (irinotecan liposome injection), also known as “nal-IRI,” in combination with fluorouracil (5-FU) and leucovorin, maintain similar baseline quality of life at …

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FDA Approves Cephed’s Carba-R Assay to Test for Genetic Markers of Drug-Resistant Bacteria

SUNNYVALE, Calif., June 30, 2016 /PRNewswire/– Cepheid (Nasdaq: CPHD) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, the first FDA-cleared test for detection of carbapenem resistance genes of multidrug resistant ‘superbugs’.  Following initial clearance in March for …

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Novartis and Xencor Enter $2.4 Billion Deal in Bispecific Antibodies

MONROVIA, Calif., June 28, 2016 /PRNewswire/ — Xencor, Inc. (Xencor) (NASDAQ:XNCR) announced today that it has entered into a collaboration and license agreement with Novartis to develop and commercialize novel therapeutics, including XmAb®14045 expected to begin clinical development for acute myeloid leukemia in 2016; and XmAb®13676 also expected to begin …

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Tesaro’s PARP Inhibitor Meets Primary Endpoint in Late-Stage Ovarian Cancer Trial

WALTHAM, Mass., June 29, 2016 (GLOBE NEWSWIRE) — TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the Phase 3 NOVA trial of niraparib successfully achieved its primary endpoint of progression-free survival (PFS). This trial demonstrated that niraparib significantly prolonged PFS compared to control among patients who are germline …

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Merck and Moderna Partner to Advance Novel Personalized Cancer Vaccines with Keytruda for Multiple Types of Cancer

KENILWORTH, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Moderna Therapeutics today announced a strategic collaboration and license agreement to develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines. The collaboration will combine Merck’s established leadership in immuno-oncology with Moderna’s pioneering …

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FDA Grants Breakthrough Therapy Designation for Imbruvica for Chronic Graft-Versus-Host-Disease

RARITAN, N.J., June 29, 2016 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy Designation (BTD) for ibrutinib (IMBRUVICA®): as monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy, Janssen Research & Development, …

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HCV: Getting the Cure to Those Who Need It

A special issue of The American Journal of Managed Care brought the topic of funding hepatitis C treatment into the spotlight: covering everything from who has access to the new treatments and what are the out-of-pocket costs, to the anticipated consequences (both economic and clinical) of not getting hepatitis C …

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FDA Approves Gilead’s Epclusa as First Pill to Treat All Forms of Hepatitis C

FOSTER CITY, Calif.–(BUSINESS WIRE)–Jun. 28, 2016– Gilead Sciences, Inc.(NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa …

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Merck Gets CHMP Positive Opinion for Keytruda as Advanced NSCLC Treatment

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of …

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