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Monthly Archives: August 2016

The Medicines Company Provides Update on Dyslipidemia Programs

PARSIPPANY, N.J.–(BUSINESS WIRE)–The Medicines Company (NASDAQ:MDCO) today provided an update on its clinical dyslipidemia research programs for MDCO-216 (which contains APoA-1 Milano) and PCSK9si (PCSK9 synthesis inhibitor). MDCO-216. A planned, interim analysis of the first 40 randomized patients completing treatment in the MILANO-PILOT study of MDCO-216 has been reviewed by …

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Study Finds Potential New Biomarker for Cancer Patient Prognosis

To treat or not to treat? That is the question researchers at the Department of Energy’s Lawrence Berkeley National Laboratory (Berkeley Lab) hope to answer with a new advance that could help doctors and their cancer patients decide if a particular therapy would be worth pursuing. Berkeley Lab researchers identified …

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System May Help Treat Rare Genetic Disorder, Reduce Severe Side Effects

PORTLAND, Ore. – Researchers at Oregon State University and other institutions have discovered a type of drug delivery system that may offer new hope for patients with a rare, ultimately fatal genetic disorder – and make what might become a terrible choice a little easier. No treatment currently exists for …

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FDA Expands Approval of Genmab, Novartis’ Arzerra in CLL

Copenhagen, Denmark; August 31, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra®) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic …

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FDA Approves Sandoz’s Erelzi, a Biosimilar to Enbrel

Holzkirchen, August 30, 2016 – Sandoz, a Novartis division and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) approved Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) …

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FDA Accepts CSL’s BLA for First Subcutaneous Prophylactic Therapy to Prevent HAE Attacks

KING OF PRUSSIA, Pa., Aug. 30, 2016 /PRNewswire/ — CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its low-volume subcutaneous (SC) C1-Esterase Inhibitor (C1-INH) Human replacement therapy, CSL830, as prophylaxis to prevent Hereditary Angioedema (HAE) …

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Rheumatoid Arthritis: Treatment Choices

Early treatment for rheumatoid arthritis, studies show, pays off for patients in terms of long-term quality of life and a lower chance of later needing joint replacements. I can attest to this with a more personal perspective. Just yesterday I visited with my aunt who happens to have severe rheumatoid …

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CHART-1: Largest Cardiac Regenerative Therapy Trial Brings New Insights

Rome, Italy – 28 August, 2016: A therapy that uses bone-marrow stem cells to promote heart repair did not significantly improve the primary outcome over a sham procedure among patients with congestive heart failure. However, it revealed critical new insights, according to investigators of the CHART-1 trial. Although findings of …

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Walgreens and Prime Therapeutics Form Strategic Alliance Aimed at Lowering Costs and Improving Outcomes

Deerfield, Ill. and St. Paul, Minn. – Aug. 29, 2016 – Walgreens and Prime Therapeutics (Prime), a pharmacy benefit manager (PBM), today announced a long-term strategic alliance that includes a new retail pharmacy network agreement and the combination of the companies’ central specialty pharmacy and mail service businesses. The alliance …

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CTI BioPharma’s Late-Stage Study of Lead Candidate Shows Mixed Results in Advanced Myelofibrosis

SEATTLE, Aug. 29, 2016 /PRNewswire/ — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced top-line results from PERSIST-2, a randomized, controlled Phase 3 clinical trial comparing pacritinib, an investigational oral multikinase inhibitor, with physician-specified best available therapy (BAT), including ruxolitinib, for the treatment of patients with myelofibrosis …

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