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Monthly Archives: April 2017

Takeda and Harrington Collaborate for Development of Rare Disease Drugs

Osaka, Japan and Cleveland, Ohio, USA – 27 April 2017 – Takeda Pharmaceutical Company Limited (TSE: 4502), and Harrington Discovery Institute at University Hospitals in Cleveland, Ohio have announced a multi-year collaboration to accelerate breakthrough therapeutic discoveries in rare diseases. A first of a kind partnership for Harrington Discovery Institute …

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New Research Suggests Current Genetic Testing Guidelines May Miss Breast Cancer Patients who Could Benefit from Testing

LAS VEGAS, April 28, 2017 /PRNewswire/ — New research suggests that current clinical guidelines on the use of genetic testing in breast cancer patients are too narrow and allow patients with pathogenic variants to be missed. The findings were presented at the American Society of Breast Surgeons (ASBS) Annual Meeting …

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FDA Approves Novartis’ Rydapt for Treatment of Patients with Acute Myeloid Leukemia

SILVER SPRING, Md., April 28, 2017 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with …

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Tracking Unstable Chromosomes Helps Predict Lung Cancer’s Return

Scientists have found that unstable chromosomes within lung tumors increases the risk of cancer returning after surgery, and have used this new knowledge to detect relapse long before standard testing. These are the first findings from the Cancer Research UK-funded TRACERx* lung cancer study, published today (Wednesday) in the New …

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Pfizer’s Lorlatinib Receives Breakthrough Therapy Designation from the FDA for ALK-Positive NSCLC

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. today announced that its investigational next-generation ALK/ROS1 tyrosine kinase inhibitor, lorlatinib, was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more …

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FDA Expands Approval of Bayer’s Stivarga for Treatment of Hepatocellular Carcinoma

The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer in almost a decade. “Limited …

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FDA Approves Biomarin’s Brineura as the First Treatment for a Form of Batten Disease

SAN RAFAEL, Calif., April 27, 2017 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that the U.S. Food and Drug Administration (FDA) approved Brineura™ (cerliponase alfa) to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), …

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New Data from Genzyme’s Phase 3 Study Suggest Positive Effects of Aubagio on Cortical Gray Matter Atrophy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that new investigational data evaluating the effect of Aubagio® (teriflunomide) on cortical gray matter atrophy in patients with a first clinical episode suggestive of MS will be presented at the 69th American Academy of Neurology (AAN) …

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Samsung Bioepis’ Biosimilar Version of Remicade Receives FDA Approval

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS™ (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, RENFLEXIS™ is indicated for reducing signs and symptoms in patients with adult and …

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The Medicines Company and Alnylam Announce Agreement with FDA on Phase 3 Program for Inclisiran

PARSIPPANY, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–The Medicines Company (NASDAQ:MDCO) and Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) today announced that The Medicines Company has agreed with the U.S. Food and Drug Administration (FDA) on plans for the Phase III clinical program for inclisiran, which is designed to support the submission of a New …

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