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Monthly Archives: June 2017

Genentech’s Rituxan Hycela Receives FDA Approval for Treatment of Certain Blood Cancers

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved RITUXAN HYCELA™ (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or …

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FDA Rejects Pfizer’s BLA for Proposed Epoetin Alfa Biosimilar

NEW YORK, N.Y., June 22 – Pfizer Inc. (NYSE:PFE) today announced that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for its proposed epoetin alfa biosimilar. This CRL relates to matters noted in …

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FDA Approves Novartis’ Combination Targeted Therapy for BRAF V600E Mutant Metastatic NSCLC

Basel, June 22, 2017 – Novartis today announced the US Food and Drug Administration (FDA) approval of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600E mutation. The FDA granted Tafinlar + Mekinist Breakthrough Therapy designation …

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Janssen to Utilize Adaptive’s NGS-Based clonoSEQ Assay to Measure MRD in Darzalex Multiple Myeloma Trials

SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies, the leader in combining Next Generation Sequencing (NGS) and expert bioinformatics to profile T- and B-cell receptors of the adaptive immune system, announces it has partnered with Janssen Biotech, Inc. to utilize Adaptive’s NGS-based clonoSEQ Assay for measuring minimal residual disease (MRD) in patients with Multiple Myeloma …

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Sarepta and Genethon Enter Gene Therapy Research Collaboration for Duchenne Muscular Dystrophy Treatments

CAMBRIDGE, Mass. and EVRY, France, June 21, 2017 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a U.S. commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases, and Genethon, a non-profit R&D organization dedicated to the development of biotherapies for …

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Study Estimates Breast and Ovarian Cancer Risk Linked to Faulty BRCA Genes

A new study has estimated the ages at which women with faults in two particular genes are most at risk of developing breast and ovarian cancer. The research found that the highest rates of breast cancer in women with a faulty BRCA1 gene were seen between the ages of 41-50. …

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Merck Ventures and Cancer Research UK Launch New Immuno-Oncology Spin-Out Company iOnctura

Darmstadt, Germany, June 20, 2017 – Merck, a leading science and technology company, today announced its corporate venture arm Merck Ventures created iOnctura SA, Geneva, Switzerland. This immuno-oncology spin-out company was formed around two assets from the Healthcare R&D portfolio of Merck and three assets from Cancer Research Technology (CRT). …

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Cell Medica Acquires Catapult Therapy for WT1 Cancer Immunotherapy Candidate

LONDON–(BUSINESS WIRE)–Cell Medica today announced the acquisition of Catapult Therapy TCR Limited, a subsidiary of Cell and Gene Therapy Catapult (CGT Catapult), and the initiation of a collaboration to establish cell therapy manufacturing for Cell Medica at CGT Catapult’s GMP manufacturing facility in Stevenage, UK. Financial terms were not disclosed. …

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Novartis’ Wet AMD Drug Meets Primary and Key Secondary Endpoints in Two Late-Stage Studies

Basel, June 20, 2017 – Novartis, the global leader in Ophthalmology, today reported that RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER. RTH258 3 mg, evaluated in HAWK, also met these endpoints. These pivotal studies enrolled more than 1,800 …

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New Three-In-One Blood Test Opens Door to Precision Medicine for Prostate Cancer

Scientists have developed a three-in-one blood test that could transform treatment of advanced prostate cancer through use of precision drugs designed to target mutations in the BRCA genes. By testing cancer DNA in the bloodstream, researchers found they could pick out which men with advanced prostate cancer were likely to …

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