Friday , November 17 2017
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Nicole Watkins

CMS Proposes Policies to Lower the Cost of Prescription Drugs and Combat the Opioid Crisis

Today, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that includes a number of changes that, if finalized, will ensure that Part D Medicare enrollees have access to more affordable prescription drugs and more robust prescription drug coverage at the pharmacy they prefer. The rule also …

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Cue Biopharma Enters Strategic Research Collaboration and License Agreement with Merck

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Cue Biopharma™, Inc., an immunotherapy company developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system to treat cancer and autoimmune diseases, today announced a strategic research collaboration and license agreement with Merck, known as MSD outside of the United States and Canada. …

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Amgen Launches the Enbrel Mini Reusable Autoinjector That is Ergonomically Designed for Patients

THOUSAND OAKS, Calif., Nov. 17, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) announced that the ENBREL Mini™ with AutoTouch™ is now available in the United States (U.S.). Awarded the Arthritis Foundation Ease of UseSM Commendation, this new and innovative delivery system provides an additional administration option for appropriate ENBREL patients. The …

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Pfizer’s Sutent Receives FDA Approval for Patients at High Risk of Recurrent Renal Cell Carcinoma

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration has approved a new indication expanding the use of SUTENT® (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous …

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FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II …

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NYU Stern Study Shows Significant Health Improvement in Diabetes Patients with Mobile Health Applications

NEW YORK–(BUSINESS WIRE)–New research “Empowering Patients Using Smart Mobile Health Platforms: Evidence from a Randomized Field Experiment,” from NYU Stern Professor Anindya Ghose and co-authors, Beibei Li of Carnegie Mellon University and Xitong Guo of the Harbin Institute of Technology, explores how emerging mobile health (mHealth) technologies can persuade chronic-disease patients to …

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Genentech’s Hemlibra Receives FDA Approval for Treatment of Hemophilia A with Inhibitors

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved HEMLIBRA® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor …

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Celgene and bluebird bio Announce the FDA Granted Breakthrough Therapy Designation to CAR-T Cell Therapy

SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) and bluebird bio, Inc. (NASDAQ:BLUE) today announced that bb2121, a chimeric antigen receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration …

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FDA Unveils a Streamlined Path for the Authorization of Tumor Profiling Tests Alongside its Latest Product Action

The U.S. Food and Drug Administration today authorized Memorial Sloan Kettering Cancer Center’s (MSK) IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test (assay), an in vitro diagnostic test that can identify a higher number of genetic mutations (biomarkers) that may be found in various cancers than any …

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Alnylam Starts Rolling FDA Filing for Patisiran for the Treatment of Hereditary ATTR

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the company has initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR), for the treatment of hereditary ATTR (hATTR) amyloidosis. …

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