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Monthly Archives: June 2017

Liquid Biopsies: A Non-Invasive Look at Treatment Response

Barcelona, Spain, 30 June 2017 – A new study, to be presented at the ESMO 19th World Congress on Gastrointestinal Cancer, shows that so-called “liquid biopsies”, blood tests that detect circulating tumor DNA (ctDNA), may not only sound an early alert that a treatment’s effect is diminishing, but may also …

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Amgen’s Vectibix Receives Expanded Approval for Use in Wild-Type RAS Metastatic Colorectal Cancer

THOUSAND OAKS, Calif., June 29, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vectibix® (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test …

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FDA Approves Triptodur for Treatment of Patients 2 Years and Older with Central Precocious Puberty

ATLANTA and LAUSANNE, Switzerland, June 30, 2017 /PRNewswire/ — Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, and Debiopharm International SA, part of Debiopharm Group™, a Swiss-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Triptodur™ for the treatment of pediatric patients 2 …

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Cannabics Pharmaceuticals Receives Positive Results in Drug Sensitivity Tests on CTCs

TEL AVIV, Israel, June 30, 2017 /PRNewswire/ — Cannabics Pharmaceuticals Inc. (CNBX) today announced it received positive results from screening necrosis (cell death) of circulating tumor cells, from cancer patients, treated with the cannabinoids CBD and CBDA. These results greatly strengthen the company’s previously accumulated data on cannabinoid anti-tumor activity. …

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Illumina Granted FDA Approval for Next-Generation Sequencing Cancer Companion Diagnostic Test Kit

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ:ILMN) today announced its Extended RAS Panel, an FDA-approved next-generation sequencing (NGS) kit that meets the newly published guidelines for evaluation of colorectal cancer from the American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the …

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AstraZeneca and Chi-Med Initiate Phase 3 Trial in Papillary Renal Cell Carcinoma

London: Thursday, June 29, 2017: Chi-Med and AstraZeneca today announce that they have initiated a global pivotal Phase III, open-label, randomized multi-center registration study of the highly selective inhibitor of c-MET receptor tyrosine kinase, savolitinib, in c-MET-driven papillary renal cell carcinoma (“PRCC”).  This is the first pivotal study ever conducted …

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Pfizer Enters Feasibility Study Agreement Evaluating Alcyone’s Pulsar Technology for Use in Gene Therapy Targeting CNS Disorders

LOWELL, Mass., June 29, 2017 /PRNewswire/ — Alcyone Lifesciences, Inc., a leader in precision advanced central nervous system (CNS) delivery systems announced that it has entered into a feasibility study agreement with Pfizer Inc. (NYSE: PFE) in the area of genetic therapy targeting rare and orphan neurological disorders. The feasibility …

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Walgreens Boots Alliance Scraps Rite Aid Merger Agreement, Will Buy Stores Instead

DEERFIELD, Ill.–(BUSINESS WIRE)–Walgreens Boots Alliance, Inc. (Nasdaq: WBA) announced today a new definitive agreement with Rite Aid Corporation under which Walgreens Boots Alliance will purchase 2,186 stores, three distribution centers and related inventory from Rite Aid. The consideration for the transaction will be $5.175 billion in cash, the assumption by …

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Celltrion and Teva Announce FDA Acceptance of BLA for Proposed Biosimilar to Rituxan

INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE)–Celltrion, Inc., a global biopharmaceutical company, and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CT-P10, a proposed Monoclonal Antibody (mAb) biosimilar to Rituxan®1 (rituximab), …

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FDA Unveils Plan to Eliminate Orphan Designation Backlog

Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to …

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