This week’s Innovation Partners Bio Blog features news and updates from Array BioPharma, Merck, Puma, and other pharmaceutical companies in this week’s BioBlog as well as updates on 340B and the new, controversial Medicaid changes, the first such changes in 53 years.
Array BioPharma Announces FDA Approval of BRAFTOVI™ (encorafenib) in Combination with MEKTOVI®(binimetinib)
The U.S. Food and Drug Administration (FDA) has approved BRAFTOVI™ capsules in combination with MEKTOVI® tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation. BRAFTOVI is made by Array BioPharma. The products are available only through selected specialty pharmacies in the United States.
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July 2: COA Supports 340B Drug Discount Accountability Act
A statement of support from the Community Oncology Association (COA) of the 340B Drug Discount Accountability Act. “COA firmly believes that the 340B Drug Discount Program is vitally important and must be maintained, for both grantees and safety-net hospitals. However, more than a decade of explosive growth in the corporate hospital sector has left a program rife with abuse. The unwitting victims are cancer patients left with less provider choice and forced to receive their care in the much more expensive hospital setting. COA has produced two important briefs on the issue, including a look at 340B program data from 25 years of research and how abuse of the program is hurting cancer patients.”
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Senate Appropriators Approve $2 Billion Increase to National Institutes of Health
The Senate Appropriations Committee approved a $2 billion funding increase to the National Institutes of Health (NIH) as part of its Fiscal Year (FY) 2019 Department of Labor, Health and Human Services (HHS), Education funding bill. The approval increase NIH funding to $39.1 billion which is a 5.4% increase over FY18 funding levels. In addition to these and other increases, the bill also approves funding for the Childhood Cancer Survivorship, Treatment, Access and Research (STAR) ACT.
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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy as First-Line Treatment for Metastatic Squamous Non-Small Cell Lung Cancer
Merck (NYSE:MRK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. In a statement taken from Merck’s press release, a company spokesperson underscored Merck’s commitment to helping boost survival rates among patients with non-small cell lung cancer
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Genetic Biomarker Linked to Improved Survival for Patients with Certain Brain Tumors
New data reported in the June 28, 2018 issue of JAMA Oncology shows that patients with MGMT methylated tumors are more than twice as likely to survive after combination temozolomide and radiation treatment than patients with unmethylated tumors. DNA-level biomarker (MGMT promoter methylation) can be used to help predict survival outcomes in patients with high-risk, low-grade gliomas. The study was conducted through the NRG Oncology/RTOG collaborative clinical trials group and led by scientists at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).
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Puma Biotechnology Receives Positive CHMP Opinion Recommending Approval of NERLYNX® for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that on June 28, 2018 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorisation for the medicinal product NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. This recommendation will now be reviewed by the European Commission.
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Kentucky’s sweeping Medicaid work requirement experiment is about to begin
Kentucky plans to launch a sweeping overhaul of its Medicaid rules. The state recently received permission to mandata work requirements. New rules require “community engagement” and a $15 per month premium for Medicaid coverage. Proponents claim this will reduce abuses of the system, while opponents say it will deny much-needed care to many people who are unable to work.
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