Industry News

FDA Approves Pembrolizumab + Chemotherapy for NSqNSCLC
On August 17, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.

Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.

Read the full FDA announcement here.

Posted 8/20/2018

FDA Approves Pembrolizumab for Treatment of PMBCL
On June 13, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.

Read the FDA press release here.

Posted 6/19/2018

Trump Administration Announces MyHealthEData Initiative
Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma has announced the administration's new MyHealthEData, an initiative that aims to give Americans more complete access to their healthcare data. She made the announcement in an address on March 6, 2018, at the Healthcare Information and Management Systems Society (HIMSS) Annual Conference in Las Vegas. The government-wide initiative is being led by the White House Office of American Innovation with participation from the Department of Health and Human Services, including CMS; Office of the National Coordinator for Health Information Technology (ONC); the National Institutes of Health; and the Department of Veterans Affairs.

As part of MyHealthEData announcement, CMS also announced that the agency intends to "overhaul" the EHR Incentive Programs to "refocus the programs on interoperability and to reduce the time and cost required" for providers to meet requirements.

In her remarks, Administrator Verma also described Medicare's Blue Button 2.0 - a tool that would allow Medicare beneficiaries to access and their personal health data in a "universal digital format."

As part of this initiative, the administration is also calling on healthcare insurers to follow suit and give patients access to their claims data in a digital format.

The administration is still developing a timeline for the initiative, Verma said in an interview with Bloomberg BNA.

Read the CMS press release.
Read the CMS fact sheet.

Posted 3/7/18

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Industry News

FDA Approves Pembrolizumab + Chemotherapy for NSqNSCLC

FDA Approves Pembrolizumab for Treatment of PMBCL

Trump Administration Announces MyHealthEData Initiative