In this week’s Innovation Partners BioBlog, we feature updates on many important stories from the world of healthcare. The FDA is reviewing their 40-year old fast-track process with the goal of updating it to improve medical device safety review procedures. Small, independent hospitals have found a new way to remain solvent without merging with large hospital chains: participate in drug trials. This and more in this week’s Innovation Partners BioBlog.
FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion(1,2)
The FDA has approved Vitrakvi® (larotrectinib), the first ever oral TRK inhibitor, for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. While TKR fusions are rare, but are found among many cancer types.
ASH 2018: A Guide to the Latest for Blood-Borne Cancers and More
San Diego will host the annual American Society of Hematology conference, the largest U.S. medical gathering to get the latest on blood diseases, and a venue for updates on some of the most cutting-edge biotechnologies that only a few years ago seemed like science fiction. Studies focused on five types of cancer will be the focus of ASH this year. The conference will focus on leukemia/lymphoma, multiple myeloma, beta-thalassemia, hemophilia, and sickle cell disease.
FDA to overhaul more than 40-year-old process for approving medical devices that some say puts consumers at risk
The FDA plans to overhaul the 510(k) medical device approval process, a move which consumer advocates say is long overdue. Since 1976, manufacturers have been able to pursue an expedited approval process. However, with cases of medical device injuries on the rise, some question the wisdom of fast-tracking all devices. New products entering the market, for example, are compared to older ones, sometimes products that are decades old. The FDA plans to finalize its guidance on establishing an alternative accelerated pathway early next year.
Trump Administration Invites Health Care Industry to Help Rewrite Ban on Kickbacks
The Trump Administration has asked for recommendations to ease the ban on kickbacks, a move which surprises many following the administration’s moves in the field of healthcare. The goal is to open pathways for doctors and hospitals to work together to improve care and save money. The challenge will be to accomplish that without also increasing the risk of fraud. Right now, the move appears to have unleashed a frenzy of lobbying activity.
CVS-Aetna deal scheduled to close this week after getting final regulatory nod
The CVS-Aetna deal is expected to close within the week, despite delays forced by New York and New Jersey’s failure to greenlight the deal before Thanksgiving. The $69 billion merger has been under scrutiny for months as the Department of Justice and other watchdog groups examined all aspects to ensure fair competition in the marketplace.
Walgreens partnership would give Humana more leverage in shifting market
Rumors are swirling that Walgreens and Humana are looking to cut a deal to take equity stakes in one another, a move which would help the two remain competitive in the atmosphere of vertical integration. With the CVS-Aetna deal expected to close very soon, Walgreens and Humana are looking to remain competitive in a market that’s changing with each passing day.
Small Hospitals Partner With Large Drug Companies for Mutual Benefits
Regional hospitals are increasingly participating in drug trials. Smaller hospitals, eager for financial contributions, are partnering with drug companies in drug trials. The money that comes from drug trials helps defray the cost of supplies, administrative costs and more at smaller hospitals, while drug companies can access more patients for trials. Many smaller hospitals must merge with larger hospital chains in order to keep their doors open. By participating in drug trials, they retain autonomous thanks to drug companies’ lucrative financial contributions.