Bionest

Long Awaited CMS Rules on Medicare Coverage for CAR-T Therapies

In August, the Centers for Medicare and Medicaid Services (CMS) finalized long-sought rules framing the coverage of chimeric antigen receptor T-cell (CAR-T) treatments. Two CAR-T therapeutics are currently on the market: Gilead’s Yescarta and Novartis’ Kymriah, both approved for diffuse large B-cell lymphoma (DLBCL) with the latter also approved for acute lymphocytic leukemia (ALL). Under...

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New Strategies Against a Hard-to-Treat Killer — Pancreatic Cancer

Pancreatic cancer was the third leading cause of cancer-related death in the United States in 2018. This year, experts estimate that 56,770 new cases will be diagnosed and 45,750 deaths will be recorded. Pancreatic cancer is especially lethal because in its early stages, when the disease is easiest to treat, patients are usually asymptomatic. The disease...

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Expanding the CRISPR Toolbox for New Healthcare Applications

CRISPR/Cas9 was first successfully demonstrated as a tool for genome editing in human cells in 2013.  Since then, several advances have enabled the use of this technology to shut down a faulty gene, change a single DNA letter in a gene sequence, or add a new gene to an existing genome sequence. This summer has...

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New Approvals for Tumor-Agnostic Cancer Treatments — and the Questions They Raise

On August 15, the U.S. Food and Drug Administration granted accelerated approval to Genentech/Roche’s Rozlytrek (entrectinib) for the treatment of adult and adolescent patients with solid tumors that exhibit neurotrophic tyrosine receptor kinase (NTRK) fusions and for whom there are no existing effective treatments. While NTRK fusions are rare, appearing in about 1% of solid...