Online Exclusives

Online Exclusives

FDA Struggles to Hire Overseas Drug Facility Inspectors

From 2016 to 2018, the FDA’s overseas drug facility inspections decreased by about 10%, in part because the agency has struggled to hire new...

Moffitt Officials Resign After Investigation Reveals Disclosure Problems Related To Chinese Researchers

Six officials and researchers from the H. Lee Moffitt Cancer Center in Tampa, Florida, have resigned amid a controversy related to research collaboration with...

Few Americans Understand FDA Approvals

According to survey results published in Pharmacoepidemiology & Drug Safety, only a quarter of Americans understand that FDA approval of a drug does not...

Fewer Americans Have Primary Care Providers

Fewer Americans had a primary care provider in 2015 than in 2002, according to a report published in JAMA Internal Medicine. The overall proportion...

FDA Approves Zanubrutinib for Relapsed/Refractory Mantle Cell Lymphoma

The FDA has granted accelerated approval to zanubrutinib, an inhibitor of Bruton tyrosine kinase (BTK), to treat adults with mantle cell lymphoma who have...
Sickle cell anemia

Crizanlizumab-tmca Becomes First Approved Targeted Therapy for Sickle Cell Disease

The FDA approved crizanlizumab-tmca to reduce the frequency of vaso-occlusive crisis in patients aged 16 and older with sickle cell disease (SCD). The agent...

Gene Editing Therapy Shows Early Benefit for Patients With SCD and Beta Thalassemia

CRISPR Therapeutics and Vertex Pharmaceuticals have reported that the first two patients to receive an experimental gene editing treatment for SCD and beta thalassemia...

Hospital Spending on Cancer Immunotherapies Has Increased

An analysis by research and analytics firm Lumere found that a greater share of hospitals’ budgets is going toward new cancer treatments and a...

Stephen Hahn Confirmed as FDA Commissioner

The Senate voted 72−18 to confirm Stephen Hahn, MD, as FDA commissioner. President Donald Trump nominated Dr. Hahn, an oncologist and chief medical executive at...

Trump Administration Considers Easing USMCA Biologic Drug Protections

To win Democratic support for a trade deal with Mexico and Canada, the Trump administration is considering easing intellectual property protections for large drug...
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Current Issue

February 2020, Volume 6, Issue 3

This issue examines the high price of treating hemophilia, asks whether CAR T-cell therapies are worth the cost, and more.