Latest & Greatest

Latest & Greatest

Recent developments in the field of hematology/oncology, including drug approvals, policy updates, and clinical trial results

HHS Issues Final Rule on Protecting Human Subjects in Research

Monday, March 13th, 2017
The U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule to update regulations regarding the use...

FDA Emphasizes Need for Phase III Clinical Trials

Monday, March 13th, 2017
A report issued by the FDA noted discrepancies between phase II and phase III drug trials, emphasizing the need for appropriate – and sometimes...

FDA Grants Ibrutinib Accelerated Approval for Marginal Zone Lymphoma

Monday, March 13th, 2017
The U.S. Food and Drug Administration (FDA) granted accelerated approval to ibrutinib for marginal zone lymphoma (MZL) following at least one prior anti-CD20-based therapy. The...

FDA Places Hold on Investigational Anemia Treatment

Friday, March 10th, 2017
The FDA has placed a clinical hold on further investigation of AG-519 – an oral pyruvate kinase-R activator for the treatment of anemia –...

FDA Grants Breakthrough Designation for JCAR017 for the Treatment of Non-Hodgkin Lymphoma

Friday, March 10th, 2017
The FDA granted breakthrough therapy designation for JCAR017 – a CD19-targeted chimeric antigen receptor (CAR) T-cell therapy – for patients with relapsed/refractory, aggressive large...

FDA Lifts Clinical Hold on Pacritinib for the Treatment of Myelofibrosis

Friday, March 10th, 2017
The U.S. Food and Drug Administration (FDA) has lifted the full clinical hold placed on all clinical trials of pacritinib – an oral kinase JAK2/FLT3 inhibitor...

DEA Revises Registration Renewal Process … Twice

Friday, March 10th, 2017
In November 2016, the U.S. Department of Justice’s Drug Enforcement Administration (DEA) announced significant changes to its registration renewal process effective January 1, 2017....

AMA Announces Support for Value-Based Pricing

Friday, March 10th, 2017
The American Medical Association (AMA) voiced its support for value-based drug pricing in an initiative that “ at changing the fundamentals of prescription drug...

Mixed Results for Fostamatinib in Studies of Immune Thrombocytopenia

Friday, March 10th, 2017
Data from two double-blind studies of the SYK inhibitor fostamatinib in adult patients with chronic/persistent immune thrombocytopenia (ITP) showed disparate results. Combined data, however,...

FDA Approves Daratumumab Combination for Multiple Myeloma

Friday, March 10th, 2017
The FDA approved daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for patients with multiple myeloma who have received at least...
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Current Issue

March 2017, Volume 3, Issue 4

This issue takes a look at diversity in the medical education system, provides a hematology drug pipeline update, and more.