Miscellaneous Hematological Agents

'Groundbreaking' Technology Heals Serious Injuries with a Single Touch

By August 09, 2017

"By using our novel nanochip technology, injured or compromised organs can be replaced. We have shown that skin is a fertile land where we can grow the elements of any organ that is declining," said Dr. Chandan Sen.

FDA Grants Zelboraf Priority Review for Rare Blood Disease

By August 07, 2017

The application includes data from the open-label, Phase 2 VE-BASKET study; non-randomized, basket study investigating the use of Zelboraf in patients with BRAF V600 mutation-positive cancers and other diseases, including 22 patients with ECD.

FDA Approves New Sickle Cell Disease Treatment

By July 07, 2017

The safety and efficacy of Endari were evaluated in a randomized clinical trial involving patients aged 5-58 years with sickle cell disease who had ≥2 painful crises within 12 months prior to trial enrollment.

Novel Synthetic Bio Drug for Hyperammonemia Granted Fast Track

By June 26, 2017

Synthetic Biotic medicines utilize synthetic biology to reprogram probiotic bacteria to perform critical functions that compensate for those missing or damaged due to a particular disease.

Dosing Errors Common with Certain Blood-Thinning Medications

June 06, 2017

Study of newer medications finds 16 percent receive too much or too little

Mepolizumab Evaluated in Eosinophilic Vasculitis

May 26, 2017

The researchers found that, compared with placebo, mepolizumab treatment correlated with significantly more accrued weeks of remission.

New Formulation of Jadenu Approved

By May 22, 2017

Both the tablets and granules should not be taken with aluminum-containing antacid products. The drug labeling contains additional information for patients who are on current chelation therapy with Exjade (deferasirox) tablets for oral suspension and converting to Jadenu.

Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis

By May 18, 2017

Wechsler, ME et al. "Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis". DOI: 10.1056/NEJMOA1702079

Delaying Anticoagulation Tx in Afib May Increase Dementia Risk

May 15, 2017

Even patients with a low risk of stroke could benefit, researchers say

Blood Type May be Factor in Heart Attack Risk

By May 02, 2017

The odds ratio for all coronary events and combined cardiovascular events was found to be significantly higher in carriers of a non-O blood group.

Rydapt Approved for Acute Myeloid Leukemia, Mastocytosis

By April 28, 2017

Rydapt works by inhibiting multiple receptor tyrosine kinases.

FDA Approves Test for Suspected Polycythemia Vera Evaluation

By April 07, 2017

The ipsogen JAK2 RGQ PCR Kit test detected polycythemia vera with 94.6% sensitivity and 98.1% specificity, in the study the approval was based on.

DAPT Cessation Significantly Lower in Diabetic Patients

March 29, 2017

Risk of major adverse cardiovascular events up for DAPT disruption, regardless of diabetes status

Levosimendan Treatment Assessed in Post-Cardiac Sx Patients

March 24, 2017

"In patients who required perioperative hemodynamic support after cardiac surgery, low-dose levosimendan in addition to standard care did not result in lower 30-day mortality than placebo," the authors write.

ASA Hyporesponsiveness After CABG May Be Overcome by Multiple Dosing

March 22, 2017

Multiple dosing more effective than ASA 81 or 325 mg once-daily for suppressing serum TXB2 formation

FDA Fast Tracks Recombinant ADAMTS13 Enzyme Replacement Therapy

By March 22, 2017

Shire announced that the FDA has granted Fast Track designation to SHP655 (historically BAX930) for the treatment of acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP) in patients with a constitutional ADAMTS13 deficiency.

Stem Cell Transplant Cures First Adult Patient of Rare Blood Disorder

By March 21, 2017

The patient underwent a non-myeloablative (NMA) peripheral blood stem cell transplant from a 10/10 HLA Ag matched, ABO incompatible unrelated donor.

Risks Following RFA for Liver Cancer in ESRD Patients on Hemodialysis Investigated

March 20, 2017

Dialyzed patients have higher in-hospital mortality, hemorrhagic complications after RFA for HCC

FDA Grants Orphan Drug Status to MDS Biologic

By March 09, 2017

Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to BI 836858 for the treatment of myelodysplastic syndromes (MDS).

Alexion Seeks Eculizumab Approval for Ultra-Rare Neuromuscular Disease

By March 08, 2017

The submission is supported by data from the Phase 3 REGAIN study, a randomized, double-blind, placebo-controlled trial which enrolled a total of 125 patients with anti-AChR Abs.

Predictors of Critical Limb Ischemia Readmission ID'd

March 07, 2017

Most readmissions are unplanned; index hospitalization LOS linked to unplanned readmission

Antithrombotic Drug Use Ups Subdural Hematoma Risk

March 01, 2017

Highest odds of subdural hematoma for combined use of vitamin K antagonist and antiplatelet drug

FDA Approves Test to Help Clinicians Make Antibiotic Treatment Decisions

By February 24, 2017

High levels of PCT suggest a patient has a bacterial infection.

Revlimid Approved as Maintenance Therapy in Multiple Myeloma

By February 23, 2017

Adverse events seen in these trials were similar to those previously described in the lenalidomide product labeling.

FDA Grants Priority Review to Antibody-Drug Conjugate for ALL

By February 21, 2017

The BLA submission is based on positive data from the INO-VATE 1022 study, a Phase 3 trial evaluating inotuzumab ozogamicin vs. standard of care chemotherapy in 326 adults with relapsed or refractory B-cell ALL.

NOAC Prescribing Up in Afib But Many Still Undertreated

February 14, 2017

Non-vitamin K antagonist oral anticoagulants prescribed more often than vitamin K antagonists

Imbruvica Gains New Indication for Marginal Zone Lymphoma

By January 19, 2017

The Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib; Janssen and Pharmacyclics) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received ≥1 prior anti-CD20-based therapy.

New Year Detox May Have Triggered Life-Threatening Complication

By January 12, 2017

The 47-year-old previously fit woman presented to the hospital following a short period of confusion and repetitive behavior.

FDA Should Reduce Max Storage Limit of RBCs, Say Researchers

By January 10, 2017

A group of researchers are asking the Food and Drug Administration (FDA) to reduce maximum storage limit for red blood cells from 6 weeks to 5 weeks, as long as there are sufficient blood supplies available.

Does Diabetes Infringe on Myocardial Proangiogenic Response?

January 10, 2017

The amplitude of therapeutic revascularization associated with recombinant adeno-associated virus (rAAV) (5 × 1012 viral particles encoding thymosin beta 4 [Tβ4]) is reduced with diabetes mellitus