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Janssen announces submission of IMBRUVICA sNDA to FDA for WM treatment

Janssen announces submission of IMBRUVICA sNDA to FDA for WM treatment

Janssen Research & Development, LLC today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) to the U.S. Food and Drug Administration by its strategic partner Pharmacyclics, Inc. [More]
Mental stress affects women's hearts more than men's

Mental stress affects women's hearts more than men's

Researchers have known for decades that stress contributes to heart disease. But a new analysis by researchers at Duke Medicine shows mental stress may tax women's hearts more than men's. [More]
New surface coating for medical devices prevents blood from clotting

New surface coating for medical devices prevents blood from clotting

From joint replacements to cardiac implants and dialysis machines, medical devices enhance or save lives on a daily basis. However, any device implanted in the body or in contact with flowing blood faces two critical challenges that can threaten the life of the patient the device is meant to help: blood clotting and bacterial infection. [More]
Case Western Reserve researcher lands Director's New Innovator Awards from NIH

Case Western Reserve researcher lands Director's New Innovator Awards from NIH

For the second consecutive year, a Case Western Reserve University School of Medicine researcher has landed one of the year's much-coveted Director's New Innovator Awards from the National Institutes of Health. Principal investigator Rong Xu, PhD, assistant professor of medical informatics, will receive $2,377,000 for five years, starting immediately, to initiate computational analysis of thousands of drugs and their effects. [More]
Aptose joins Beat AML research collaboration

Aptose joins Beat AML research collaboration

Aptose Biosciences Inc., a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, the Knight Cancer Institute at Oregon Health & Science University and The Leukemia & Lymphoma Society today announced that Aptose has joined the Beat AML collaboration. [More]
Amgen seeks FDA approval for leukemia drug blinatumomab

Amgen seeks FDA approval for leukemia drug blinatumomab

Amgen today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. [More]
Studies explore role of STXBP5 gene in development of cardiovascular disease

Studies explore role of STXBP5 gene in development of cardiovascular disease

Two independent groups of researchers led by Sidney (Wally) Whiteheart, PhD, of the University of Kentucky, and Charles Lowenstein, MD, of the University of Rochester, have published important studies exploring the role that a gene called STXBP5 plays in the development of cardiovascular disease. [More]
Synthetic platelet-like particles could augment natural blood clotting for treatment of traumatic injuries

Synthetic platelet-like particles could augment natural blood clotting for treatment of traumatic injuries

A new class of synthetic platelet-like particles could augment natural blood clotting for the emergency treatment of traumatic injuries - and potentially offer doctors a new option for curbing surgical bleeding and addressing certain blood clotting disorders without the need for transfusions of natural platelets. [More]
FDA approves use of Imbruvica to treat patients with chronic lymphocytic leukemia

FDA approves use of Imbruvica to treat patients with chronic lymphocytic leukemia

The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use. [More]
Scientists develop next-generation platelet bioreactor to generate functional human platelets

Scientists develop next-generation platelet bioreactor to generate functional human platelets

Scientists at Brigham and Women's Hospital (BWH) have developed a scalable, next-generation platelet bioreactor to generate fully functional human platelets in vitro. The work is a major biomedical advancement that will help address blood transfusion needs worldwide. [More]
Rigel initiates Phase 3 clinical program for fostamatinib in patients with ITP

Rigel initiates Phase 3 clinical program for fostamatinib in patients with ITP

Rigel Pharmaceuticals, Inc. today announced the initiation of a Phase 3 clinical program for its oral SYK inhibitor, fostamatinib, in patients with ITP (immune thrombocytopenic purpura). [More]
Mitek Sports Medicine expands early intervention options for sports medicine physicians and patients

Mitek Sports Medicine expands early intervention options for sports medicine physicians and patients

Mitek Sports Medicine, a leader in orthopaedics sports medicine and a part of the DePuy Synthes Companies of Johnson & Johnson, announced the launch of MONOVISC High Molecular Weight Hyaluronan, a single-injection treatment for knee pain related to osteoarthritis and the PEAK Platelet Rich Plasma (PRP) System, a new device that produces high quality PRP in only 2.5 minutes. [More]

Cerus enters into $30M growth capital credit facility with Oxford Finance

Cerus Corporation announced today that it has entered into a $30 million growth capital credit facility with Oxford Finance LLC. [More]
FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval. [More]
Incyte’s ruxolitinib Phase III study for polycythemia vera achieves primary endpoint

Incyte’s ruxolitinib Phase III study for polycythemia vera achieves primary endpoint

Incyte Corporation (Nasdaq: INCY) today announced results from the RESPONSE trial, the first pivotal Phase III study evaluating a JAK1/JAK2 inhibitor for the treatment of polycythemia vera (PV). [More]
P2Y12 and blood clotting: an interview with Dr. Jacobson, NIH

P2Y12 and blood clotting: an interview with Dr. Jacobson, NIH

We already understand the many steps involved in blood clotting in great mechanistic detail. The process of blood vessels closing off in response to injury is necessary for preserving life, but blood platelets that are over-active, or activated inappropriately because of unstable plaque, can lead to heart attacks and strokes. [More]
Promedior reports positive preliminary data from PRM-151 Phase 2 trial for myelofibrosis

Promedior reports positive preliminary data from PRM-151 Phase 2 trial for myelofibrosis

Promedior, Inc., today announced positive preliminary data from its Phase 2 trial of PRM-151, an anti-fibrotic immunotherapy, in patients with myelofibrosis which demonstrated biologic activity with improvements across clinically relevant measures, including bone marrow fibrosis, hemoglobin, platelets, spleen, and symptoms. [More]
PGFX Patent Holdings acquires proprietary methods, devices, intellectual property from Orogen Biosciences

PGFX Patent Holdings acquires proprietary methods, devices, intellectual property from Orogen Biosciences

On Friday, April 18th PGFX Patent Holdings, operating as Heritage Biosciences, LLC made an asset acquisition of proprietary methods, devices and intellectual property from Orogen Biosciences, Inc. [More]
New understanding of toxicity levels of chemotherapy regimens used for early stage breast cancer

New understanding of toxicity levels of chemotherapy regimens used for early stage breast cancer

Oncologists now have a new understanding of the toxicity levels of specific chemotherapy regimens used for women with early stage breast cancer, according to research from The University of Texas MD Anderson Cancer Center. [More]
Recycling patients' red blood cells during heart surgery better than banked blood transfusion

Recycling patients' red blood cells during heart surgery better than banked blood transfusion

Patients whose own red blood cells are recycled and given back to them during heart surgery have healthier blood cells better able to carry oxygen where it is most needed compared to those who get transfusions of blood stored in a blood bank, according to results of a small study at Johns Hopkins. [More]