European and U.S. drug regulators are looking into whether a defective blood clotting test device affected a trial involving Bayer’s top-selling anti-clotting drug Xarelto, hitting the German drugmaker’s shares. The study compared Xarelto, also known as rivaroxaban, with older drug warfarin for preventing strokes in patients with a type of irregular heartbeat common among the […]
FDA approves Baxalta’s treatment for common bleeding disorder
Approvals, Biotech, Bleeding, Bleeding Disorders, Blood Clots, Blood Clots, FDA, FDA/Regulatory, gegetic, Genetic Engineering, Genetics, Health, Hemophilia, Hemophilia, Immune Systems, Joints, Muscles, Oncology, Orphan Diseases, Orphan Drugs, Proteins, Rare Diseases, Shares, Shares, Willebrand DiseaseThe U.S. Food and Drug Administration on Tuesday approved Baxalta Inc’s Vonvendi, making it the first engineered protein-based treatment for the world’s most common inherited bleeding disorder. Vonvendi treats Willebrand disease, which is caused by the deficiency or defect in von Willebrand factor, a protein that is critical for blood clotting. The disease affects about […]
The U.S. Food and Drug Administration said on Friday it approved Baxalta Inc’s drug for use in patients with a type of rare bleeding disorder. The drug, Adynovate, was approved to control and reduce the frequency of bleeding episodes in patients with Hemophilia A, the agency said in a statement. Data from a late-stage study, […]
A drug developed by Portola Pharmaceuticals to rapidly reverse the effect of new blood thinning agents in cases of major bleeding or other emergencies proved highly effective in a late stage study, according to data presented on Wednesday that should help make the case for its approval. Portola’s andexanet alfa reversed the anticoagulant effect of […]
(Reuters Health) – Basketball players could be at heightened risk for dangerous blood clots that travel to the lungs, according to a small Spanish study. But the results – calculated from only six cases of so-called pulmonary embolism in U.S. and European players – need to be replicated in larger studies, the authors caution. “We […]
Roche said on Friday it had won breakthrough therapy designation from the U.S. Food and Drug Administration for an experimental hemophilia medicine, aiming for a piece of the $11 billion hemophilia drug market. The Swiss drugmaker said its U.S.-based Genentech unit’s ACE910 secured the fast-track designation as the company prepares separate Phase III trials […]
AstraZeneca Plc on Thursday said the U.S. Food and Drug Administration approved a new dose of its blood thinner Brilinta intended for longer-term use in patients with a history of heart attack or a condition known as acute coronary syndrome. The FDA approved Brilinta tablets at a new 60 milligram dose that would be taken […]
Artificial Blood Vessels Become Resistant To Thrombosis Scientists from ITMO University developed artificial blood vessels that are not susceptible to blood clot formation. The achievement was made possible by a new generation of drug-containing coating applied to the inner surface of the vessel. The results of the study were published in the Journal of Medicinal […]
Eli Lilly & Co.’s experimental lung cancer drug necitumumab improved overall survival by an average of 1.6 months but also increased the risk of sometimes fatal blood clots, according to a preliminary review by the U.S. Food and Drug Administration. The FDA’s review was posted on its website on Tuesday ahead of July 9 meeting […]