A new review program will be launched jointly by the FDA and the Department of Defense to expedite safety and efficacy review of medical products and devices judged to be essential for lifesaving treatments of US military personnel, with high-priority products for review to include cold-stored platelets, cryopreserved platelets and freeze-dried plasma. At least one workshop will be held by the agency and the department this year to inform FDA guidance on determining "unmet medical needs for battlefield settings," according to an initial blueprint for the initiative.
Dogs and people are prone to many of the same cancers, and clinical trials conducted in canine patients may ultimately benefit both, researchers say. Pet dogs are excellent cancer avatars not only because of their genetic similarity to people, but also because they live in the same environments we do, notes veterinarian and oncologist Douglas Thamm.
A study of opossums, rabbits, armadillos and hyraxes showed that placental mammals evolved to mute an inflammatory response to an egg implanting in the placenta, thus enabling extended gestation. Decidual cells, which form in the uterine lining early in pregnancy, persist through delivery in mice and humans but disappear quickly in many other placental mammals, suggesting that cells might moderate the inflammatory response and result in miscarriage if the process goes awry.
The FDA approved Midatech Pharma's investigational new drug application for MTX110, which is being developed as a treatment for diffuse intrinsic pontine glioma, a childhood brain cancer. The company will conduct the study at the University of California at San Francisco and Memorial Sloan Kettering Cancer Center in New York and anticipates results by the end of next year.
Spark Therapeutics' SPK-8011, which is being developed as a treatment for patients with hemophilia A, was granted orphan status by the FDA.
A supplemental biologics license application filed by Pharming for Ruconest, to be used as a prophylaxis for hereditary angioedema attacks, was accepted for review by the FDA, with a PDUFA date of Sept. 21, 2018.
The FDA granted priority review status to Novartis' Kymriah to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma. The drug also received an accelerated assessment from the European Medicines Agency for treating acute lymphoblastic leukemia in children and young adults.
Innovus Pharmaceuticals' product license application for Xyralid cream was approved in Canada for the relief of pain and symptoms caused by hemorrhoids. The company will launch the drug in the second half of the year as an over-the-counter treatment that will not require a prescription.
The CDC issued a warning about the possibility that the salmonella-linked Coconut Tree brand of frozen shredded coconut, recalled Jan. 3, could still be in people's homes, in grocery stores or used as an ingredient in restaurants because of the product's long shelf life. The product, which was recalled by Evershing International Trading, was linked to a salmonella outbreak that has sickened 26 people from nine US states and Canada.
Medtronic secured 510(k) clearance from the FDA for its Riptide aspiration system, which is designed for blood clot retrieval and blood flow restoration in patients with acute ischemic stroke secondary to intracranial large-vessel occlusive disease. The system, which includes the Medtronic Arc Catheter, Riptide Aspiration Pump, Riptide Aspiration Tubing and Riptide Collection Canister with intermediate tubing, is intended for the revascularization of patients within eight hours of the first appearance of symptoms.
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