Israeli company Enlivex, a part of Hadasit Bio-Holdings, has been awarded orphan drug status by the FDA for its product ApoCell. ApoCell is designed to treat Graft Versus Host Disease (GVHD), which affects up to 70 percent of heterologous bone marrow transplant recipients and can be lethal.
Israeli pharmaceutical giant Teva has announced that its Quartette birth-control pill has won FDA approval. The new pill has been designed to reduce breakthrough bleeding (BTB) between scheduled periods, a reason for many women’s choice to discontinue the use of the popular contraceptive.
Israeli company Brainsway Ltd., which develops innovative devices for treatment of mental disorders using magnetic pulses, has announced that it has received US Food and Drug Administration (FDA) approval for its Deep TMS system. The system uses transcranial magnetic stimulation (TMS) for treating depression in patients who cannot be treated using standard methods.
Israeli medical company Dune Medical Devices inc., has received FDA approval for its MarginProbe device, which improves results of tumor removal in breast cancer patients. Dune Medical, which was founded in 2004, has raised $30 to date and says it will continue developing other devices for the medical market.
Given Imaging Ltd., an Israeli company that develops capsuled equipped with cameras for visualization of the gastrointestinal tract, has filed with the American Food and Drug Administration (FDA) to get approval for its PillCam Colon 2 Capsule. The capsule is a complementary product for colonoscopies and has a target market of $1.7 billion.
Israeli pharmaceutical giant Teva has announced that the American Food and Drugs Administration (FDA) has granted approval for Synribo, an injectable drug for treating leukemia. The company says that the drug will soon be available for prescription.
Israeli pharmaceutical company Kamada has announced that it has received FDA approval for a phase II and III clinical trial of AATD-IH, an inhalable version of its AAT drug, which is designed to treat congenital emphysema.
The FDA has granted Israeli company Atox Bio’s tissue infection treatment AB103 fast track status. AB103 is designed to treat Necrotizing Soft Tissue Infections. The company will begin testing on 40 patients, suffering from the condition, which causes severe infection to the skin. There is currently no approved treatment for the condition.
Israeli drug companies Clal Biotech Industries and BiolineRX sign an agreement for developing and commercializing Clal’s BL-8040, a drug designed for treating acute leukemia and other types of blood cancer. The American FDA has approved the companies’ investigational new drug application.
Mazor Robotics, a developer of surgical robots, announced its Renaissance platform received FDA marketing clearance, expanding the applications of the Renaissance system to include the precise positioning of surgical instruments and implants during brain surgery. The Renaissance technology, a surgical guidance system originally designed for use in spine surgeries, is applicable in brain procedures for multiple applications, including biopsies. The company is based in Caesarea, Israel.