AbbVie has signed a deal worth up to $2.4 billion with the US biotech Harpoon Therapeutics, expanding a research and licensing collaboration involving technology that trains T-cells to target BCMA, a biomarker associated with multiple myeloma. The deal gives AbbVie…
Merit Medical stent graft system gains breakthrough status
Dive Brief: Merit Medical Systems has received FDA breakthrough designation for its endovascular stent graft system, the company said Thursday. The device, which Merit describes as a “flexible, self-expanding endoprosthesis” is designed to treat the narrowing of blood vessels of…
UPS plans to improve healthcare traceability with IoT-enabled logistics
Dive Brief: UPS is planning to launch a new offering for tracking healthcare-related shipments in the first quarter of next year called UPS Premier that will use Internet of Things (IoT) sensors to track packages, according to a press release…
AstraZeneca’s Calquence Wins FDA Approval for Chronic Lymphocytic Leukemia
Two months after snagging Breakthrough Therapy Designation, AstraZeneca’s Calquence wins approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The latest approval for Calquence…
Mayo’s Startup Acceleration Project Cuts Timelines Dramatically
Mayo Clinic has cut its study start up times by two-thirds, thanks to administrative restructuring, staff education and new technology. Through its Transforming the Activation of Clinical Trials (TACT) project, the clinic was able to bring study startup times down…
India closer to world’s first male contraceptive injection
The contraceptive is effective for 13 years, after which it loses its potency. It is designed as a replacement for surgical vasectomy, which is the only male sterilisation method available in the world. The Indian Council of Medical Research (ICMR)…
Coming soon: More than 750 inspectors & technicians to regulate medical devices in India
Health Minister Harsh Vardhan says Department of Expenditure has approved the creation of posts to inspect, audit and test the efficacy of medical devices. New Delhi: The Narendra Modi government is set to hire more than 700 inspectors and technicians…
Edwards recalls Pascal valve guide sheath in Europe amid potential for embolizations
Dive Brief: Edwards Lifesciences is recalling a guide sheath used with its Pascal transcatheter mitral valve repair system sold in Europe because of possible damage to the device’s inner liner due to a manufacturing issue. While no adverse events or…
FDA clears Pentax duodenoscope with disposable part in bid to cut infection risk
Dive Brief: FDA cleared the first duodenoscope with a sterile, disposable elevator component Friday in an effort to cut down on the risk of infection from reprocessing the class of devices. The marketing authorization, granted to Pentax of America, follows…
FDA approves first contact lens indicated to slow the progression of nearsightedness in children
SILVER SPRING, Md., Nov. 15, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the…
