Progress on new pump hardware, a wider age indication for its new insulin dosing algorithm, and the ability to control dosing from a phone app are among Tandem Diabetes’ focuses for 2020, execs outlined on an earnings call Monday. Annual…
LivaNova loops Verily into depression device study
Dive Brief: As part of an ongoing clinical trial of its implanted vagus nerve stimulation (VNS) system in people with hard-to-treat depression, LivaNova is partnering with Verily to offer a wearable device and mobile app meant to help gather additional information…
FDA posts trio of medical device warning letters
Dive Brief: FDA has issued a flurry of warning letters against medical device companies shortly after an agency official predicted an uptick in enforcement activity. The number of medical device warning letters issued annually fell almost 90% from 2015 to 2019.…
California’s new cybersecurity law sidesteps most medical devices, lawyers say
A new law being implemented by the most populous U.S. state could attract the eyes of FDA as regulators continue to work through guidance on addressing rising cybersecurity threats to medical devices. California’s connected devices security law, which took effect…
Biogen and Sangamo work on Parkinson’s and Alzheimer’s gene therapies
Biogen and Sangamo have begun a collaboration to develop gene regulation therapies for neurological diseases including Parkinson’s and Alzheimer’s in a collaboration worth more than $2.7 billion. Sangamo, which was famously the first company to edit human DNA, only recently…
FDA Approves Esperion’s Nexlizet for Lowering LDL-Cholesterol
The U.S. Food and Drug Administration (FDA) approved Ann Arbor, Michigan-based Esperion’s Nexlizet (bempedoic acid and ezetimibe) for lowering LDL-Cholesterol (LDL-C). The drug is an oral, once-daily, non-statin indicated with diet and maximally tolerated statins for adults with heterozygous familial…
J&J’s Apple Watch-based atrial fibrillation study recruits patients
Apple and Johnson & Johnson have begun enrolling patients in a study that will investigate whether the Apple Watches could be used to detect early signs of atrial fibrillation (AFib). The tech firm has joined with Johnson & Johnson to…
Roche’s Genentech hops on Bicycle’s drug discovery platform for cancer
Roche’s recent spate of billion-dollar plus alliances has continued with a deal with UK biotech Bicycle Therapeutics – worth up to $1.7 billion – in the area of cancer immunotherapy. The agreement is firmly geared towards the back end with…
Gemini Therapeutics and Singapore Eye Research Institute Enter Into Research Collaboration to Explore New Targets for Age-related Macular Degeneration
CAMBRIDGE, Mass.–(BUSINESS WIRE)– Gemini Therapeutics, a clinical stage precision medicine company developing innovative treatments for dry Age-related Macular Degeneration (AMD) and linked ocular disorders, today announced a collaboration with the Singapore Eye Research Institute (SERI) to expand knowledge and identify…
Novartis’ Beovu safety woes could cost billions of dollars, says analyst
The launch of Novartis’ Beovu ophthalmology drug could be compromised after a safety warning from doctors over several cases of sight-threatening inflammation of blood vessels. Beovu (brolucizumab) is a follow-up to the company’s blockbuster Lucentis (ranibizumab) and is approved for…
