September 19, 2019 The company describes the assay as the first and only rapid test cleared by the FDA for use in diagnosing diabetes or for monitoring a person’s risk for developing the condition in the future. The Afinion HbA1c Dx test is now available for use on Abbott’s Afinion 2 and AS100 analyzers. “In … Read more
September 17, 2019 Thumbs up, mostly, according to a survey by WeGo Health. The company checked in with 550 influential patients and found the majority value drug price transparency and the new rule. For instance, while seven (7) in 10 of the patients, who are opinion leaders in their fields, said they do not think pharma is … Read more
September 12, 2019 The team found that blocking CA19-9 could serve as a therapeutic strategy to prevent the progression from chronic pancreatitis to pancreatic cancer. The findings were just published in the journal Science, but they have already been translated into an antibody drug acquired by BioNTech called MVT-5873. The CA19-9 antibody is already in … Read more
September 10, 2019 Awareness of patient preferences can also be applied in the design of the device itself, of course, and the FDA hopes to identify the key areas where deeper knowledge would have the largest impacts — such as in how patients may value the benefits and risks of a certain technology or treatment … Read more
September 05, 2019 In 2018, the FDA greenlit 106 new devices — including premarket approvals and panel-track supplements; de novo and breakthrough 510(k) clearances; and humanitarian device exemptions — beating out 2017’s 40-year record of 98 devices. Some of these include the world’s smallest mechanical heart valve, developed by Abbott and St. Jude Medical for … Read more
September 03, 2019 In recent years, the U.K. has tried to establish itself at the forefront of global efforts to address the problem of antimicrobial resistance (AMR) through activities including an earlier five-year strategy and the commissioning of an independent review. Now, the U.K. has set out its hopes for the next five (5) and … Read more
August 29, 2019 FDA issued draft guidance at the end of April on voluntary recalls’ initiation process under 21 CFR part 7 subpart C. “We know that in order for a recall to be effective and timely, it’s crucial that companies be prepared in advance to take all necessary steps for when a recall is … Read more
August 27, 2019 The prescription-only treatment — NeuroSigma’s Monarch external trigeminal nerve stimulation system — is designed for children who are currently not taking any medications. About the size of a cellphone, the device delivers a mild electrical pulse to a wired patch placed on the patient’s forehead while sleeping. By stimulating the branches of … Read more
August 22, 2019 Gottlieb, in fact, denied to reporters at the start of the year that he was leaving; however, a few short months later he announced he was doing exactly that (citing commuting times), and then preceded to have the world’s longest goodbye tour. Fitting, I suppose, for a rock’n’roll FDA Commissioner. Many in … Read more
August 20, 2019 Sanofi committed the donation via Twitter in April. In a statement, CEO Olivier Brandicourt said the cathedral had “survived for centuries” and Sanofi would help make sure that does not change. The drugmaker “can be proud that our company is participating in its restoration for future generations,” he said. Sanofi joins many … Read more