August 29, 2019 FDA issued draft guidance at the end of April on voluntary recalls’ initiation process under 21 CFR part 7 subpart C. “We know that in order for a recall to be effective and timely,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
August 15, 2019 Going forward, though, one thing will change, several lawmakers told the pharma and PBM executives. The “status quo is not going to continue,” Rep. Joe Kennedy said. “It can’t.” That remains to be seen, but at a hearing, members of the House Committee on Energy and Commerce highlighted some of the reasons … Read more
August 13, 2019 The scheme of illegal kickbacks and bribes could amount to one of the largest healthcare fraud cases ever seen by the FBI and the Department of Health and Human Services’ (DHHS) Inspector General’s Office, according to the agencies. Arrests were made Tuesday, April 9, 2019, and two (2) dozen people have been … Read more
August 08, 2019 Now, using CRISPR-Cas9 knockout screens and RNA sequencing, a Stanford University team of scientists has identified CD22 — a B-cell receptor that keeps immune responses in check — as a negative controller of microglial phagocytosis. Tuning down CD22 appears to improve cognitive function in aged mice. The researchers reported their findings in … Read more
August 06, 2019 To start, the retail and computing giant has paired up with six (6) companies to develop programs that can harbor protected prescription information, book doctor appointments, track blood glucose levels and find the nearest urgent care center. That includes a program from the digital health company Livongo, a member of the 2017 … Read more
August 02, 2019 Alec Burkaloff, who pleaded guilty in a Boston courthouse in November 2018 on federal racketeering charges, agreed in April to forfeit $9.5 million and admit his role in a plan to induce physicians to write scripts for the company’s under-the-tongue fentanyl spray as part of a paid speaker program he personally managed. … Read more