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August 29, 2019 FDA issued draft guidance at the end of April on voluntary recalls’ initiation process under 21 CFR part 7 subpart C. “We know that in order for a recall to be effective and timely,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
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