Welcome to Trends-in-Medicine, offering independent, cutting-edge articles and information on drugs and devices in development. Our subscribers have access to news and analysis on the latest data, regulatory issues, and trends of interest to the healthcare community.

Monkeypox: The Unanswered Questions

The monkeypox outbreak is spreading rapidly worldwide, but there are a lot of unanswered questions. How is the virus transmitted? Can you get it from blood? Is the blood supply safe? Why isn’t there more effort to boost the vaccine supply? While monkeypox is not as fatal as HIV/AIDS or Covid-19, will it become the next pandemic? Here is a discussion of these questions and others that need attention if the mistakes of HIV/AIDS and the Covid-19 pandemic are to be avoided.

American Diabetes Association - Incretins

There was a lot of news at the ADA meeting on both drugs and devices, but one area that really stood out was the new incretins – approved and on the horizon. Some of these offer three advantages: lower HbA1c, weight loss, and easier dosing. There were also some very early but promising data on islet cell therapy for Type 1 diabetes.

White House Monkeypox Update

Biden administration officials, in a zoom conference with reporters, discussed the monkeypox outbreak and the actions they are taking to combat it, including increasing orders for vaccines and tests. However, they also left a lot of questions unanswered.

Virus Update

What virus should you be worried about today – coronavirus (Covid-19), monkeypox, adenovirus (hepatitis), bird flu, or the latest, Powassan virus? And there are others. For more than two years, coronavirus dominated the news, but recently several old – but serious – viruses have popped up in the news. Here is an update on each of these, with the key takeaways and things to know.

ASCO Preview

The American Society of Clinical Oncology (ASCO) meeting will take place June 3-7, 2022. Here is a report on what ASCO officials previewed for the meeting. They focused on equity, not the expected clinical trials.

ASGCT News

It was clear at the American Society of Gene and Cell Therapy (ASGCT) meeting that cell and gene therapies are alive and well, with many trials in progress. Late-breaking (but early-stage) data were uniformly positive. And officials from the FDA and the EMA explained the regulatory changes affecting the field that they expect as the pandemic winds down. In the EU there will be an end to rolling review, more focus on GMO and durability, and more flexibility but no conditional approvals. The FDA may consider pilots, likely will continue accelerated approvals and surrogate endpoints, and wants to improve review consistency, but sees reimbursement remaining an issue.