Hello, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that familiar routine of meetings, deadlines, and whatnot has returned. But you knew this would happen, yes? So to cope, we are quaffing cups of stimulation. Feel free to join us. The neurons can also use a little stimulation. Meanwhile, here are some tidbits to help you along. Have a great day and do keep in touch …
An FDA panel will vote Tuesday on whether the label for Jardiance — a diabetes drug from Eli Lilly and Boehringer Ingelheim — should be updated to say it can lower the risk of major cardiovascular events, Reuters says. A study found the drug cut the risk of death from heart attacks and strokes, becoming the first glucose-lowering medicine to show protective results in a large clinical trial.
Six former FDA commissioners believe the agency should be independent, STAT tells us. The FDA is currently part of the US Department of Health and Human Services, but giving it Cabinet-level status or finding another way to authorize more autonomy would be better for public health, the former commissioners said at a weekend meeting, which was also the first time they all supported such a move publicly.
Arizona has run out of execution drugs, including the midazolam sedative implicated in botched lethal injections, according to Reuters, citing a filing filed on Friday in a court case challenging the state’s execution methods. The midazolam, which is made by Akorn Pharmaceuticals, expired on May 31 and the state corrections department it has not been able to replace it. Akorn took steps last year to prevent its drug from being used for executions.
Dr. Reddy’s Laboratories ended a strategic alliance with GlaxoSmithKline for emerging markets outside India and plans to pursue these markets on its own, LiveMint tells us. The revenue-sharing deal was struck in 2009 and was created to develop and market select generic drugs in markets such as Latin America, Africa, the Middle East, and Asia-Pacific, excluding India.
Five drug wholesalers agreed to a $4.2 million settlement in a lawsuit alleging they shipped an excessive number of prescription opioids to West Virginia, the Associated Press tells us. Meanwhile, the West Virginia Board of Pharmacy is developing a system to rank doctors by specialty based on the number of prescriptions they write for painkillers, the Charleston Gazette-Mail writes.
The US Senate might vote next month on its companion to the House’s 21st Century Cures bill, despite procedural obstacles, Bloomberg News reports.
Sanofi and Boehringer Ingelheim agreed on a $25.1 billion asset swap that will bolster the French drug maker’s business selling over-the-counter drugs while exiting animal health, Bloomberg News says.
In June of 2015, it was discovered that I had type 2 diabetes. By the end of the month, I was given a prescription for Metformin. I stated the ADA diet and followed it completely for several weeks but was unable to get my blood sugar below 140. With no results to how for my hard work, I panicked and called my doctor. His response? Deal with it. I began to feel that something wasn’t right and do my own research. Then I found Rachel’s blog (google ” HOW I FREED MYSELF FROM THE DIABETES ” ) . I read it from cover to cover and I started the diet and by the next morning, my blood sugar was 100. Since then, I have a fasting reading between the mid 70s and 80s. My doctor was so surprised at the results that, the next week, he took me off the Metformin. I lost 30 pounds in the first month and lost more than 6 inches off my waist and I’m able to work out twice a day while still having lots of energy. The truth i.e can get off the drugs and help myself by trying natural methods
Congrats Elaine. Type 2 diabetic too, started on metformin 1000mg/. The resulting diarrhea was so explosive I had to hold on to the toilet to avoid lift off. Scaled back to 500 along with liraglutide but have to lose weight to achieve sub 100 FBG.
The way to take the FDA private is not to become a profitable enterprise. The perfect model already exists in the form of National Trusts. These are independent private non profit corporations set up around the world for many purposes and enjoy good reputations. They have boards of directors and trustees, which is where decisions begin and end. Every pharmaceutical company would be required to donate annually to the “United States National Trust for Food and Drug Safety”, which in turn would contract the reviews to private consultants, which FDA does anyway. The donations would be based on annual sales, real or projected for startups, and would replace user fees. All decisions would be binding and could only be overturned by POTUS.
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