FDA chief Scott Gottlieb steps down, leaving pet projects behind, (by Eric Sagonowsky on FiercePharma.com, 5 March 2019) is the big shake-up that will iimpact our T1 community.
Gottlieb was biopharma-friendly—to the point where the Nasdaq biotech index plummeted at the news of his departure—but he also made a few moves companies didn’t particularly like. Speeding up generics, for instance, and decrying the games branded drugmakers play to keep copycats from hitting the market. he streamlined the drug approval process, and it was under him that the FDA waved through a record-breaking number of new drugs in 2018, and has shown support—and in some controversial cases, tolerance—for drug innovation. His sudden departure will likely leave many agency efforts to lower costs up in the air.
- FDA chief Scott Gottlieb steps down, leaving pet projects behind
- Gottlieb’s quick goodbye triggers investor panic, biopharma bewilderment
Senseonics Announces Appointment of Francine R. Kaufman, M.D. as Chief Medical Officer was announced on the Senseonics website, 6 March 2019.
Dr. Kaufman’s career spans almost 40 years in diabetes care. She is a dedicated pediatric endocrinologist and has served as director of the Comprehensive Childhood Diabetes Center, and head of the Center for Endocrinology, Diabetes and Metabolism at Children’s Hospital Los Angeles. Dr. Kaufman is also a Distinguished Professor Emerita of Pediatrics and Communications at the Keck School of Medicine and the Annenberg School of Communications of the University of Southern California. She was formerly the president of the American Diabetes Association, chair of the National Diabetes Education Program and elected to the National Academy of Medicine. She is the author of over 250 scientific manuscripts and numerous books, including Diabesity: The Obesity-Diabetes Epidemic That Threatens America and the ADA’s Insulin Pumps and Continuous Glucose Monitoring: A User’s Guide to Effective Diabetes Management. Dr. Kaufman is an active philanthropist working with numerous organizations and charities around the world aimed at improving the lives of people with diabetes. She was also an advisor to the Governor on the California Initiative on Health, Fitness and Obesity. Most recently Dr. Kaufman served as Chief Medical Officer and Vice President of Global Clinical, Regulatory and Medical Affairs at Medtronic Diabetes.
Yup, a POWERHOUSE!!! “We are pleased to have Fran join the executive leadership team at Senseonics. As Chief Medical Officer, she will be instrumental in helping drive forward our innovation platform and the clinical value proposition of the Eversense system,” said Tim Goodnow, President and CEO of Senseonics.
Eli Lilly’s Hazy Memory was reported by Adam Wren in IndianapolisMonthly.com, March 2019. This is just following my blog post last week about CBD and cannabis.
According to Fred Pfenninger, (a 69-year-old former attorney turned Eli Lilly and Company diversification analyst, Marion County Republican precinct committeeman works in an office where the walls are adorned with diplomas from Indiana University, University of Michigan Law School, and Harvard Business School). Lilly was once “a worldwide leader in the distribution of cannabis-based pharmaceuticals.” At a farm in Greenfield, it grew 156 acres of marijuana during the early decades of the 20th century.
The original Mission-style building still stands at what was once Lilly’s marijuana farm in Greenfield.
In 1850, the United States Pharmacopeia, the nation’s official drug-reference manual, listed cannabis as a legitimate treatment for a wide range of ailments. The United States Dispensatory, another reference book, advised doctors that it could serve as a medicine to “cause sleep, to allay spasm, to compose nervous disquietude, and to relieve pain.” It was a useful treatment for “gout, rheumatism, tetanus, hydrophobia, epidemic cholera, convulsions, chorea, hysteria, mental depression, delirium, tremens, insanity and uterine hemorrhage.” For decades, doctors prescribed it liberally.
For the most part, patients were using a strain of cannabis shipped from India known as cannabis indica. In the late 1800s, pharmaceutical companies such as Parke-Davis—a forerunner of Pfizer—and Squib imported the plant, according to Reefer Madness, Larry Sloman’s history of marijuana. And as Pfenninger says, Lilly did, too, selling 23 cannabis-infused medicines.
But scan the major histories of Lilly—James H. Madison’s Eli Lilly: A Life, 1885–1977 and E.J. Kahn’s All in a Century: The First 100 Years of Eli Lilly and Company—and you won’t find a single mention of the business’s exploits in selling marijuana-based medicine. “I don’t recall that at all,” admits Madison, one of the state’s foremost historians.
J. Scott MacGregor, Lilly’s global communications director, declined to answer specific questions relating to this story. Although Lilly has vast archives, only scant evidence of those days remains outside the company’s headquarters. Antiques collectors have tinctures with the red-and-white Lilly label featuring cannabis sativa. But newspaper stories about those medicines and other accounts of them are scarce.
Read more: Eli Lilly’s Hazy Memory
How helpful gut microbes send signals that they are friends, not foes was reported by Jeremy Rehn on ScienceNews.org, 7 March 2019. The finding in mice may help explain why a body’s immune system doesn’t kill beneficial bugs
Observations in mice show that certain filamentous microbes use a hooklike appendage to send messages that researchers believe are aimed at preventing immune cells from attacking the microbes.
The finding, reported in the March 8 Science, could help explain how an immune system distinguishes friendly gut bacteria from deadly pathogens, says microbiologist Primrose Freestone of the University of Leicester in England, who was not involved in the research.
Because the gut provides an easy gateway for microbes to infect a person or other animal, the intestine is replete with immune cells ready to attack. Researchers have closely examined how immune cells such as T cells recognize and attack pathogens like E. coli. But it’s unclear why these same immune cells don’t kill the trillions of gut microbes that help with digestion and keep people healthy.
Immunologist Ivaylo Ivanov at Columbia University and his colleagues examined segmented filamentous bacteria, a group of gut microbes found in the intestines of many animals including mice, fish and humans. These symbiotic bacteria have a hooklike appendage called a holdfast that attaches them to cells on the gut’s wall.
Microscopic 3-D images of holdfasts from more than 200 individual bacteria cells revealed small bubbles, or vesicles, emerging from the hook’s sides and tips and budding off within the intestinal wall.
“This was something nobody had noticed before,” though researchers have studied segmented bacteria since the 1960s, Ivanov says. Chemical tests revealed that the vesicles, like delivery packages, contained the bacteria’s antigens — proteins that immune cells use to recognize a foreign body. Usually, antigens stimulate immune cells to attack and kill an invader. But in this case, although T cells were activated, they didn’t go after the bacteria.
“We’re maybe looking at some new biology,” perhaps a new way of communicating, Ivanov says. “I was not expecting to identify a new type of interaction,”