The expert panel for the Food and Drug Administration voted 19-1 that the drug’s modest benefits don’t outweigh its considerable risks, even with proposed measures to restrict who gets the medicine.
Eli Lilly and Co. on Saturday morning presented highly anticipated details from a mid-stage study showing that its experimental drug slowed Alzheimer’s disease progression over about 18 months.
Eli Lilly and Co. told Reuters news agency that it is working closely with the FDA to address concerns about the factory in Branchburg, New Jersey, which makes Trulicity.
The Indianapolis-based drugmaker said it will begin shipping the additional doses immediately to the federal government, which controls distribution of the drugs.
The bill pitted the two largest companies headquartered in Indianapolis—drugmaker Eli Lilly and Co. and health insurer Anthem Inc.—on opposite sides of the issue.
If you follow the daily drumbeat of news emanating out of Lilly Corporate Center, you might not grasp how phenomenally well the company is poised to perform in the coming years.
Josh Smiley, Lilly’s CFO since 2018, resigned from the company after the drugmaker said he had engaged in a improper personal relationship with an employee.
The combo treatment is the second COVID-19 antibody therapy from the Indianapolis-based drugmaker to gain an emergency authorization from the FDA.
Joshua Smiley, who was Lilly’s second-highest-paid employee, was named CFO in January 2018. Lilly said Smiley also engaged in “inappropriate personal communications” with other employees.
Lilly has spent three decades and more than $3 billion trying to find a way to treat Alzheimer’s disease. Its latest drug, donanemab, finally shows real promise.
The antibody treatment bamlanivimab was Lilly’s second-highest selling product in the final quarter of 2020, trailing only the popular diabetes drug Trulicity.
GlaxoSmithKline and partner Vir Biotechnology Inc. have teamed up with Indianapolis-based Eli Lilly and Co. to test a combination of their COVID-19 antibody treatments to see whether they can better combat the virus and its variants together.
Merus N.V. specializes is so-called CD3 engaging T-cell therapies, a growing area of cancer research, based on immunotherapy, or using the immune system’s T cells to find and shrink tumors
The Indianapolis-based drugmaker said people from minority communities are frequently “unseen” by the U.S. health care system.
Several other Indiana companies also say they are suspending contributions to all candidates or are taking a close look at the matter.
So far this month, drugmakers have hiked prices on 636 drugs, according to research by GoodRx, which tracks prescription drug prices and offer a mobile app to help consumers find the lowest prices on hundreds of drugs.
The experimental drug, donanemab, could be a huge breakthrough for Lilly, which has spent billions of dollars over 30 years researching treatments for Alzheimer’s disease, only to see them fall short in clinical trials.
For a highly touted drug meant to keep throngs of people out of hospitals during a pandemic, Eli Lilly and Co.’s wonder treatment bamlanivimab sure has been slow to catch on.
Red tape, staff shortages, testing delays and strong skepticism are keeping many patients and doctors from the drugs made by Eli Lilly and Co. and Regeneron Pharmaceuticals.
Lilly stock climbed Tuesday after the drugmaker laid out a better-than-expected revenue forecast and plans to buy a young company developing a potential Parkinson’s disease treatment.
