BE-101, soon to be known as Optavant, is expected to be commercially available in the third quarter of this year after it receives full licensure from the U.S. Department of Agriculture.
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Deal after deal, Eli Lilly and Co. is using the fruits of its success from developing blockbuster GLP-1 medicines to prepare for its next chapter and build a bridge over a looming patent cliff.
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The laborious process of naming a pharmaceutical takes months and sometimes years of brainstorming, trademark review, legal analysis and regulatory compliance.
The FDA officials predicted the shift would lead to “a surge in drug development.”
The announcement comes on the heels of a deal with the Trump administration to expand access to weight-loss drugs and reduce costs for patients on government-funded insurance and those paying out of pocket.
Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months.
Syndeio Biosciences sees burgeoning potential to treat mental health and cognitive conditions, including Alzheimer’s and depression, with therapies that target the almost countless minuscule brain synapses that give people the ability to think and function.
The Indianapolis-based drugmaker sees orforglipron as a potential global breakthrough treatment for weight loss and other conditions because it comes in pill form, not an injection.
The roster of radiopharmaceuticals players in the Indianapolis area has surged in the past few years to include some of the world’s leading pharmaceutical companies, attracted by the potential for significant growth.
Fauna Bio, based in the San Francisco area, said Thursday it will give Lilly access to its AI platform, called Convergence, to support preclinical drug discovery efforts in obesity.
Firms that normally try to sell drugs as soon as possible are suspending clinical trials and shifting timelines, while patient groups are demanding change.
The new drug, called Zepbound, carries a hefty price of $1,059.87 per month, and insurers and health care plans are balking, questioning its affordability. Many employers and government health programs exclude obesity treatments from their coverage.
The pharmaceutical company has launched 20 drugs in the past decade to treat diseases from arthritis and psoriasis to diabetes and cancer. In recent months, Lilly has overtaken every competitor to become the most valuable drugmaker in the world.
David Ricks, CEO of Indianapolis-based drugmaker Eli Lilly and Co., is turning up the volume on his concerns over a new law that would allow Medicare, for the first time, to negotiate drug prices.
If approved for weight loss, Eli Lilly’s tirzepatide could become the most effective drug to date in an arsenal of medications that are transforming the treatment of obesity, which affects more than 4 in 10 American adults and is linked to dozens of diseases.
Shares in the animal health care company have lost more than two-thirds of their value in the past 18 months, but Elanco says a bevy of new products in its pipeline will prove an era of strong growth is yet to come.
In an amazing resurrection, teplizumab, developed by another company after Lilly trials were a letdown, is one of the hottest new drugs on the market.
The FDA has agreed to speed up review of donanemab, but the Centers for Medicare and Medicaid Services is moving to limit reimbursement for drugs in this class to only patients in clinical trials.
Indianapolis-based Eli Lilly and Co. will make an initial $50 million payment to Entos Pharmaceuticals. Entos also could receive up to $400 million in potential milestone payments, as well as royalties, for successful products.
The companies say they can quickly develop new omicron-targeting antibodies, but those aren’t expected to launch for at least several months.
It’s a big moment for On Target Laboratories, an 11-year-old biotech based in West Lafayette. The FDA approval marks the company’s first novel compound to get across the finish line. The drug is marketed under the brand name Cytalux.
The collaboration could be worth as much as $694 million and potential royalties to Verge Genomics if the two companies hit development milestones.
