Congress passes bill to fund FDA drug, medical device reviews
Drug and medical device makers would pay higher user fees under legislation the U.S. Senate approved and sent to the president on Thursday.
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Lilly, Pfizer get boost for non-opioid pain drug
The companies say the drug, now in late-stage clinical trials, could be more effective for pain treatment than opioids—a dangerous category of pain killers that includes hydrocodone, morphine and fentanyl—without the abuse potential of such medications.
Pharmakon owner, compliance director face criminal charges
The owner and the director of compliance for Noblesville-based Pharmakon Pharmaceuticals Inc. have been charged with multiple criminal counts related to the sale of over-potent compounded painkillers that sickened at least three infants.
Lilly migraine drug provides relief in late-stage trials
Lilly is in a race with several pharmaceutical firms to develop migraine treatments using an approach known as anti-CGRP and that could create a multibillion-dollar market.
Wall Street punishes Lilly for latest drug setback; analysts grasp for answers
News that federal regulators rejected Lilly’s drug for arthritis sent the stock tumbling more than 5 percent Monday, and sent surprised analysts searching for answers.
Lilly’s rheumatoid arthritis pill rejected by regulators
The drug, which has the proposed brand name Olumiant and is approved for use in Europe, was expected to be a big seller.
Lawmakers hear bill to establish ‘hemp oil registry’ for seizure patients
One of the bill’s author said it is designed to help parents who are “up against a wall,” and he stressed that it should not be confused as a first step to medical marijuana legalization in the state.
At Eli Lilly, tears, heartbreak and renewed determination
Eli Lilly and Co. employees knew the Alzheimer's treatment solanezumab was not a sure bet. But that didn’t make the pain any less acute after the company announced the drug had failed to demonstrate effectiveness during a 2,100-patient Phase 3 clinical trial.
Lilly cancer drug lands accelerated FDA approval
Lartruvo is the first front-line therapy approved by the FDA to treat soft tissue sarcomas since doxorubicin more than 40 years ago.
Lilly drug for Alzheimer’s gets fast-tracked by FDA
Named AZD3293, the drug belongs to a novel class of drugs that block production of amyloid, a protein that causes plaque to build up in the brain of Alzheimer’s patients.
Lilly stock rises after FDA panel backs new Jardiance label
A hot-selling drug for diabetes sold by Eli Lilly and Co. and a co-partner just got another potential boost, as a government panel narrowly recommended that the companies should be allowed to claim that the drug cuts the risk of cardiovascular death.
Lilly angles for arthritis blockbuster
Within six months, Eli Lilly and Co. could know whether the Food and Drug Administration has approved its latest drug, baricitinib, a once-a-day tablet for treating rheumatoid arthritis.
Lilly wins FDA approval for plaque psoriasis drug
For Eli Lilly and Co., the approval rewards a decade-long effort to re-enter the biotech and autoimmune spaces that it helped pioneer in the 1980s but then abandoned in the 1990s.
FDA OKs once-a-day insulin that could be blockbuster for Lilly
The FDA said Wednesday it approved Basaglar based on data showing it is safe and effective and works similarly to Lantus, the world’s top-selling insulin.
FDA approves female sex pill, but with safety restrictions
The Food and Drug Administration on Tuesday approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.
Lilly, partner sue Lupin over generic testosterone
Indianapolis-based Eli Lilly and Co. and Acrux DDS Pty Ltd. have filed a lawsuit against Lupin Pharmaceuticals Inc. for alleged infringement of patents that cover the testosterone treatment Axiron.
Warnings ordered on testosterone drugs like Lilly’s Axiron
Makers of testosterone drugs must change the products’ labels to clarify that they are approved for only certain disorders, not to help men deal with aging, U.S. regulators said.
Lilly to delay U.S., EU approval of basal insulin
Although the experimental diabetes drug is in final-stage testing and showing promising results, Lilly wants to better understand its effect on liver fat.
FDA approves Eli Lilly’s injectable diabetes drug
The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes, which affects more than 26 million Americans.
Testosterone drugs need study on heart risks, FDA panel says
Drugmakers, including Eli Lilly and Co., should conduct new trials to assess the heart risks of testosterone therapies used by millions of men last year, advisers to U.S. regulators said.