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.
The drug, which has the proposed brand name Olumiant and is approved for use in Europe, was expected to be a big seller.
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.
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.
Lartruvo is the first front-line therapy approved by the FDA to treat soft tissue sarcomas since doxorubicin more than 40 years ago.
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.
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.
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.
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.
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.
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.
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.
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.
Although the experimental diabetes drug is in final-stage testing and showing promising results, Lilly wants to better understand its effect on liver fat.
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.
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.
Lilly is finally putting meat on the bones of its predictions about its experimental diabetes and cancer drugs. That gives investors the certainty they crave that Lilly’s future revenue won’t remain in its 2014 doldrums.
The Indianapolis-based drugmaker said Thursday that peglispro produced statistically significant lower blood sugar levels in patients when compared to people who took the Sanofi insulin Lantus in two late-stage studies of people with type 1 diabetes.
Final approval could be delayed until mid-2016 due to a claim of patent infringement by drugmaker Sanofi.
Founders of Chondrial Therapeutics believe that if further testing validates their treatment for Friedreich’s ataxia, it could be a blockbuster with annual sales topping $1 billion.
The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes who also are trying to control their condition with diet and exercise.