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.
The Indianapolis-based pharmaceutical maker gets a much-needed boost with FDA approval for gastric-cancer drug ramucirumab, which quickly could account for $1 billion in annual sales.
Pfizer Inc., Eli Lilly and Co. and Novartis AG have dug an idea out of the pharmaceutical dustbin to create new medicines that are showing blockbuster potential.
Advisers to the Food and Drug Administration voted 13-1 and 14-0 that the drug, Afrezza, should be approved for Type 1 and Type 2 diabetes, respectively. The FDA doesn’t have to follow the panel’s recommendation.
The Lilly-Boehringer drug empagliflozin is projected to reach sales of $295 million for Lilly in 2019, but it won’t be able to sell it until issues are resolved at a German plant.
The European Committee for Medicinal Products for Human Use is scheduled to meet March 17-20, and analysts expect the agency to vote during that meeting to approve vintafolide, Endocyte’s first drug, which treats ovarian cancer.
The Indianapolis drugmaker said dulaglutide performed as well as Victoza, a best-selling drug for Type 2 diabetics made by Denmark-based Novo Nordisk. Analysts think dulaglutide could reach annual sales of $1.5 billion.
Testosterone drugs, which make up a growing market for pharmaceutical companies such as Eli Lilly, are getting a closer look from U.S. regulators.
Eli Lilly and Co. and Pfizer Inc., which are both suffering through some of the largest patent cliffs in the industry, will split any future costs and profits of an osteoarthritis drug that has stalled in clinical testing.
In a new round of predictions this month, Wall Street analysts indicated they expect Eli Lilly and Co.’s revenue to fall next year and to remain below 2013 levels until 2020.
