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.
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.
Testosterone supplements used last year by about 2.3 million men are spurring debates over how necessary and safe they may be, even as U.S. regulators consider approving a new product.
The two companies will work together to develop AZD3293, which belongs to a novel class of drugs called BACE inhibitors that block production of amyloid, a protein that causes plaque to build up in the brain of Alzheimer’s patients.
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.
Eli Lilly and Co. executives on Friday repeated their plea to local businesses to support early childhood education, highlighting the work force development and crime-reduction benefits associated with the effort.
Eli Lilly and Co. said Friday its potential colorectal cancer drug Cyramza helped patients on chemotherapy with advanced cases of the disease survive longer than patients on chemotherapy alone.
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.
Takeda Pharmaceutical Co. and Eli Lilly and Co. lost a bid to have a judge throw out a combined $9 billion punitive-damage award over claims the drugmakers hid the cancer risks of their Actos diabetes medicine.
This is far from the first time that heirs and beneficiaries of the Lilly family fortune have tangled over how it was managed.
The drug company said Thursday its drug ixekizumab cleared away skin inflammation in six times as many patients as the blockbuster drug Enbrel. Lilly is in a race to bring the first in a new-class of psoriasis treatments to market.
Final approval could be delayed until mid-2016 due to a claim of patent infringement by drugmaker Sanofi.
The rising threat from drug-resistant germs and increasing calls from global health groups for more potent antibiotics is placing a premium on companies such as Cubist. The $4.8 billion drug developer is preparing to introduce four new medicines by 2020.
Lilly expects to soon announce late-stage clinical trial results for two biotech drugs designed to slow the inflammation caused by autoimmune diseases. By the end of the year, it will announce results for a third.
The plant closure will affect 23 plant employees, all of whom will be offered comparable positions at a Lilly plant near Clinton that employs about 500 workers.
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.
Results of a Roche clinical trial mirror those produced by an experimental Lilly drug two years ago. Lilly executives say that validates their approach in the multi-billion-dollar race to market the first drug to reverse Alzheimer’s.
The areas around each of Indiana’s research university campuses—Bloomington, Indianapolis, Lafayette and South Bend—all boast outsize concentration of life sciences workers. Yet the state still lags on research, development and investment funding.
Lantus, which garnered $7.8 billion in sales for Paris-based Sanofi in 2013, loses patent protection in Europe in May next year.
A new research consortium spearheaded by the Indiana University School of Medicine and Eli Lilly and Co. could bring in $25 million to $50 million over five years to create a new approach for developing drugs that provide more precise treatment for small groups of patients.
Dr. Ora Pescovitz is returning to Indianapolis after spending the past five years as CEO of the University of Michigan Health System.