Lilly diabetes drug rejected by FDA over manufacturing issue
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.
FDA
Articles
Analysts: Endocyte likely to receive green light on first drug this month
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.
Lilly diabetes drug matches competitors’ effectiveness
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 under FDA review for heart-attack risk
Testosterone drugs, which make up a growing market for pharmaceutical companies such as Eli Lilly, are getting a closer look from U.S. regulators.
Lilly pledges up to $1.8B to Pfizer for access to potential blockbuster
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.
Investors brace for lean years from Lilly
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.
Lilly’s new strategy built around head-to-head drug trials
Lilly has set up not one, not two, but five head-to-head trials of its experimental drug dulaglutide against other leading diabetes therapies. So far, dulaglutide’s record is four wins, no losses.
J&J wins OK for first in new class of diabetes drugs
Johnson & Johnson, the world’s largest seller of health-care products, won approval for the first in a new family of diabetes drugs, giving them the edge against rivals including Eli Lilly and Co. that are developing similar medicines.
Lilly, Boehringer submit diabetes drug to FDA
Eli Lilly and Co. said Monday that it has submitted a new type 2 diabetes treatment it is developing with German drugmaker Boehringer Ingelheim to the Food and Drug Administration.
Endocyte stock sinks due to possible drug-filing delay
Endocyte Inc. saw its shares fall nearly 7 percent Tuesday morning after the drug development firm announced that its application for U.S. approval of a cancer drug could be delayed another 10 months.
Lilly aims to submit five new drugs for approval
With Eli Lilly and Co. set to see patents expire on its best-selling drug at year’s end, it is in the company’s interest to say its pipeline is about to produce new drugs. But the Indianapolis drugmaker may be in a position to submit five new drugs for regulatory approval this year.
Lilly competitor gets backing on diabetes drug
Johnson & Johnson, the world’s largest seller of health-care products, won the backing of U.S. advisers for a diabetes pill the company is seeking to make the first in a new family of drugs for managing blood sugar.
FDA proposes sweeping new food safety rules
The Food and Drug Administration on Friday proposed the most sweeping food safety rules in decades, requiring farmers and food companies to be more vigilant in the wake of deadly outbreaks in peanuts, cantaloupe and leafy greens.
Cook wins approval for new stent
Bloomington-based Cook Medical won approval for the first drug-coated stent for clogged leg arteries in the United States, which accounts for 40 percent of the soon-to-be $3 billion market.
Lilly’s Alzheimer’s drug trials show mixed results
Eli Lilly and Co.’s experimental Alzheimer’s drug failed to meet its primary goals in two separate clinical trials. However, when the results of both trials were combined, the drug appeared to have slowed the decline of cognition in some patients.
FDA’s $6.4B drug review fee plan passes Senate
The U.S. Senate voted to let regulators collect on a $6.4 billion fee agreement struck with Indianapolis-based Eli Lilly and Co., Medtronic Inc. and other companies to fund reviews of new drugs and medical devices through 2017.
Eli Lilly’s Cialis faces faster-acting competition
A Vivus Inc. pill that is supposed to provide erections within 15 minutes, about half the time or less than Eli Lilly and Co.'s Cialis or Pfizer Inc.’s Viagra, has received U.S. regulatory approval.
Lilly receives Europe’s OK for new Byetta use
European regulators have approved an expanded use for the diabetes treatment Byetta, developed by Eli Lilly and Co. and Amylin Pharmaceuticals Inc. The FDA approved the same expanded use last fall.
FDA removes hurdle in Endocyte’s path to drug approval
Endocyte Inc. can start enrolling patients again in a clinical trial of its experimental cancer drug, the company announced Monday, clearing away a hurdle to getting the drug approved in Europe.
Lilly’s ex-partner wins FDA approval for diabetes drug
Amylin Pharmaceuticals Inc. and Alkermes Plc have gained U.S. clearance for Bydureon, a once-weekly diabetes shot. Eli Lilly and Co. co-developed the drug, but ended its partnership with Amylin last year.