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.
CEO Doug Oberhelman said Tuesday that government overhauls and an aggressive economic development policy have made the state among the most attractive for investment.
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.
Cited for lax enforcement in the past, Indiana’s workplace safety agency wants to recruit more companies into an honor-system program that takes them off the list for surprise inspections.
Service event is as good for you and your customers as for the causes you will help.
European regulators have approved a long-lasting insulin from Eli Lilly and Co. and German drugmaker Boehringer Ingelheim that is the subject of patent-infringement litigation with French rival Sanofi.
Gov. Mike Pence unveiled a new government management program Tuesday, one that he promised will improve efficiency and save the state money in the long run but that comes with a hefty price tag.
Companion Diagnostics Inc., a biotech company that relocated to Indiana from Connecticut in 2010, has entered bankruptcy reorganization while it tries to develop a therapy for inflammation.
Eli Lilly and Co. plans to seek regulatory approval early next year for a new once-a-day insulin after the diabetes treatment fared better than the blockbuster drug Lantus in two late-stage clinical studies. According to the Associated Press, Lilly’s drug peglispro produced statistically significant lower blood sugar levels in Type 1 diabetes patients when compared to people who took Lantus, which garnered $7.8 billion in sales last year for France-based Sanofi SA. Peglispro is a basal or background insulin that patients with Type 1 or Type 2 diabetes can take along with shorter-acting mealtime insulin to help keep blood sugar levels stable.
St. Vincent Health wants to build a $14 million sports performance facility for serious athletes at Indy Cycloplex, a city park that includes the Major Taylor Velodrome cycling track. St. Vincent’s proposal is one idea being discussed with Marian University, which has a contract to manage the park for the city, and four amateur sports groups: Indiana Sports Corp, Play Ball Indiana, USA Football and USA Track & Field. St. Vincent’s idea, if accepted, could become reality as early as 2017. While no firm plans are in place, the groups are likely to discuss the possibility of relocating their offices or some of their operations to the site to create an “amateur sports community,” officials said. The four sports groups are all based in Indianapolis, but are spread around the city. Facilities for research, training, sports safety and performance are among the possible development options on the table in the hope they could attract other sports-governing bodies to Indianapolis. Another possibility for the site is a youth sports park.
Just three months before the parent company of AIT Laboratories was sold in 2009 to its employees for $90 million, it was appraised for less than one-fifth as much, according to a lawsuit filed Aug. 29 by the U.S. Department of Labor. That sudden swing in value is why the federal government has sued AIT founder Michael Evans and the bank he hired to help sell AIT, alleging they breached their fiduciary duties. The suit, filed in federal court in Indianapolis, asks the court to force Evans and Louisville-based PBI Bank to give back any gains they made from the sale. Evans, 70, owned nearly 88 percent of AIT when it was sold to an employee stock ownership plan, or ESOP, according to the lawsuit. Evans did not cash out that entire stake immediately when the sale was made, but instead was to be paid over time as AIT employees made contributions to the ESOP, which functions as their company retirement plan. The lawsuit claims Evans has been paid $16.3 million. It's not clear from the suit how much more he might be in line to collect. The complaint notes that in 2013, a period when AIT was under severe financial pressure, a recapitalization resulted in Evans, who had helped finance the buyout, receiving a 90-percent stake in AIT. Meanwhile, the ESOP's stake shrank from 100 percent to 10 percent.
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.
The home-improvement retail giant plans to hire 1,000 workers for the center at Intech Park on the northwest side. The jobs would pay an average hourly wage of about $16.
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.
United Way spent nine months putting together The New U—a strategic shift intended to speed change by investing in programs that make a measurable difference in the areas of education, income, health and basic needs.
Ohio-based Cardinal Health Inc. wants to open a $14.4 million drug-production facility that would employ 85 workers by 2017. A Cardinal subsidiary, Cardinal Health 414 LLC, produces a cancer treatment locally at a compounding center on Georgetown Road. The Indianapolis Department of Metropolitan Development said Cardinal wants to expand production of the medication by opening a second facility in an existing 64,000-square-foot warehouse at 4343 W. 62nd St. If the project goes forward locally, the company said it would spend $11.5 million to make the building suitable for pharmaceutical production and another $2.9 million in manufacturing and research equipment for the facility. Cardinal wants a tax abatement valued at $690,297 over 10 years. During that time, the company still would pay $648,169 in property taxes.
Consolidated Insurance Services Inc. has merged with Shepherd Insurance, creating an insurance agency with eight Indiana offices, 145 agents and more than 160 employees. Consolidated will now operate as Consolidated Shepherd Insurance, while Shepherd will maintain its name. Shepherd is based in Carmel and has offices in Noblesville, Greenfield, Columbus, Evansville and Seymour. The agency, which in recent years has bulked up its presence in health insurance, was founded in 1977 by Dave Shepherd, who won Indiana's Mr. Basketball award in 1970 while at Carmel High School. Consolidated, founded in 1932, is led by Rex Early, the former Republican state chairman and gubernatorial candidate.
Eli Lilly and Co. and a partner drugmaker won tentative regulatory approval for a once-a-day insulin that will compete with Lantus, the blockbuster insulin made by France-based Sanofi SA. Called Basaglar, the drug is approved for adults with type 2 diabetes and in combination with mealtime insulin for adults and children with type 1 diabetes. Lilly co-developed the drug with Germany-based Boehringer Ingelheim GmbH. The approval is tentative because of a claim of patent infringement filed by Sanofi. The U.S. Food and Drug Administration cannot give final approval of Basaglar until mid-2016, unless courts find in favor of Lilly earlier.
Eli Lilly and Co. will submit its experimental psoriasis drug for regulatory approval after the medicine helped six times as many patients participating in clinical trials completely clear up their skin irritations as an existing treatment. Lilly’s drug, ixekizumab, is in a race with two others to be first in a new class of psoriasis treatments to reach the market. Lilly expects to submit the drug to regulators—most likely in the United States, Europe and Japan—in the first half of 2015. The commercial prospects for ixekizumab are uncertain. Before Thursday’s announcements, Wall Street analysts expected the drug to fall short of $1 billion in annual sales by 2020. Switzerland-based Novartis AG already has submitted its drug for psoriasis to the FDA, and expects a decision as early as year’s end. California-based Amgen Inc. has partnered with United Kingdom-based Astra Zeneca plc on a new drug for psoriasis, but they have yet to complete late-stage testing.
This is far from the first time that heirs and beneficiaries of the Lilly family fortune have tangled over how it was managed.