Panel says Lilly’s Solpura isn’t ready for approval
Eli Lilly and Co. failed to win an FDA advisory panel’s recommendation to introduce the first pancreatic enzyme that isn’t derived from pig parts.
Eli Lilly and Co. failed to win an FDA advisory panel’s recommendation to introduce the first pancreatic enzyme that isn’t derived from pig parts.
Eli Lilly and Co.’s diabetes partnership with Boehringer Ingelheim GmbH represents a new kind of disease-focused strategy that some consultants think is key to pharma companies’ futures.
The deal Eli Lilly and Co. announced Tuesday morning with Boehringer Ingelheim GmbH sounded a lot like a baseball trade—with five drugs and payments to be named later—but analysts and investors generally liked what they heard.
A complex deal with Boehringer Ingelheim also gives the German company rights to two experimental Lilly insulins.
Outside advisers to the FDA will meet Jan. 12 to review whether the drug should be approved for people with pancreas insufficiency caused by cystic fibrosis, chronic pancreatitis or other conditions.
The Indianapolis-based drugmaker spent $2.1 million in the three months that ended Sept. 30, a 5-percent increase from the same quarter last year and a jump of more than 30 percent from the $1.6 million it spent in this year's second quarter.
Regulators cleared 21 medicines, the fewest since 2007, for sale last year. It was the first time in a decade that Pfizer Inc., the world’s largest drugmaker, as well as Lilly, Merck & Co. and Bristol-Myers Squibb Co. were shut out at the same time, according to agency records.
Marcadia Biotech Inc., a Carmel-based biopharmaceutical company founded by prominent scientists from Eli Lilly and Co. in 2006, has been acquired by Swiss life sciences giant Roche.
Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Wednesday they are asking the Food and Drug Administration to expand approval for their type 2 diabetes drug Byetta, which could bolster sales as the companies try to get approval for a new, longer-lasting version of the drug.
Eli Lilly and Co. started to tip over its massive “patent cliff” this year, yet announced little publicly that will significantly soften its inevitable sales plunge.
Eli Lilly and Co. said the Food and Drug Administration will perform a faster review of florbetapir, an imaging agent that may help diagnose Alzheimer's disease.
Eli Lilly and Co. suspended a late-stage clinical trial of a medicine for skin-cancer patients after 12 patients in the study died.
The trouble-free market approval obtained by Eli Lilly and Co. for a new underarm testosterone treatment brightened the company’s outlook—at least for one of the few optimistic analysts covering the company.
The companies believe the underarm testosterone solution has the potential to realize sales of more than $1 billion a year in the United States.
The Indianapolis-based drugmaker finally won FDA approval for its antidepressant Cymbalta to treat chronic pain and fended off a patent challenge to rising-star cancer drug Alimta, but got a ratings downgrade on its debt.
A U.S. District Court judge on Monday upheld Eli Lilly and Co.’s patent on the cancer drug Alimta, protecting the compound until July 2016. It was a welcome win after a difficult few months for Indianapolis-based Lilly, which is facing a wave of patent expirations in coming years.
If the manufacturer and drugmaker can come to an agreement, Rolls-Royce would lease the space formerly occupied by Eli Lilly and Co. and relocate some of its 2,500 employees to the downtown campus on South Meridian Street. Discussions are expected to last several months.
Pharmaceutical firms led by Eli Lilly are trying to eliminate a government panel aimed at controlling Medicare spending seven months after they supported the health-care overhaul that created it.
Lilly paid $90 million in 2009 to acquire the global rights to the treatment in a bid to beef up its pipeline of medications for autoimmune diseases.
Merck & Co. is betting it can succeed where Pfizer Inc. failed, with a new type of drug to combat heart disease by raising good cholesterol levels. Indianapolis-based Eli Lilly and Co. is testing a similar pill.