Competitor beats Lilly to market with migraine drug approval
The competition for the multi-billion dollar migraine market is set to heat up with the FDA expected to decide on Lilly’s migraine therapy next month.
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In setback for Lilly, FDA limits dosage, slaps warning on new arthritis drug
The Indianapolis-based drugmaker has been working for years to develop the much-anticipated drug, which some analysts had said might ring up $2 billion a year in sales.
Gene therapies that could transform diseases get easier FDA path
New therapies that could cure diseases caused by defective genes will get quicker approval from U.S. regulators, part of an effort by the Food and Drug Administration to keep pace with one of biotechnology’s fastest-growing fields.
Congress gives dying patients easier access to unproven drugs
President Donald Trump’s interest in the bill stems from a push by Vice President Mike Pence, who championed the initiative when he was governor of Indiana.
Indiana-based Rose Acre Farms recalls 200M eggs over salmonella concerns
A notice posted on the Food & Drug Administration website says the eggs shipped to restaurants and grocery stores in nine states may be tainted with salmonella.
Lilly signs licensing deal with biotech startup for diabetes drug
Under the agreement, Lilly will pay Sigilon Therapeutics up to $410 million if the technology hits certain milestones.
FDA opens new path for Alzheimer’s therapy as failures mount
The Food and Drug Administration proposal will create new opportunities for drugmakers after repeated failures from companies including Indianapolis-based Eli Lilly and Co.
FDA aims to expand early-approval program for promising drugs
The Food and Drug Administration wants to help patients get faster access to promising cancer treatments, FDA Commissioner Scott Gottlieb told House lawmakers Thursday.
FDA approving drugs at accelerated pace
Thirty-four new drugs—treating everything from cancer to rare genetic diseases—have been approved so far this year. That’s on pace to nearly double last year’s approvals.
FDA acts to encourage generic competition for complex drugs
The U.S. Food and Drug Administration is opening a new front in its efforts to reduce high drug prices by encouraging development of generic versions of hard-to-make medicines.
FDA approves Lilly drug for common advanced breast cancer
U.S. regulators have approved a new medicine for treating a common type of breast cancer after it has spread to other parts of the body.
FDA’s consumer protection warnings falling under Trump
From January to July, the agency sent 265 warning letters to companies, notifying them of what it alleged to be serious violations of federal rules. That’s the lowest tally for the first seven months of any year since 2008.
Lilly competitor reaches $46.5M settlement with U.S. over safety info
Danish drugmaker Novo Nordisk says it has reached a settlement over allegations that it hadn’t properly communicated safety information when marketing a medicine to treat type 2 diabetes.
Lilly shares rise on surprising news from FDA on arthritis drug
The Indianapolis drugmaker said it will not be required to conduct another expensive, time-consuming clinical trial for the potential blockbuster.
Congress passes bill to fund FDA drug, medical device reviews
Drug and medical device makers would pay higher user fees under legislation the U.S. Senate approved and sent to the president on Thursday.
Lilly, Pfizer get boost for non-opioid pain drug
The companies say the drug, now in late-stage clinical trials, could be more effective for pain treatment than opioids—a dangerous category of pain killers that includes hydrocodone, morphine and fentanyl—without the abuse potential of such medications.
Pharmakon owner, compliance director face criminal charges
The owner and the director of compliance for Noblesville-based Pharmakon Pharmaceuticals Inc. have been charged with multiple criminal counts related to the sale of over-potent compounded painkillers that sickened at least three infants.
Lilly migraine drug provides relief in late-stage trials
Lilly is in a race with several pharmaceutical firms to develop migraine treatments using an approach known as anti-CGRP and that could create a multibillion-dollar market.
Wall Street punishes Lilly for latest drug setback; analysts grasp for answers
News that federal regulators rejected Lilly’s drug for arthritis sent the stock tumbling more than 5 percent Monday, and sent surprised analysts searching for answers.
Lilly’s rheumatoid arthritis pill rejected by regulators
The drug, which has the proposed brand name Olumiant and is approved for use in Europe, was expected to be a big seller.