The Indianapolis-based pharmaceutical company said the facility is part of its strategy to advance RNA-based therapeutics and builds on its acquisition of Prevail Therapeutics, a gene therapy company based in New York.
The Indianapolis-based drugmaker said the antibody is effective against the omicron variant and it has already manufactured several hundred thousand doses. The deal calls for the federal government to pay Lilly more than $720 million.
U.S. regulators on Friday put the brakes on their push to speed Pfizer’s COVID-19 to children under 5, creating major uncertainty about how soon the shots could become available.
The FDA has agreed to speed up review of donanemab, but the Centers for Medicare and Medicaid Services is moving to limit reimbursement for drugs in this class to only patients in clinical trials.
The deal calls for the federal government to pay Eli Lilly and Co. more than $720 million for the antibody, which the company said is effective against all COVID-19 variants.
Efforts to lower prescription drug costs have long been popular with voters, but bipartisan consensus has proved elusive. It’s unclear if there’s a political path forward for Biden’s plans in Congress.
In December, the U.S. government paused distribution of Lilly’s two previous antibodies, saying they did not appear effective against the omicron variant.
If regulators agree to the long-awaited move, Pfizer shots containing just one-tenth of the dose given to adults could be dispensed to children as young as 6 months.
A judge said in a court filing Monday that members of the Sackler family would contribute a “substantial additional consideration” above the $4.5 billion in cash and charitable assets they’ve already agreed to pay as part of a deal.
Indianapolis-based Eli Lilly and Co., one of three primary U.S. insulin manufacturers, said it was “deeply disappointed by the false accusations and inaccurate claims” made by the attorney general.
The new U.S. study will include up to 1,420 volunteers ages 18 to 55 to test the updated omicron-based shots for use as a booster or for primary vaccinations.
The Food and Drug Administration is poised as soon as Monday to restrict two monoclonal antibodies, saying the COVID-19 treatments should not be employed in any states because they are ineffective against the dominant omicron variant, according to two senior administration health officials.
Two brand-new COVID-19 pills that were supposed to be an important weapon against the pandemic in the United States are in short supply and have played little role in the fight against the omicron wave of infections.
Medicare officials stressed Tuesday that they did not take cost into account in the coverage decision, but rather whether Aduhelm is “reasonable and necessary” for treating Alzheimer’s patients enrolled in the program.
U.S. health secretary Xavier Becerra on Monday ordered Medicare to reassess a big premium increase facing millions of seniors this year, attributed in large part to a pricey new Alzheimer’s drug with questionable benefits.
The federal government has resumed shipping all three monoclonal antibody treatments—including one made by Indianapolis-based Eli Lilly and Co.—that are authorized for early-stage COVID-19 to states despite evidence that two might be ineffective against the omicron variant.
Indianapolis-based Eli Lilly and Co. will make an initial $50 million payment to Entos Pharmaceuticals. Entos also could receive up to $400 million in potential milestone payments, as well as royalties, for successful products.
Germany-based pharmaceutical giant Merck on Thursday announced it has signed a definitive agreement to buy Indianapolis-based drug contract manufacturer Exelead Inc.
Easy-to-take antiviral pills, authorized just before Christmas, were hailed as a potential turning point in the fight against the coronavirus because of the medicines’ ability to keep high-risk people out of the hospital.
Boosters already are recommended for everyone 16 and older, and federal regulators on Monday decided they’re also warranted for 12- to 15-year-olds once enough time has passed since their last dose.
