Lilly seeking FDA approval for new antibody it says works against omicron
In December, the U.S. government paused distribution of Lilly’s two previous antibodies, saying they did not appear effective against the omicron variant.
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Pfizer asks FDA to allow COVID-19 vaccine for kids under 5
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.
Mediator: Purdue Pharma close to reaching new settlement
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.
Michigan AG seeks to investigate Eli Lilly for high insulin prices
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.
Pfizer begins testing omicron-matched COVID shots in adults
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.
FDA expected to sharply restrict use of monoclonal antibodies made by Lilly, Regeneron
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.
COVID-19 pill rollout stymied by shortages as omicron rages
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 limits coverage of $28,000-a-year Alzheimer’s drug
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.
Medicare told to reassess premium hike caused by Alzheimer’s drug
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.
U.S. sends states monoclonal antibodies that might not work against omicron
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.
Eli Lilly inks R&D pact with Canadian pharma company
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.
Merck paying $780M to acquire Indianapolis drug manufacturer
Germany-based pharmaceutical giant Merck on Thursday announced it has signed a definitive agreement to buy Indianapolis-based drug contract manufacturer Exelead Inc.
Doctors bemoan limited supply of game-changing antiviral pills amid winter surge
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.
FDA expands Pfizer boosters for more teens as omicron surges
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.
Lilly’s osteoporosis drug faces generic challenge from Indian drugmaker
Eli Lilly’s blockbuster drug for osteoporosis, Forteo, could face generic competition from Indian drugmaker Sun Pharmaceuticals if the company can get a federal judge to declare that a Lilly patent won’t be infringed.
New easy-to-use COVID-19 pills require early use
The challenge for possible users is getting tested, getting a prescription and starting the pills in a short window.
FDA authorizes Merck’s anti-coronavirus pill, a second treatment option
Molnupiravir cut the risk of hospitalization and death in high-risk patients by 30%. In contrast, Pfizer’s antiviral drug, authorized on Wednesday, reduced hospitalizations and death by nearly 90%.
Pfizer pill becomes first U.S.-authorized home COVID treatment
The drug, Paxlovid, is a faster, cheaper way to treat early COVID-19 infections and head off the worst effects of the virus. But initial supplies will be extremely limited.
French biotech firm expanding to Brownsburg, planning $15M facility
Orano Med LLC says the facility will be used to manufacture and distribute radiopharmaceuticals to treat cancer at hospitals throughout the country.
Omicron may sideline Lilly, Regeneron antibody drugs against COVID-19
The companies say they can quickly develop new omicron-targeting antibodies, but those aren’t expected to launch for at least several months.