By TOM MURPHY and MATTHEW PERRONE, Associated Press

Federal regulators are trying to make it easier to develop cheaper alternatives to powerful drugs that many Americans depend on to treat autoimmune diseases or cancers.

The Food and Drug Administration said Wednesday it has released guidance to simplify studies for biologic drugs and cut unnecessary testing.

Biologic drugs are made from living cells instead of by mixing chemicals. They have led to major advances in treating immune system disorders, eye diseases and some cancers since the late 1990s, but they also are very costly.

For decades, biotech drugmakers argued that their medicines were too complex to be copied by competitors. That finally changed under President Barack Obama’s 2010 health overhaul, which ordered the FDA to create a system for approving “biosimilar drugs.” The industry term arose because scientists insisted it would be impossible to produce exact copies of their biotech drugs.

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FDA’s pathway, finally published in 2015, suggests that drugmakers conduct studies showing patients respond similarly to biosimilar versions when compared with the originals.

The latest proposal seeks to ease that standard, which the administration calls an “unnecessary resource-intensive requirement.”

“The result will be more competition, lower prices and faster access to lifesaving medicines,” said Health Secretary Robert F. Kennedy Jr.

The draft guidance is the first step in an extensive bureaucratic process. It amounts to a tentative set of recommendations for drugmakers.

The FDA will take public comments on its proposal for 60 days. After that, it must review and revise the document. The final guidance, expected in three months to six months, will not be binding. It will serve as suggestions for drugmakers working on biosimilars.

Biosimilar competition has brought some price relief to patients who take such drugs such as the autoimmune disease treatment Humira. But this may not happen immediately. That can depend on insurance coverage and whether the biosimilar is added to a pharmacy benefit manager’s list of covered drugs.

Experts say that over time, biosimilars also can prompt drugmakers to lower the cost of their biologic drugs or offer bigger rebates to keep their product on a formulary.

Associated Press writer Ali Swenson contributed to this report.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

By DAVID A. LIEB, SARA CLINE, BRIAN WITTE and OLIVA DIAZ, Associated Press

Republican lawmakers in Louisiana and Democrats in Virginia pressed ahead Wednesday with plans that could allow mid-decade redistricting as part of a growing national battle for partisan advantage in next year’s congressional elections.

Louisiana lawmakers passed legislation pushing back the state’s 2026 primary elections by a month — a move that could give lawmakers extra time to redraw the state’s U.S. House districts if the Supreme Court strikes down the current boundaries.

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Meanwhile, Virginia lawmakers were considering a proposed constitutional amendment that, if ultimately approved by voters, would allow lawmakers to temporarily bypass a bipartisan redistricting commission and redraw congressional districts in response to similar efforts in other states.

President Donald Trump triggered a redistricting fray this summer by calling upon Republican-led states to take the unusual step of redrawing U.S. House districts to their advantage ahead of the midterm elections. Redistricting typically occurs once a decade, immediately after a census. But Trump hopes that redistricting now can help Republicans in next year’s midterm elections hold on to the House, where Democrats need to gain just three seats to win control and impede Trump’s agenda.

Republicans in Texas, Missouri and North Carolina already have revised districts at Trump’s urging, and Republican-led Indiana is to begin a special legislative session Monday on redistricting. So far, California is the only Democratic-led state to counter with a new congressional map, which is going before voters in a special election that concludes Tuesday.

Louisiana delays elections for potential redistricting

Legislation delaying Louisiana’s congressional primary from April 18 to May 16 passed along party lines Wednesday during a special session and is expected to be signed into law by Republican Gov. Jeff Landry.

While Louisiana’s election dates have been adjusted before due to hurricanes, this particular change is in anticipation of a Supreme Court ruling in a potentially far-reaching redistricting case. At issue is Louisiana’s six-district congressional map, where lawmakers created a second majority-Black district in response to a previous court ruling, ultimately flipping a reliably Republican seat to Democrats.

FILE – Louisiana Gov. Jeff Landry records a social media video outside the White House, March 24, 2025, in Washington. (AP Photo/Mark Schiefelbein, file)

Proponents of the current map say it offers the opportunity for fair representation in a state where Black residents account for one-third of the population. Opponents argue that the state’s second Black majority congressional district was unconstitutionally gerrymandered based on race.

During arguments earlier this month, the Supreme Court’s six conservative justices appeared inclined to effectively overturn the district boundaries. It’s unclear when a ruling will come.

Virginia Democrats eye a path to more House seats

Democrats hold a 6-5 edge over Republicans in Virginia’s U.S. House delegation. A new map could allow them to expand that advantage. But it requires a multistep process because a voter-approved constitutional amendment places redistricting in the hands of a bipartisan commission.

Republican gubernatorial candidate and current Lt. Gov. Winsome Earle-Sears speak during a news conference on the steps of the Virginia Capitol Building, Monday, Oct. 27, 2025, in Richmond, Va. (Mike Kropf/Richmond Times-Dispatch via AP)

After the 2020 census, that commission deadlocked, so a court imposed districts that remain in use. The Virginia House on Wednesday was considering a proposed constitutional amendment that would allow the legislature to draw new congressional districts in response to mid-decade redistricting done in other states. But lawmakers must approve that amendment in two separate legislative sessions before it can be placed on a statewide ballot.

So far, Democrats haven’t unveiled plans for how those new districts would be shaped.

A lawsuit brought by Republicans contends the special session on redistricting violates the state constitution.

Sen. Ryan McDugall, R-Hanover, speaks during a special legislative session, Monday, Oct. 27, 2025, in Richmond, Va. (Mike Kropf/Richmond Times-Dispatch via AP)

Maryland’s Senate refuses to take up redistricting

Democratic Senate President Bill Ferguson said his chamber won’t move forward with congressional redistricting, even though Democratic Gov. Wes Moore and the state’s Democratic House speaker have expressed interest in it. Maryland Democrats already hold a 7-1 edge over Republicans in the U.S. House.

Ferguson wrote in a letter Tuesday night to Senate Democrats that a redistricting effort aimed at picking up the seat held by Republican U.S. Rep. Andy Harris could jeopardize other seats now held by Democrats and prompt even more Republican-led states to retaliate with their own redistricting.

“In short, the risk of redrawing the congressional map in Maryland is too high, making the unlikely possibility that we gain a seat not worth pursuing,” Ferguson wrote.

He noted that a congressional map adopted in 2021 was ruled unconstitutional by a judge who described it as “a product of extreme partisan gerrymandering.”

Maryland passed another map in 2022, and the parties dropped their legal fight before the new map was reviewed by the court. Redrawing districts again “could reopen the ability for someone to challenge the current map and give the court the opportunity to strike it down, or even worse, redraw the map itself,” Ferguson wrote.

Five of the judges on the seven-member Maryland Supreme Court were appointed by Republican former Gov. Larry Hogan.

Illinois lawmakers remain reluctant to redistrict

Though national Democrats are pressing Illinois to redraw its U.S. House districts, Democrats in the state General Assembly say they won’t take up the topic while in session this week. They left open the possibility to do so later.

Democrats hold 14 of the state’s 17 U.S. House districts, which already were drawn to favor Democrats after the 2020 census. The Democratic Congressional Campaign Committee said it provided a proposed new map to legislative leaders last week that could allow Democrats to win an additional seat.

U.S. House Minority Leader Hakeem Jeffries traveled to Illinois on Monday to meet with Democratic state lawmakers about redistricting, and the state’s Democratic Congress members released a statement Tuesday urging state lawmakers to seriously consider a new map.

But some state lawmakers remain concerned that redrawing districts could weaken the representation of Black voters.

“We can’t casually talk about redrawing maps,” Democratic state Rep. Kam Buckner said Wednesday. “We have to remind folks that those lines aren’t just political boundaries. They are the visible record of invisible battles; they represent neighborhoods that finally got a voice after a century of being spoken for instead of behind heard.”

Lieb reported from Jefferson City, Missouri; Cline from Baton Rouge, Louisiana; Witte from Annapolis, Maryland; and Diaz from Richmond, Virginia.

By BARBARA ORTUTAY

Character.AI is banning minors from using its chatbots amid growing concerns about the effects of artificial intelligence conversations on children. The company is facing several lawsuits over child safety, including by the mother of a teenager who says the company’s chatbots pushed her teenage son to kill himself.

Character Technologies, the Menlo Park, California-based company behind Character.AI, said Wednesday it will be removing the ability of users under 18 to participate in open-ended chats with AI characters. The changes will go into effect by Nov. 25 and a two-hour daily limit will start immediately. Character.AI added that it is working on new features for kids — such as the ability to create videos, stories, and streams with AI characters. The company is also setting up an AI safety lab.

Character.AI said it will be rolling out age-verification functions to help determine which users are under 18. A growing number of tech platforms are turning to age checks to keep children from accessing tools that aren’t safe for them. But these are imperfect, and many kids find ways to get around them. Face scans, for instance, can’t always tell if someone is 17 or 18. And there are privacy concerns around asking people to upload government IDs.

Character.AI, an app that allows users to create customizable characters or interact with those generated by others, spans experiences from imaginative play to mock job interviews. The company says the artificial personas are designed to “feel alive” and “humanlike.”

“Imagine speaking to super intelligent and lifelike chat bot Characters that hear you, understand you and remember you,” reads a description for the app on Google Play. “We encourage you to push the frontier of what’s possible with this innovative technology.”

Critics welcomed the move but said it is not enough — and should have been done earlier. Meetali Jain, executive director of the Tech Justice Law Project, said, “There are still a lot of details left open.”

“They have not addressed how they will operationalize age verification, how they will ensure their methods are privacy preserving, nor have they addressed the possible psychological impact of suddenly disabling access to young users, given the emotional dependencies that have been created,” Jain said. “Moreover, these changes do not address the underlying design features that facilitate these emotional dependencies – not just for children, but also for people over the age of 18 years.”

More than 70% of teens have used AI companions and half use them regularly, according to a recent study from Common Sense Media, a group that studies and advocates for using screens and digital media sensibly.

By DANIELLA MATAR and COLLEEN BARRY, Associated Press

MILAN (AP) — With 100 days to go until the start of the Milan-Cortina Winter Olympics, preparations are going right down to the wire.

The ice hockey arena that is set to welcome back NHL players to the Olympics is still not ready and won’t be tested until less than a month before the first puck is dropped at the 2026 Games.

“There are some things that we are paying more attention to, monitoring them and then there are others that are absolutely completely ready,” Milan-Cortina organizing committee president Giovanni Malagò told journalists outside an event to celebrate the 100-day countdown on Wednesday.

“Being completely honest I would say that these 100 days are necessary, we need them but I don’t think that’s any different than any other big event, you always see people working even hours before the start to ensure it meets expectations.”

Readiness of the venues is not a new concern for the local organizing committee, which rebuilt the century-old sliding track in Cortina after tangling with the International Olympic Committee at length over the decision.

The controversial track is up and running, with the IOC even saying recently that the venue has “surpassed expectations.” It secured preliminary certification in March and test events are taking place through November.

“The sliding center was a very complicated item in that period. It is clear that we respected our promises. It was not so easy to obtain the faith from the international community — my colleagues in the IOC, the international federations,” Malagò said.

“They did a fantastic job and now we want to meet the same expectations with Santagiulia.”

However, a test event at the Santagiulia Ice Hockey Arena — the new, 16,000-seat venue that is being built on the outskirts of Milan — had to be moved, and new ones won’t be until Jan. 9-11.

The first Olympics match at the main hockey arena is the women’s preliminary round competition on Feb. 5, just one day before the opening ceremony.

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“We are convinced that we will have a beautiful facility, and we will be ready to do the test event the first week of January, which will be very important because it has never been used,” Milan-Cortina CEO Andrea Varnier said.

“We need to test the ice, which is temporary not permanent, and also the function of the entire facility, which will be heavily visited.”

There are fewer concerns over other sites as the Milan-Cortina Games will be using mainly existing venues, with this the first Olympics to fully embrace cost-cutting reforms installed by former IOC President Thomas Bach.

That means that it will also be the most spread-out Winter Games in history.

But “the credibility of the venues,” Malagò said, compensates for the distance.

“What is fundamental is that the athletes want to compete in what is the temple of their own discipline. All these events have a recognized, first-class ranked venue … for me it was a good choice and I think for the athletes too,” he said.

Ticket sales

The 100-day mark launched the final phase of ticket sales.

Varnier said they have exceeded their own forecasts, selling more than 850,000 tickets to date. “Many sessions are sold out,’’ he said. In all, Milan-Cortina organizers are selling 1.4 million tickets for both the Feb. 6-22 Olympic Games and for the Paralympics running from March 6-15.

Podium party

Organizers also unveiled the two podiums for the Winter Olympics and Paralympics, the last of the design objects created for the Milan-Cortina Games after the medals, torches and posters.

The low-rise podiums are in a deep blue, with graphic elements meant to recall snow and ice. During the presentation, the two mascots, Tina and Milo, symbolically mounted the podiums.

A pair of stoat — or weasel — siblings, all-white Tina represents the Olympic Winter Games, while Milo, whose coat is brown, is the mascot for the Paralympic Winter Games.