Specialty pharmacies and online companies that have been selling off-brand copies of two blockbuster drugs for obesity and diabetes will need to phase out their versions next year under a federal decision issued Thursday.
The Food and Drug Administration said that a nationwide shortage of Eli Lillys Zepbound and Mounjaro has been resolved, eliminating the need for copycat versions of the drugs that have become wildly popular with Americans trying to lose weight.
The decision is a win for Lilly which had been pressing the FDA to take the step for months and is expected to impact how patients access the drugs, including how much they pay.
Zepbound is FDA-approved to treat obesity and Mounjaro is approved for diabetes.
They use the same active ingredient, tirzepatide.
The FDA said Thursday that Lillys supply is currently meeting or exceeding demand, after two years of shortages.
Both drugs are part of the GLP-1 class that has shown unprecedented results for helping people shed weight by decreasing appetite and boosting feelings of fullness.
Wegovy and Ozempic competing drugs from Novo Nordisk remain on the FDAs shortage list.
With demand for GLP-1 drugs booming, compounding pharmacies and telehealth companies like Hims and Ro have jumped into the market, selling cheaper versions online.
People can usually get a months supply for several hundred dollars.
Thursdays decision gives businesses between 60 and 90 days, depending on their size, to phase out their products.
The FDA permits compounded versions of brand name drugs when they are in shortage, and the shift back to Lillys medications could improve safety for consumers.
The FDA warned patients last year about problems with the ingredients and formulations of some GLP-1 drugs sold online.
The agency has limited oversight of compounding pharmacies, which are primarily overseen by state authorities.
Compounding pharmacies use raw drug ingredients to produce customized versions of prescription medications for instance, when patients have allergies to certain ingredients.
The industry has grown into a multibillion-dollar business over the past decade amid increasing drug shortages.
Demand for off-brand GLP-1 drugs has been amplified by aggressive online promotions from telehealth companies, which arent subject to the same marketing rules as drugmakers.
The FDA previously declared an end to the shortage of Mounjaro and Zepbound in early October, but reversed its decision after public pushback and a lawsuit filed by compounding pharmacies.
CLEVELAND — How far can a team go by repeatedly dancing away from a season-ending precipice? The Cleveland Guardians are determined to find out.
The Guardians, boosted by a five-run eighth-inning outburst that began with an unlikely home run from Brayan Rocchio, beat the Detroit Tigers6-1 on Wednesday to force a decisive Game 3 in the AL Wild Card Series.
In many ways, it was fitting that Rocchio ignited the season-saving rally because the trajectory of his rags-to-riches season has been in lockstep with the team around him. And, yes, the blast was unlikely, but unlikely is where the Guardians seem to be most comfortable.
“We always say we try to always play without pressure,” Rocchio said through the team’s interpreter. “That’s our type of ball. We just play and we realize we’re going to play until the last out. Even if we’re down by 10, we’ll know we’ll continue to try to play that type of ball.”
For seven innings, the Guardians and Tigers engaged in the kind of low-scoring, close game that frustrates hitters and thrills pitchers alike. For Cleveland, the frustration came from an inability to do much of anything after George Valera‘s first-inning home run. Through seven frames, Cleveland had just two hits and five baserunners overall.
For Detroit, the frustration was very different. The Tigers stranded 15 baserunners for the game. One Cleveland pitcher after another managed to wriggle out of trouble, usually with an inning-ending strikeout.
“It was a tough day,” Tigers manager A.J. Hinch said. “Obviously, they made the most of their opportunities and we left 15 guys on. I think that paints the picture that was today.”
The score was tied 1-1 entering the Cleveland half of the eighth. With one out, Rocchio stepped to the dish against Detroit fireballer Troy Melton.
“Just velo and the plus stuff,” Hinch said when asked why he went with Melton in that situation. “We needed to extend the game.”
Melton might have been the least of Rocchio’s problems. The afternoon shadows make things miserable for the hitters, with Guardians manager Stephen Vogt noting that in those conditions, batters simply can’t pick up the spin on a pitch, making everything look more or less like a fastball.
Rocchio got an actual fastball from Melton, a four-seamer in the heart of the plate that registered at 99.9 mph, per Statcast. The sheer velocity of the pitch was the first thing that made Rocchio’s homer so unlikely. According to ESPN Research, only Oscar Mercado, in a 2020 regular-season game, had gone deep on a pitch that fast for Cleveland over the past decade.
Rocchio connected and sent a shot toward right field. But even so, a home run still seemed very unlikely thanks to a howling wind that had been blowing in from that direction and played havoc with fly balls all afternoon.
“Funny enough, when the game started, I was thinking with this wind, we have to put the ball on the ground, try to get ground balls,” Rocchio said. “When I get that mindset to get the ball on the ground is when I get better and better results.”
Indeed, the ball settled into the right-field seats, giving Cleveland the lead and sparking an offensive surge capped by Bo Naylor‘s three-run blast later in the inning.
But forget the conditions — the shadows, the wind, the pitcher — and just think how unlikely it was that Rocchio was there, taking a high-leverage at-bat in a postseason elimination game.
Rocchio struggled so badly early this season that he spent six weeks at Triple-A despite helping the Guardians to the 2024 AL Central title and becoming a Gold Glove finalist at shortstop.
When Rocchio did return to the majors, his club was on its way to digging a 15½-game hole beneath Detroit in the AL Central. Nevertheless, there they were in Game 2, Rocchio and the Guardians, getting a postseason win in a season that has at various times been on life support.
“I think it’s important to just understand that we’re here for a reason,” Naylor said. “We’re here because we trust the guys that are in that clubhouse at our side.”
The Tigers won’t be daunted by their Game 2 loss, though they will join the Guardians in facing an elimination game Thursday. But if experience in playing with your back against the wall means anything, that edge has to go to a Guardians squad that has been there for three months.
“This is who we are,” Vogt said. “Couldn’t be more proud of our guys. Back against the wall. Back’s still against the wall tomorrow. We’ll come out ready to go and so will they. It will be another dogfight tomorrow. I guarantee it.”
Jackson Merrill hit an early sacrifice fly as San Diego avoided elimination after losing 3-1 on Tuesday. Dylan Cease struck out five in 3 2/3 innings before handing the ball to his team’s hard-throwing bullpen.
The finale of the best-of-three series is back at Wrigley Field on Thursday.
The playoff-tested Padres are looking for a repeat of 2020, when they dropped Game 1 in the special pandemic wild-card round before advancing with two straight victories against St. Louis. Machado also homered in Game 2 of that series.
Chicago finished with four hits. The franchise is making its first appearance in the playoffs in five years, and it hasn’t advanced since it eliminated Washington in a 2017 NL Division Series.
San Diego jumped in front on Merrill’s flyball to right off Andrew Kittredge in the first, driving in Fernando Tatis Jr. Kittredge started for Chicago as an opener, and the right-hander was replaced by left-hander Shota Imanaga in the second.
The Cubs threatened in the fourth, putting runners on first and second with two down. Adrian Morejon then came in and retired Pete Crow-Armstrong on a bouncer to first.
The Padres added two more runs on Machado’s 404-foot drive to left off Imanaga in the fifth. Tatis reached on a leadoff walk and advanced on a sacrifice ahead of Machado’s 12th career playoff homer.
The three runs were more than enough for San Diego’s bullpen, with Miller and Robert Suarez combining for 14 pitches of over 100 mph.
Morejon pitched 2 1/3 perfect innings before Miller showed off his electric stuff while striking out five consecutive batters. The 6-foot-5 right-hander reached 104.5 mph on a called third strike to Carson Kelly in the seventh that was the fastest pitch in the postseason since Statcast started tracking in 2008.
Miller, who was acquired in a trade with the Athletics on July 31, struck out the side in the seventh in his postseason debut on Tuesday. The eight straight Ks tied the postseason record set by Josh Hader in 2022.
Miller was pulled from Game 2 after he hit Michael Busch with a slider with two oust in the eighth. Suarez retired Nico Hoerner on a liner to right before a one-hit ninth for the save.
Up nextYu Darvish will get the ball for San Diego on Thursday. There was no immediate word on Chicago’s starter.
Darvish played for the Cubs for three seasons before he was traded to the Padres in December 2020. The right-hander said he enjoys pitching at Wrigley.
“Yeah, this place did me good,” he said through a translator. “The organization, the fans did me good, too.”
Several boats from a large aid flotilla trying to reach Gaza have been boarded by Israeli authorities – with campaigner Greta Thunberg among those removed.
The Global Sumud Flotilla is made up of more than 40 civilian boats with an estimated 500 people onboard, and is trying to break Israel’s sea blockade.
But the attempt appears to have been thwarted – at least for now – by about 20 Israeli ships.
Israel’s foreign ministry said “several vessels” had been “safely stopped” with passengers being taken to an Israeli port.
“Greta and her friends are safe and healthy,” a spokesperson added.
Image: A livestream showed some of the boats in the flotilla as the incident unfolded
A video showed Thunberg sitting on deck while being handed a water bottle and raincoat.
It’s so far unclear how many boats have been intercepted.
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The flotilla ignored requests to turn back and organisers said the interception was illegal as it happened in “international waters” around 80 miles off the coast.
Greg Stoker, a US veteran who’s involved, said water cannon had been used on some of the boats.
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Gaza-bound flotilla ‘aggressively circled’ by warship
The flotilla, which set off from Barcelona and scheduled to arrive this morning, was flanked by NATO warships for some of the journey.
The attempt has received a lot of attention, with Nelson Mandela’s grandson, a former Barcelona mayor and several European legislators taking part.
Israel said the mission was violating a lawful blockade and is only intended to provoke. It also said it had offered a way to deliver any aid peacefully through safe channels.
Organisers said the night-time interception was the second time the flotilla had been approached on Wednesday, after “warships” earlier encircled two of its boats.
Image: The flotilla set off from Barcelona on 31 August and later stopped in Sicily
Last week, drones also reportedly dropped stun grenades and itching powder on some vessels.
Israel didn’t comment, but has said it will use any means to stop the boats getting to Gaza.
Protests have broken out in Italy and Turkey over the treatment of the flotilla.
Italy’s largest union has called a general strike tomorrow, saying the “attack on civilian vessels carrying Italian citizens represents an extremely serious matter”.
Turkey’s foreign ministry called Israel’s interception an “attack” and “an act of terror” that endangered lives of those on board.
Gaza has been dealing with severe food shortages due to the ongoing war.
Image: Thunberg and activist Saif Abukeshek. Pic: Reuters/Nacho Doce
Agencies such as the UN accused Israel of deliberately slowing the delivery of supplies – something it denies.
However, the aid being carried by the flotilla is said to only be a symbolic amount of food and medicine.
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Will Trump’s Gaza plan bring peace?
Meanwhile, all eyes remain on Hamas and whether it will accept Donald Trump’s peace plan to end the two-year war, sparked by the group’s terror attack on Israel.
The 20-point proposal was unveiled alongside Israeli Prime Minister Benjamin Netanyahu in the White House this week.
Hamas said it would study the plan and consult with other factions, but didn’t give an indication of when it would deliver its verdict.