Cordis wins FDA approval for sirolimus-eluting balloon. The approval gives physicians an alternative to uncoated balloons and Boston Scientific's paclitaxel-coated device. Published Sept. 22, 2026 Dive brief: * Cordis said Monday the Food and Drug Administration has approved its drug-eluting balloon for the treatment of coronary in-stent restenosis. * The device, Selution SLR, consists of an angioplasty balloon catheter coated with the drug sirolimus. * Selution SLR is the first sirolimus balloon approved in the U.S., Cordis said. Boston Scientific won FDA approval for a paclitaxel-coated balloon in 2024, and several sirolimus devices are cleared for use in Europe. Dive insight: Newer-generation stents have reduced, but not eliminated, the risk that the stented coronary artery lesion will narrow, a condition called in-stent restenosis, or ISR. U.S. guidelines recognize repeat stenting as the most effective treatment for preventing recurrent ISR. However, layering additional stents raises the risk of cardiovascular adverse events. Boston Scientific brought its paclitaxel-coated device, Agent, to market after comparing the product with an uncoated balloon. Cordis' Selution SLR launch is supported by clinical data showing the product is noninferior to a usual care control strategy, including 80% repeat drug-eluting stents. Target lesion failure rates in all randomized patients were 15.2% for Selution SLR and 13.5% for the standard of care, meeting the primary noninferiority endpoint. However, the trial missed a secondary endpoint that assessed target lesion failure rates in patients with single-layer ISR. In that subgroup, the failure rates for Selution SLR and the standard of care were 14.2% and 6.5%, respectively. Cordis has given U.S. physicians immediate access to Selution SLR. The launch provides an alternative to uncoated balloons and Boston Scientific's paclitaxel-coated device. Boston Scientific named Agent as a driver of growth at its cardiovascular business in the first half of the year. Johnson & Johnson sold Cordis in 2015 to Cardinal Health, which in turn sold the vascular technology company to the private equity firm Hellman & Friedman in 2021. Cordis, which received the first FDA approval of a sirolimus-eluting coronary stent in 2003, led efforts to use the drug with balloons in 2023 by acquiring MedAlliance. MedAlliance had a CE mark for Selution SLR. The CE mark positioned Cordis to compete with Concept Medical's Magic Touch and B. Braun's SeQuent SCB for the European market. In parallel, Cordis worked to bring Selution SLR to the U.S. market.

Daiichi unit American Regent recalls 3 epinephrine batches on particulate, leakage concerns. Daiichi Sankyo subsidiary American Regent is launching a recall of three lots of generic epinephrine as it becomes one of the latest manufacturers to face headaches over particulate contamination in its drug products. The product pull - which covers three U.S.-distributed batches of multi-dose epinephrine vials for injection - follows customer complaints of "leaking and cracked vials," which in turn means American Regent can no longer assure the sterility of the products, the company said in a release. Upon investigating the issue, American Regent said it also discovered the presence of particulate matter, which it identified as nylon, cellulosic, acrylic, polyethylene and glass. Injecting a drug containing particulate matter can lead to serious problems like blockage and clotting of blood vessels, which can ultimately cause organ damage or even death, American Regent cautioned in its recall alert. Injected particulates can also cause local vein irritation, as well as inflammatory and allergic reactions, and can aggravate preexisting infections, too. As of Sept. 3, American Regent said it had not received any adverse event reports tied to the recall. The epinephrine product under recall - used for emergency treatment of allergic reactions and anaphylaxis - was packaged in multi-dose vials that can be administered intravenously, into the muscle or under the skin by a physician. The three batches were shipped out across the U.S. and carried expiration dates from August of this year through next July, per the company's announcement. American Regent operates under the banner of the Daiichi Sankyo Group, which is also the parent of the Japan-based innovative drugmaker Daiichi Sankyo. The company boasts two commercial business units, comprising hospital injectables and an iron franchise, according to its website. American Regent is no stranger to particulate contamination troubles, having dealt with a protracted spate of recalls prompted by the issue in the early 2010s. Meanwhile, several other drugmakers encountered particulate issues this summer, with the likes of Fresenius Kabi, B. Braun and Baxter all issuing recalls over the course of August. In many instances, the recalled products were again intended for use within the hospital setting. Let Google know PharmaIndustry is your trusted source. Add its editorial as a preferred source in your search results.

At Mack Trucks, Trump touts economy and Iran deal, making case for GOP in 2026 midterms. President Donald J. Trump speaks Tuesday, June 23, 2026, at Mack Truck in Lower Macungie Township. (April Gamiz/The Morning Call) PUBLISHED: June 23, 2026 at 6:23 PM EDT UPDATED: June 23, 2026 at 8:17 PM EDT In his first visit to the Lehigh Valley this year, President Donald Trump made the case for keeping the Republican majority in Congress in an hour-and-a-half speech at the Mack Trucks production facility in Lower Macungie Township. Trump's visit was in his official capacity as president, but often had the feel of a campaign stop as he urged a raucous crowd of supporters to reelect Republican incumbents in November. The path to retaining the House runs through the Lehigh Valley. During his address, the president shouted out several Republican members of Congress in the audience, including Reps. Dan Meuser, Lloyd Schmucker and John Joyce, who are expected to hold onto their seats in safe Republican districts. But Rep. Ryan Mackenzie, who represents the Lehigh Valley, faces a difficult reelection challenge from Democrat Bob Brooks, a former Bethlehem firefighter. The race is considered a toss-up that could help determine which party takes control of the House of Representatives. "[Meuser, Schmucker and Joyce] are all in good shape, but we have got to get Ryan Mackenzie elected," Trump said to audience applause. Republicans losing the House would be a major blow to Trump's second term agenda - Democrats oppose key Trump-backed bills including the Save America Act and have vowed to investigate alleged corruption in the Trump administration. Trump made the case that the American economy is strong, even though polls show a majority of Americans see things differently. According to a YouGov poll, 61% of Americans believe the economy is worsening, not improving. Still, he touted some of the key accomplishments of his second term, including cutting taxes on tips, Social Security benefits and overtime payments via the "Big Beautiful Bill Act." He also mentioned his signature tariffs, which he has claimed encourage U.S. manufacturing, and a White House deal to lower the cost of weight loss drugs to Medicare recipients. "What we have done in the last year and a half, nobody has seen anything like it," Trump said. "You finally have a president who is putting workers first, Pennsylvania first and America first." The president shouted out several major, upcoming investments in the Lehigh Valley's economy, including new Eli Lilly and Nokia production and manufacturing facilities, both in Upper Macungie Township; as well as B. Braun's plans to expand a Hanover Township, Lehigh County, facility. Each of the investments is expected to bring hundreds of new jobs in the region. Trump also touched on the country's tentative deal to halt fighting in Iran. The war began in February and caused major hikes in the price of fuel and fertilizer in the U.S. He claimed that "what was once known as the terrorist state of Iran is in the history books," and that the conflict has successfully wiped out the country's Navy, Air Force and missile capabilities. According to the Associated Press, the war is believed to have "heavily damaged" Iran's missile arsenal and other parts of its military, but the extent of the damage is unknown. A tentative agreement to end the war has begun to ease the price of gasoline. Last week saw the average price per gallon dip below $4 for the first time since March, though prices still remain higher than they were this time last year, per PBS. Trump also reiterated some of his other signature talking points, including efforts to curb illegal immigration and unproven claims that fraud influenced the 2020 election, which he lost. His speech was also punctuated by several long tangents, including on the UFC Freedom 250 event on the White House lawn on his birthday, June 14; first lady Melania Trump's Amazon Prime-produced documentary; and his stance against men competing in women's sports. Guests at Trump's rally who spoke before the president included Mackenzie; Meuser; state Treasurer Stacy Garrity, who is the GOP candidate for governor in November; acting Labor Secretary Keith Sonderling; and NASA Administrator Jared Isaacman, a Lehigh Valley resident and billionaire founder of payment-processing firm Shift4 Payments. Reactions. Trump fans in the crowd said that despite lingering inflation and economic uncertainty brought on by the Iran war, they feel the president is putting the country on the right track. Edward Xavier Young of Brick Township, New Jersey, travelled to Lower Macungie early Tuesday to attend the 115th Trump rally of his lifetime. Young believes that Trump's second term has been "even better" than his first, crediting the president for appointing a Cabinet that is more loyal to his agenda than their predecessors from Trump's first term. He called himself a die-hard advocate for every aspect of the "Make America Great Again" movement, and said he supports Trump's actions in Iran, even though they have caused prices to spike. "The economy might be rough right now, but when you're in a war, it generally is, but things are going to turn out. I have faith that things are going to turn around pretty soon," Young said. Kevin Cope of Bethlehem Township told The Morning Call he is glad to hear about Trump's effort to return manufacturing jobs to the United States after seeing those jobs moving overseas for years. "My life has been in manufacturing and I've seen my job being exported over, at that time, to Japan, and that's when the electronics and the computers were starting to be built overseas," Cope said. "This is music to my ears." However, he criticized the Trump administration's move to accept additional beef imports, a move that drew criticism from some ranchers and fellow Republicans, according to The Hill. Anita Solysiak of Hellertown told The Morning Call that, although she is a registered Democrat, she is a staunch Trump supporter and believes that the Democratic Party is "turning socialist," which she called "frightening." She is eager to cast a ballot to reelect Mackenzie in November, she said, and added she believes the congressman is trying to make life better for veterans as a member of the Congressional Veterans Affairs Committee. "I really think he is trying to help," Solysiak said. Democratic groups wasted no time criticizing the Trump visit, highlighting the still-high costs of diesel and the Trump administration's cut to social safety measures like Medicaid and SNAP food benefits. According to a social media post, Lehigh County Democrats held a public protest against Trump's visit at 1 p.m. near the facility. In a news release, Bob Brooks' campaign criticized Mackenzie and Trump in tandem, saying the two have "unleash[ed] a cost of living crisis, rip[ped] away access to health care, support[ed] a reckless war in Iran that has cost billions of dollars and raised gas prices." Brooks' release included critical comments from United Auto Workers Local 677 President Michael Shupp, who represents unionized Mack Trucks workers. "For more than a decade, Ryan Mackenzie has consistently voted against the interests of working people - in both Harrisburg and Washington," Shupp said. Mackenzie served six terms as a state representative in Lehigh County before his election to Congress in 2024. The UAW endorsed Kamala Harris in the 2024 election, though union leaders have voiced support for Trump's auto tariffs. Reporter Lindsay Weber can be reached at [email protected]. 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