High Court’s Tariff Ruling Likely Won’t Affect Deals Struck With Drugmakers

Managed Healthcare Executive: What Does The Supreme Court Decision Striking Down Tariffs Mean For The Pharmaceutical Industry? 
The Trump administration has other legal avenues to impose tariffs on pharmaceuticals despite the Supreme Court decision striking down many of the administration’s current tariffs. In a 6-3 decision, the court ruled that President Donald Trump did not have the authority to impose tariffs under a 1977 law, the International Emergency Economic Powers Act. But at a White House press conference, Trump said there were numerous other statutes and authorities that give the president the power to impose tariffs. He cited Sections 122 and 301 of the Trade Act of 1974; Section 232 of the Trade Expansion Act of 1962; and Section 338 of the Tariff Act of 1930, commonly referred to as the Smoot-Hawley Tariff Act. He also announced that he would impose a broad tariff of 10% under Section 122 of the Trade Act of 1974, effectively replacing tariffs he imposed under the international emergency law that the court struck down. (Wehrwein, 2/21)

Updates on the FDA —

Stat: Petition Pushes FDA To Exempt AI Devices From Premarket Review 
The Trump administration has promised to reduce the barriers between health artificial intelligence developers and patients. With a provocative new proposal, an AI company has offered regulators a way to let a broad swath of potentially risky AI devices flood the market. (Aguilar and Palmer, 2/23)

Stat: Pharma Lobbyists Focus On A Surprising New Target: The FDA
Health secretary Robert F. Kennedy Jr. has repeatedly promised to root out industry influence from the Food and Drug Administration. But the Trump administration’s injection of political priorities into the agency, which has long been shielded from such meddling, has opened new avenues for lobbying. (Payne and Lawrence, 2/23)

In other pharmaceutical industry news —

FiercePharma: Manufacturing Catalent Cuts Staff By 96 In Another Round Of Layoffs In Maryland
Catalent is cutting more roles at its gene therapy manufacturing facility in Harmans, Maryland. This round of layoffs will affect 93 employees and will be effective on March 19, according to a Maryland Work Adjustment and Retraining Notification (WARN) filing. The state's WARN report also notes the CDMO's dismissal of three other employees in nearby Baltimore. (Dunleavy, 2/20)

Stat: Novo's Obesity Drug CagriSema Falls Short In Trial Versus Zepbound
Novo Nordisk’s next-generation weight loss drug CagriSema, one of the company’s key hopes to help it regain its footing in the increasingly competitive obesity market, failed in a key study that compared it to rival Eli Lilly’s tirzepatide, Novo said Monday. (Joseph, 2/23)

Bloomberg: L’Oréal Played A Key Role In Sanofi CEO Ouster, Successor Pick
L’Oréal SA played a key role in the ouster last week of Sanofi SA Chief Executive Officer Paul Hudson and the choice of his successor, in what was a major corporate shakeup for the French pharmaceutical company. The push by the French cosmetics giant, Sanofi’s biggest shareholder, led to the naming of Merck KGaA CEO Belén Garijo to succeed Hudson, according to people familiar with the matter who didn’t want to be named citing confidential discussions. (Furlong, Rascouet, and Torsoli, 2/20)

Stat: Study On Timing Cancer Treatments To The Morning Comes Under Fire 
The notion that oncologists could boost immunotherapy responses simply by giving infusions in the morning, rather than late afternoon, is an attractive one. So when a clinical trial published in Nature Medicine this month showed that lung cancer patients treated in the morning had a massive reduction in the risk of progression compared to those treated in the afternoon, many scientists were intrigued, if skeptical. Now that study is coming under fire, as multiple scientists and sleuths raise serious concerns about the data and point out inconsistencies in the trial. (Chen, 2/20)