Drug Delivery
FDA Commissioner Marty Makary talks about his plans to revamp drug development and reduce ‘conflicts of interest’ between the agency and pharma industry; Roche and Regeneron jump on the U.S. manufacturing train as Trump’s tariffs loom; and Eli Lilly scores a big win for orforglipron while Novo Nordisk reveals it has applied for FDA approval of its oral semaglutide.
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With crucial lessons learned from the manufacturing shortages of injectable GLP-1s, experts say securing adequate supply of the upcoming oral options will be the sector’s next great challenge.
Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of branded biologics looking to maintain blockbuster revenue.
The ongoing conflicts between Ukraine and Russia, as well as Israel and Palestine, have sent ripples across various industries, including pharma. Medical science liaisons can help.
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Pharma’s reprieve from Donald Trump’s tariffs is expected to be temporary, with Leerink analysts anticipating possible sector-specific duties “in the next month or so.”
Trump has repeatedly called April 2 “Liberation Day,” alluding to a more sweeping and aggressive set of tariffs. Leerink Partners analysts said that the risks from Trump’s tariffs on the biopharma industry are “underappreciated.”
Compounded versions could make up as much as 40% of the semaglutide market, said Novo Nordisk CEO Lars Fruergaard Jorgensen on Thursday, but the company hopes to win patients over.
Eli Lilly and Novo Nordisk are in a global battle for dominance in the weight loss space. BioSpace takes a look at the territory covered and what’s to come.
Johnson & Johnson follows Eli Lilly in spending billions on U.S. manufacturing after President Donald Trump threatened major tariffs on pharmaceutical products. Pfizer has also promised a similar commitment.
Johnson & Johnson and Legend Biotech hope to hit blockbuster status for Carvykti this year.
According to Judge Kenneth Bell, there is a lack of evidence to conclude that Merck willingly misrepresented the safety of its HPV vaccine Gardasil to patients and prescribers.
Analysts acknowledged the long-term manufacturing deal could dull Viking’s takeout prospects but hailed it as a smart move to ensure supply.
Novo Nordisk is intervening in the lawsuit filed by a drug compounders trade group against the FDA over the agency’s decision to declare the Wegovy shortage over. Eli Lilly did the same in a parallel case over Zepbound’s removal from the FDA shortage list and this week a judge denied the compounders’ injunction.
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors.