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Novo Nordisk and Eli Lilly presented data extolling the benefits of their relative weight loss therapies in obesity-linked indications, while analysts at BMO Capital Markets were “encouraged” by the strategy communicated by Novo management.
After a $625 million IPO, the biggest ever in biotech, obesity-focused Kailera Therapeutics is readying a commercial strategy that puts patients at the center.
FDA
The FDA has expanded the regulatory toolkit during President Donald Trump’s second term, adding new mechanisms for rare diseases while putting the Biden-era platform technology designation into action.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Regulatory challenges have been even more top of mind than usual given recent upheaval at the FDA. BioSpace spoke to three industry experts about key issues, which include applying new artificial intelligence guidance. The experts also shared advice for working with regulators.
Biopharmas are less focused on local job candidates and are more open to recruiting regardless of location, according to the new BioSpace employment outlook report. Even employers who prefer to hire locally would consider remote hires for some roles.
After a series of deaths in patients taking Sarepta Therapeutics’ gene therapies, doubt has crept into investor sentiments around the long-time Wall Street darling, and patients may soon begin looking elsewhere.
In addition to claiming revenue of $19.3 billion for the fourth quarter, Eli Lilly executives offered a glimpse into their strategy to expand their GLP-1 franchise into the immunology and inflammation space, with trials currently underway in asthma, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
Novo Nordisk and Eli Lilly both think the Wegovy pill is doing well, but the American rival sees the successful launch as a harbinger of good news for its own candidate, orforglipron, which is expected to hit the market in the second quarter.
On its fourth quarter earnings call Wednesday, AbbVie CEO Robert Michael called oncology and neuroscience “underappreciated” areas of focus for the pharma.
Novo Nordisk CEO Maziar Mike Doustdar acknowledged the market pressure facing the company’s GLP-1 products but sought to assure investors that Novo has the situation under control.
Amgen believes that it can transcend the expected tradeoff between convenience and efficacy, anticipating that its investigational obesity drug MariTide will continue to provide competitive weight loss even at monthly or longer schedules.
After review, Amgen is certain that Tavneos is effective and has a favorable benefit-risk profile. The company informed the FDA on January 28 that they would not pull the drug.
Instead of joining the increasingly crowded GLP-1 arena, GSK will focus its efforts downstream of obesity—a push currently anchored by its Phase III-ready FGF21 analog efimosfermin alfa for liver fibrosis.