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Poplar Therapeutics is seeking a “step change” in the treatment of food allergy and other atopic conditions, with $95 million raised to date, including a $45 million series A extension that closed Tuesday.
Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche planning to manufacture GLP-1 therapies there to compete in the growing market.
Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its leadership, workforce and policies.
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Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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The vaccine maker previously revealed plans to slash R&D budget to conserve cash for product launches, but after a rough year of consistent share value decline, analysts remain skeptical.
The Phase III win could help Regeneron and Bayer expand into retinal vein occlusion, a move that the partners need to help shore up sales of their Eylea franchise amid biosimilar encroachment.
Both vibostolimab and favezelimab have had disappointing runs leading up to their termination, sustaining several late-stage failures.
The FDA cited issues with a manufacturing facility as the reason for the rejection. J&J is currently “working closely” with the regulator to resolve these problems.
Businessman and entrepreneur Mark Cuban recently discussed leadership with Leadership Lab columnist Michael Pietrack. The three lessons that came out of that conversation start with one word: caring.
Bristol Myers Squibb aims to generate around $1.5 billion in savings through 2025—a goal that it hopes to reach by lowering third-party expenditures, focusing only on key growth brands and cutting some 2,200 jobs by year-end.
The FDA has put a stop to U.S. initiation of PepGen’s Phase II trial for its Duchene muscular dystrophy treatment. The company faced the same hurdle for an earlier neuromuscular candidiate in 2023.
Novo’s latest investment comes just days after the U.S. FTC greenlit the highly contentious acquisition of Catalent, which analysts expect will help the pharma expand its production capacity.
The Nimble acquisition, which follows the $1.4 billion buy of Aliada Therapeutics in October, will help AbbVie rebuild and cement its long-term growth prospects following the Phase II failure of emraclidine in schizophrenia and in anticipation of market erosion for Skyrizi and Rinvoq, according to Guggenheim Partners analysts.
Now that they’ve received the go-signal from both U.S. and EU anti-trust regulators, Novo Holdings and Catalent expect to wrap up their deal in the coming days.