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Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.
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The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
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After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its COVID-19 shot, CEO John Jacobs said on the company’s Q1 earnings call: “When we have it, we’ll have it. Until then, we don’t have it.”
The cell engineering company, co-founded by oncologist and writer Siddhartha Mukherjee, does not see a path forward for its pipeline of early-stage cell therapies for two different types of cancer.
The biopharma job market likely won’t turn around until 2026, according to two industry experts. Both cited a need for more investment and noted the impact of uncertainty on the industry.
Takeda’s Julie Kim argues that Trump’s idea to match drug prices to that of other countries could cost the industry up to $1 trillion over the next 10 years.
Gilead will construct three new facilities in the U.S., while upgrading three others. The company claims the investment will produce "$43 billion in value.”
The Massachusetts biotech will focus its efforts and resources into cemsidomide, an oral drug candidate being trialed for multiple myeloma and non-Hodgkin lymphoma.
CRISPR Therapeutics’ partner Vertex reported that more than 65 treatment centers have been activated for the gene therapy Casgevy. While Vertex handles the market, CRISPR has been focused on its clinical program.
The FDA in February formally declared the end of the semaglutide shortage, which Novo Nordisk expects will help improve the market position of Wegovy. But Eli Lilly’s Zepbound is quickly gaining ground, with sales just $300 million behind Wegovy in Q1.
Imports of pharmaceutical products surged in March, most of which came from Ireland, historically one of the biggest exporters of medicines to the U.S.
A new executive order aims to smooth the path for getting U.S. manufacturing facilities up and running; HHS says it will require placebo-controlled trials for all vaccine approvals; tariff threats hit BioNTech; Novo Nordisk’s FDA application for an oral version of Wegovy is accepted; and more.