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EY’s 2025 Biotech Beyond Borders report provides a sobering snapshot of the industry’s financial health, with more and more companies facing cash runways of less than one year. The analyst firm’s leaders urge a return to basics for biotech.
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Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.
Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.
Analysts have had to throw out their assumptions for the biopharma industry’s recovery heading into the first quarter earnings period given the ongoing tariff drama.
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Agios Pharmaceuticals, Inc., a leader in cellular metabolism and pyruvate kinase activation pioneering therapies for rare diseases, announced that the global Phase 3 ENERGIZE-T study of mitapivat in adults with transfusion-dependent alpha- or beta-thalassemia achieved its primary endpoint of transfusion reduction response.
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When talking to some of the most impressive women in biopharma, the conversation inevitably turned to what these women wanted other entrepreneurs to know. Here’s the best of the best of that advice.
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Analysts said the data suggest “a strong treatment effect.” Jazz has filed for FDA approval for the combination, which could offer an alternative to monotherapy treatments from Roche and AstraZeneca.
In comments posted in response to the Trump administration’s pharma tariff investigation, companies and industry groups offered solutions to ease the impacts if the plan must go ahead.
Regeneron’s shares have declined nearly 17% following the failure of the company’s Dupixent follow-up itepekimab.
Blueprint has a next-generation systemic mastocytosis treatment, called elenestinib, that Sanofi CEO Paul Hudson told analysts provides an “opportunity to grow through the ‘30s.”
Bristol Myers Squibb is dropping at least $3.5 billion to jointly develop the bispecific antibody, which will race with Summit Therapeutics, Merck and Pfizer in the crowded PD-1/PD-L1xVEGF space.
AstraZeneca has put hundreds of millions of dollars into AI deals, with an eye toward not just accelerating the development of drugs that treat cancer after it appears but also in creating diagnostics that can catch cancer earlier than current methods allow.
Updated Phase I/Ib data in hand, Arcus will launch a Phase III trial as it aims to compete with Merck, whose drug secured approval for a type of kidney cancer in 2023.
Following Merus’ splash last month with a “best-in-disease profile” for its head and neck cancer bispecific, Bicara touted positive results for its monocolonal antibody, but analysts say Merus still has the upper hand.
Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors worried.
The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, power has shifted from federal agencies to the courts, with potential implications for everything from the FDA shortage list to CMS drug price negotiations.