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CSL is advancing clazakizumab for the treatment of cardiovascular events in end-stage kidney disease and will retain rights over the asset in this indication. Lilly will explore other conditions.
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An analysis finds that pharmas frequently file multiple similar patents on drugs, then use them as the basis for questionable litigation against would-be competitors.
Competing with giants like Takeda and Moderna, the plucky biotech believes it has unlocked a future with an easy, yearly oral vaccine.
The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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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.
Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir.
Here’s how companies can ensure they’re in compliance with new requirements that go into effect in August.