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With the failure in chronic spontaneous urticaria, Evommune’s story is now centered on its anti-IL-18 therapy EVO301, Oppenheimer said, which in February elicited a 33% placebo-adjusted improvement in eczema severity.
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Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety study, as had been feared, Jefferies analysts said Monday.
In a Phase Ib/IIa trial, 91% of patients receiving the highest dose of trontinemab were amyloid negative after seven months of treatment, representing what B. Riley Securities called a “paradigm shift” to first-generation FDA-approved antibodies.
The German giant is looking to develop new drugs for undisclosed eye diseases using Re-Vana’s extended-release injectable platform to supply drugs to the eye for months at a time.
The star of GSK’s Hengrui partnership is the COPD candidate HRS-9821, which will complement the pharma’s respiratory pipeline that’s anchored by the anti-asthma drug Nucala.
Health Secretary Robert F. Kennedy Jr. wants to remove all members of the USPSTF for being too “woke,” according to reporting by the Wall Street Journal. An HHS spokesperson, however, says no final decision has been made about the panel.
Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe infection exacerbated by immunosuppression.
Despite the failure of its Recognify-partnered inidascamine, Jefferies analysts do not expect a definitively negative stock impact on atai, given the company’s promising psychedelic pipeline.
Acknowledging the limits of disease-modifying drugs like Leqembi and Kisunla, companies like Bristol Myers Squibb, Acadia, Otsuka and Lundbeck are renewing a decades-old search for symptomatic treatments, including in high-profile drugs like Cobenfy.
These five upcoming data drops could usher in more effective and convenient therapies for Alzheimer’s disease and open up novel pathways of action to treat the memory-robbing illness.
The Commissioner’s National Priority Vouchers aim to offer accelerated pathways to drugs that meet certain criteria, perhaps including a low price-tag. But the policy is vaguely defined and was announced without public input, going against the FDA’s own published practices, experts say.