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While Baseline Therapeutics declined to disclose its starting capital, the startup said it will use the funds to push its GLP-1 asset BT-001 into late-stage development, with two trials planned this year.
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Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Despite the strong performance of its cancer portfolio, Johnson & Johnson on Tuesday reported Stelara sales of $2.45 billion in the first quarter of 2024, falling short of Wall Street expectations of $2.6 billion.
In a Phase I/II study, Ultragenyx’s antisense oligonucleotide GTX-102 led to significant cognitive, behavioral, sleep and gross motor improvements in patients with the rare genetic disorder Angelman syndrome.
A federal court in Massachusetts has granted Pfizer and BioNTech’s motion to put on hold Moderna’s lawsuit over alleged patent infringement related to their COVID-19 vaccine Comirnaty.
Prescriptions for Sandoz’s Hyrimoz, a biosimilar version of AbbVie’s Humira, have shot up after CVS Caremark took the blockbuster arthritis treatment off its major national commercial formularies on April 1.
While Madrigal Pharmaceuticals secured the first FDA drug approval for metabolic dysfunction–associated steatohepatitis, Akero Therapeutics is developing what may serve as a viable alternative treatment for precirrhotic disease.
Roche said Monday that its bispecific T cell engager Columvi improved survival in a Phase III lymphoma trial, clearing the drugmaker to seek a full, expanded label that could drive sales growth.
Following cases of convulsions in rabbits in a preclinical study, the FDA has placed a clinical hold on Neumora Therapeutics’ Phase I schizophrenia drug candidate NMRA-266.
Roche’s Genentech subsidiary is terminating for undisclosed reasons its 2021 contract with Adaptimmune for the development of allogeneic T-cell therapeutics.
AbbVie’s small molecule drug Qulipta has durable benefits and can reduce migraine frequency through 48 weeks of follow-up, according to interim Phase III data released on Friday.
An FDA advisory committee on Friday agreed that using minimal residual disease could be a viable surrogate endpoint for accelerated approval for drug development in multiple myeloma.