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Roche said the Phase II results help build the case for advancing CT-388 into late-stage testing, which is set to get underway this quarter.
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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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Dry promotions include new titles and responsibilities without higher pay. What should you do if you’re offered this type of promotion?
On this episode of Denatured, Lori Ellis and guests discuss President Biden’s Executive Order on Advancing Women’s Health Research and Innovation and the outlook of investment in women’s health.
Looking for a biopharma job in the Boston area? Check out these top five companies hiring life sciences professionals like you.
A new BioSpace report finds that life science professionals are prioritizing diversity less when job hunting. Still, DEIB programs don’t appear to be going anywhere.
This discussion features DEIB leaders from California Life Sciences, MassBio, Eli Lilly and Takeda. We explore changing attitudes in the life sciences workforce, if organizations are adjusting either their DEIB or communication strategies, and how evolving philosophies around DEIB are impacting human resources and talent acquisition activities.
We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system
In a fireside chat at the American Society of Gene & Cell Therapy conference, CBER Director Peter Marks spoke with Takeda’s Kristin Van Goor about how the regulator is approaching the exploding gene therapy space.
While Teva missed Wall Street expectations in the first quarter of 2024, it reported Wednesday a 5% increase in Q1 revenues while reporting that the company’s schizophrenia candidate scored a late-stage trial victory
Regeneron Pharmaceuticals on Wednesday revealed that its investigational gene therapy DB-OTO restored hearing in two young children, according to an oral presentation at the American Society of Gene & Cell Therapy annual meeting.
Amylyx’s recent decision to withdraw its ALS drug Relyvrio from the market highlights an important business decision for companies: when to continue marketing or investigating a drug that has failed a pivotal or confirmatory study.