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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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A Delaware judge on Wednesday agreed with Roivant subsidiary Arbutus and Genevant’s interpretation of specific patent claims regarding the lipid nanoparticle delivery system used by Moderna’s COVID-19 vaccine.
Sanofi has in principle reached a settlement related to its discontinued heartburn drug Zantac, though the French pharma did not disclose the financial terms of the deal.
Congress and the Biden administration have set their sights on lowering prescription drug costs.
Fierce competition. Thin pipelines. Patent cliffs. The stakes are sky-high for pharmaceutical companies and investors alike.
Looking for a biopharma job? Check out the BioSpace list of 11 top companies hiring life sciences professionals like you.
There are several ways you can maintain a good working relationship with your boss, starting with learning your manager’s work style, preferences and priorities.
The Cambridge-based biotech was co-founded by Atlas Ventures and CEO Alex Lugovsky to develop agonist antibodies for rare diseases, with a lead program in hereditary hemorrhagic telangiectasia.
The four highest doses of Eli Lilly’s blockbuster diabetes treatment Mounjaro will be in short supply through the rest of the month due to strong demand, according to the regulator.
Acorda Therapeutics becomes the latest biotechnology company in 2024 to go bankrupt and shutter its business, following years of financial difficulty. Merz Therapeutics will acquire two commercial medicines from Acorda for $185 million.
After sustaining a regulatory defeat in insomnia, Vanda Pharmaceuticals on Tuesday won the FDA’s approval for its atypical antipsychotic Fanapt for the treatment of manic or mixed episodes in adults with bipolar I disorder.