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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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Read our takes on the biggest stories happening in the industry.
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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IFM Therapeutics announced Wednesday its subsidiary IFM Due has been acquired by Novartis. The acquisition provides the Swiss pharma with full rights to IFM Due’s portfolio of STING antagonists targeting inflammation-driven diseases.
Heather, Greg and Tyler discuss a busy news week including Wegovy’s label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact.
Eli Lilly has partnered with Amazon Pharmacy to help fill online orders of its obesity drug Zepbound—as well as migraine and diabetes medicines—placed through the pharma’s online portal LillyDirect.
This is the latest rundown of people coming and going from executive positions at biopharma companies that BioSpace covers. This regular column highlights the hired, fired, retired, promoted or resigning, as well as those personally named in lawsuits.
Allogene Therapeutics and Arbor Biotechnologies will use their allogeneic CAR T and next-generation gene-editing platforms to develop novel off-the-shelf CAR-T therapies for autoimmune diseases.
In a briefing document for Thursday’s advisory committee meeting, the FDA pointed to efficacy and safety issues with Geron’s New Drug Application for imetelstat in myelodysplastic syndromes.
A controversial decision by the Alabama Supreme Court temporarily chilled IVF before igniting nationwide pushes to protect access to this type of fertility treatment, leaving drugmakers with questions.
Vertex and CRISPR Therapeutics are setting up treatment centers for patients with beta thalassemia and sickle cell disease to compete with bluebird’s established infrastructure.
Synthetic biology company Pearl Bio announced Tuesday it has entered into a license and collaboration agreement with Merck to discover biologic therapies comprising non-standard amino acids.
The FDA plans to convene an advisory committee meeting to discuss the safety profile and efficacy of Eli Lilly’s Alzheimer’s candidate, the company announced Friday.