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FEATURED STORIES
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
AVROBIO is planning a Phase II/III registrational trial for its Gaucher Disease Type 3 (GD3) gene therapy candidate, AVR-RD-02, in 2023.
In the heated race for a new respiratory syncytial virus vaccine for older adults, Pfizer gained ground on GSK after winning priority review designation for its vaccine candidate.
Neurocrine’s NBI-827104 failed to meet the primary endpoint in a Phase II study for epileptic encephalopathy with continuous spike-and-wave during sleep, the company announced Tuesday.
Eli Lilly and Boehringer Ingelheim declared another victory Wednesday for Jardiance – this one for children and adolescents with Type 2 Diabetes.
Findings from the Phase II ARTEMIS-UC and Phase IIa APOLLO-CD trials show that Prometheus’ PRA023 is potentially safe and effective for treating ulcerative colitis and Crohn’s disease.
Novartis announced that its Kisqali with endocrine therapy offered almost a year of progression-free survival (PFS) for an aggressive form of HER+/HER2- metastatic breast cancer.
Apogee Therapeutics sprang onto the immunology/inflammatory scene Wednesday heavy on capital but light on salient details of the pipeline.
Karuna Therapeutics appointed Bill Meury as its new president and chief executive officer, succeeding its current head, Steve Paul.
Editas Medicine released positive proof of concept data Tuesday morning from the first patients dosed with its experimental CRISPR-based gene therapy for sickle cell disease.
Entact Bio launched with $81 million Tuesday to advance its protein enhancement platform.