ImmunoGen Antibody-Drug Conjugate Faces Delay After Study Split
Following FDA Guidance
Top-line results from the firm’s pivotal trial of pivekimab sunirine in a rare cancer indication have been delayed for two more years as the firm shifts focus to a specific subpopulation.
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Elzonris: A Case Study In Divergent Regulatory Decisions
Stemline Therapeutics’ Elzonris was approved for a rare cancer in Europe in January, following a long and arduous two-year journey through the EU regulatory process that included an initial rejection and a subsequent re-examination by the EMA. Its fortunes were very different in the US, where the review took just six months from filing to approval.
Double Blow For Sangamo’s Zinc Finger Approach As Novartis And Biogen Deals Collapse
The US biotech is facing yet another setback on its journey to proof-of-concept for its proprietary gene editing technology as two pharma firms back out of collaborations in the neurological space.
Affibody And UCB Eye Humira’s Weak Spot In Hidradenitis Suppurativa
The rival firms are advancing separate biologic candidates that target IL-17 in a bid to treat the more than 60% of hidradenitis suppurativa patients who remain uncontrolled on AbbVie’s Humira, with recent trial readouts showing promise.