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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.
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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.
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The state must submit additional information about the drugs it intends to import before the first shipments are sent to the U.S.
The therapeutic targets of many of our top startups are also reflected in recent big biopharma acquisitions and partnerships.
In a major pivot, Allogene Therapeutics will no longer focus on two of its studies testing blood cancer therapy cema-cel in an effort to extend its financial runway into 2026.
While initial public offering activity was light in 2023, the new year has recorded the first IPO plan—from California-based CG Oncology.
Eli Lilly on Thursday announced the rollout of a new digital healthcare platform to streamline consumer access to its weight-loss drug Zepbound and other medications.
With recent scientific advances, milestone approvals and increased dealmaking, the future of treatment for neurological diseases looks brighter—but continued investment, collaboration and patient-focused efforts are key.
The two agreements announced Thursday will allow AbbVie to leverage Umoja Biopharma’s VivoVec delivery platform, which enables patients’ cells to produce their own cancer-fighting CAR-T cells.
The regulator is launching an investigation of Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound and other GLP-1 receptor agonists following patient reports of suicidal ideation, alopecia and aspiration.
In the third deal in as many days, Roche is paying $66 million upfront to MOMA Therapeutics to find new drugs to go after cancer cell growth, with a potential $2 billion total in milestones and royalties.
Wednesday’s settlement resolves a legal dispute between Daiichi Sankyo Europe and Esperion Therapeutics regarding milestone payments under their cardiovascular drug collaboration.