Alzheimer's FDA approval, atopic dermatitis data, new Alzheimer's studies, and more..
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CLINICAL TRIAL NEWS
ASLAN Pharmaceuticals
Announced topline data from their Phase 2b dose-ranging study of eblasakimab in adult patients with moderate-to-severe atopic dermatitis (AD). Plans to initiate a phase 3 study in 2024.
C4 Therapeutics
FDA has cleared the company’s IND application for CFT8919 for non-small cell lung cancer (NSCLC) patients. They expect to initiate clinical trial activities outside Greater China following the completion of partner Betta Pharmaceuticals’ Phase 1 dose escalation study in Greater China.
Ayala Pharmaceuticals
Concluded an End-of-Phase-2 (EOP2) meeting with the FDA and confirmed that it is in agreement with the FDA on key elements of the randomized Phase 3 segment of RINGSIDE for the treatment of desmoid tumors. Recruitment is continuing globally.
Cognition Therapeutics
The first clinical trial site has been activated and will begin recruiting participants for the 540-patient Phase 2 START study of CT1812 in adults with early Alzheimer’s disease. Approximately 50 sites in North America have been activated by the Alzheimer's Clinical Trials Consortium (ACTC).
REGULATORY NEWS
Biogen and Eisai
FDA approved the sBLA for traditional approval of LEQEMBI, the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD). Read about 10 potential opportunities for biopharma vendors.
Sarepta Therapeutics
Completed the sale of their Rare Pediatric Disease Priority Review Voucher (PRV). Sarepta received a payment of $102 million upon completion of the sale.
MediWound
Received positive advice from the CHMP within the EMA related to the development plan for the company’s Phase 3 study of EscharEx in the treatment of Venous Leg Ulcers (VLUs). Company will conduct a global ph 3 study.
M&A / COLLABORATION NEWS
Caribou Biosciences
Pfizer made a $25 million equity investment in the company. They are advancing their allogeneic CAR-T cell therapy pipeline, with multiple phase 1 studies and IND's planned.
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