Biopharma | January 07, 2026
Medera doses final patient in high-dose HFpEF gene therapy trial
Heart failure affects an estimated 64.3 million people worldwide
Heart failure affects an estimated 64.3 million people worldwide
Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline
Applications include detailed scientific rationale and supporting clinical evidence
The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively
INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway
The partnership also sets the stage for broader collaboration on rare disease treatments
TMS offers new hope to patients suffering from stroke, migraine, neuropathic pain, depression, and other disorders
The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers
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